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FDA Recalls

January 2011 - August 2011

• Recalls as of December 28, 2011
• Recalls as ofDecember 21, 2011
• Recalls as of December 14, 2011
• Recalls as of December 7, 2011
• Recalls as of November 30, 2011
• Recalls as of November 23, 2011
• Recalls as of November 30, 2011
• Recalls as of November 9, 2011
• Recalls as of November 2, 2011
• Recalls as of October 26, 2011
• Recalls as of October 19, 2011
• Recalls as of October 12, 2011
• Recalls as of October 5, 2011
• Recalls as of September 21, 2011
• Recalls as of September 14, 2011
• Recalls as of September 7, 2011
• Recalls of August 31, 2011
• Recalls of August 24, 2011
• Recalls as of August 17, 2011
• Recalls as of August 10, 2011
• Recalls as of August 3, 2011
• Recalls as of July 27, 2011
• Recalls as of July 20, 2011
• Recalls as of July 13, 2011
• Recalls as of July 6, 2011
• Recalls as of June 29, 2011
• Recalls as of June 22, 2011
• Recalls as of June 15, 2011
• Recalls as of June 8,2011
• Recalls as of June 1, 2011
• Recalls as of May 25, 2011
• Recalls as of May 18, 2011
• Recalls as of May 11, 2011
• Recalls as of May, 4, 2011
• Recalls as of April 27, 2011
• Recalls as of April 20, 2011
• Recalls as of April 13, 2011
• Recalls as of April 6, 2011
• Recalls as of March 23,2011
• Recalls as of March 16,2011
• Recalls as of March 2, 2011
• Recalls as of February 23, 2011
• Recalls as of February 16, 2011
• Recalls as of February 9, 2011
• Recalls as of February 2, 2011
• Recalls as of January 26,2011
• Recalls as of January 12, 2011
• Recalls as of January 5, 2011

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 28, 2011.

CLASS II

PRODUCT:

1) SKYLight Gamma Camera System; SKYLIGHT 8 FT, 3/8" SPECT. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model number: 2161-3000A. Recall # Z-0247-2012;2) SKYLight Gamma Camera System; SKYLIGHT 8 FT, 5/8" SPECT. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model number: 2161-3001A. Recall # Z-0248-2012;3) SKYLight Gamma Camera System; SKYLIGHT, 3/8", SPECT. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2160-3000A 4535-600-66661. Recall # Z-0249-2012;4) SKYLight Gamma Camera System; SKYLIGHT, 5/8", SPECT; The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2160-3001A. Recall # Z-0250-2012;5) SKYLight Gamma Camera System; SKYLIGHT, AZ, 8 FT, 3/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2161-3000B 4535-602-46831. Recall # Z-0251-2012;6) SKYLight Gamma Camera System; SKYLIGHT, AZ, 8 FT, 5/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2161-3001B 4535-602-55271. Recall # Z-0252-2012;7) SKYLight Gamma Camera System; SKYLIGHT, AZ, 9 FT, 3/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model number: 2160-3000B, 4535-602-46641. Recall # Z-0253-2012;8) SKYLight Gamma Camera System; SKYLIGHT, AZ, 9 FT, 5/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model number: 2160-3001B. Recall # Z-0254-2012;9) Precedence System; SYST, PRECEDENCE, 16 Slice 5/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2169-3001A 4535-602-50861. Recall # Z-0255-2012;10) Precedence System; SYST, PRECEDENCE, 16 Slice 3/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2169-3000A 4535-602-50851. Recall # Z-0256-2012;11) Precedence System; SYST, PRECEDENCE, 6 Slice 3/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2169-3002A 4535-602-53551. Recall # Z-0257-2012;12) Precedence System; SYST, PRECEDENCE, 6 Slice 5/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2169-3003A 4535-602-53561. Recall # Z-0258-2012

MANUFACTURER:  Recalling Firm: Philips Medical Systems, San Jose, CA, by letter dated September 27, 2011.  Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. Firm Initiated recall is ongoing.

REASON:  A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.

PRODUCT:

"***UPLIFT TECHNOLOGIES INC.***Bringing quality to life.***Model No.***CA200***Description***Lifting commode chair***Weight Range***80-300+ lb-136+ kg***" Labeling on product: "***1C0101 and K0061014***". A lifting commode chair that is self-powered (non-electric) and provides lifting assistance for those who have reduced mobility due to arthritis, post-operative conditions, degenerative joint disease, Parkinson's disease or other neuromuscular disorders. Recall # Z-0270-2012

MANUFACTURER:  Recalling Firm: Uplift Technologies Inc., Dartmouth, Canada, by fax, telephone or letter dated June 27, 2011.Manufacturer: Maxhealth Corp., Taipei, Taiwan. FDA initiated recall is ongoing.  

REASON:  The plastic seat does not meet manufacturing specifications. The seat may not fit the unit properly and may interfere with the unit's normal locking mechanism.

PRODUCT: 

1) Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 1-H63. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device. Recall #Z-0329-2012;2) Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 2-H63. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device. Recall # Z-0330-2012

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated October 6, 2011. Firm initiated recall is ongoing.

REASON:  The Product Models 1 & 2 has a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.

PRODUCT:

Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System. These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms (that contain the tube and solid state detector), x-ray generator and a patient table. This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities. Recall # Z-0331-2012

MANUFACTURER:  Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter dated October 3, 2011. Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.  

REASON:  The recall was initiated because Toshiba has confirmed that during patient transfer from a gurney to the catherization table, the tabletop may rotate unexpectedly when sufficient force is applied to the tabletop. The result of the tabletop rotating unexpectedly is the patient being transferred may fall from the tabletop.

PRODUCT:

Model H48: Head Ring Posts with part number 970.280 - re-usable components of the Frame Array Module (of the Optical Guidance Platform and Floor stand devices. The Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment for stereotactic radiosurgery or radiotherapy treatments on cranial extracranial lesions. Recall # Z-0332-2012

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated October 4, 2011. Firm initiated recall is ongoing.

REASON:  An anomaly has been identified with the Head Ring posts used by both the Optical Guidance Platform FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechanical stress resulting in possible failure during usage.

PRODUCT:

LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Application is loaded onto the Model 3120 programmers. These programmers are used during in-office follow-ups. The software version affected domestically is version 1.05 for COGNIS and TELIGEN and internationally is version 2.04 for COGNIS, TELIGEN, and PUNCTUA, ENERGEN, and INCEPTA. The PUNCTUA, ENERGEN, and INCEPTA are not currently approved in the US. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. The LATITUDE Patient Management System software is web-based and therefore at any point in time, there is only one (1) released version for each model number. The current version is 7.1. Both the programmer software and the LATITUDE remote monitoring system software similarly display the shock lead impedance measurements. Recall # Z-0333-2012

MANUFACTURER:  Boston Scientific CRM Corp., Saint Paul, MN, by letter dated October 2011.  Firm initiated recall is ongoing.

REASON:  Current Boston Scientific defibrillator systems measure shock lead impedances up to 200 ohms, and export results to the programmer and LATITUDE monitoring system via the Daily Measurements feature. A measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a Red Alert within LATITUDE (if activated). However, the measured value that prompted the alert is not displayed. Similarly, out-of-range impedance measurements are not plotted on programmer or LATITUDE trending graphs. Boston Scientific has received reports that, in some instances, this has made it more difficult for physicians to troubleshoot the system and determine whether the out-of-range impedance value truly reflected an underlying lead/system issue.

PRODUCT:

1) Dual Incu i (Atom Infant Incubator Model 100). Usage: A combination incubator and warmer for infants. Recall #Z-0337-2012;2) Incu i (Atom Infant Incubator Model 101). Usage: An incubator for infants. Recall #Z-0338-2012;3) Rabee Incu i (Atom Infant Incubator Model 102). Usage: An incubator for infants. Recall #Z-0339-2012;4) Infa Warmer i (Atom Infant Warmer Model 103). Usage: A warmer for infants. Recall # Z-0340-2012

MANUFACTURER:  Atom Medical Corp., Bunkyo-Ku, Japan, by letter dated August 18, 2011. Firm initiated recall is ongoing.

REASON:  The caster with lock on the radiant-warming open type incubator may become loose or break.

PRODUCT:

Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy treatment process. Recall # Z-0342-2012

MANUFACTURER:  Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated October 20, 2011. Manufacturer: Elekta Oncology Systems (Fmrl Philipp’s), Crawley, West Sussex,   UK. Firm initiated recall is ongoing.

REASON:  A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board.

PRODUCT:

1) Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. The recalled GEMINI TF 16 system units are identified as follows: Model Number: 882470 and Model #882473. Recall # Z-0343-2012;2) Philips GEMINI TF 64 Diagnostic CT X-ray/PET Imaging System, Catalog/Model #882471, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. Recall # Z-0344-2012

MANUFACTURER:  Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated October 28, 2011. Firm initiated recall is ongoing.

REASON:  In response to complaints received by Philips Medical concerning certain identified software errors reported by their customers, the firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of these PET/CT system units.

PRODUCT:

Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag. Recall # Z-0508-2012

MANUFACTURER:  Recalling Firm: DePuy Orthopedics, Inc., Warsaw, IN, by letters on November 9, 2011.Manufacturer: Symmetry Medical New Bedford Inc., New Bedford, MA. Firm initiated recall is ongoing.  

REASON:  DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the inability to properly thread the nut onto the bolt.

CLASS III

PRODUCT:

SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data. Recall # Z-0444-2012

MANUFACTURER:  SCC Soft Computer, Clearwater, FL, by letter on July 26, 2011. Firm initiated recall is ongoing.

REASON:  A test performed on the Roche Cobas Integra series of instruments when used with the GenInst/Dispatch listening program could cause incorrect flagging for a test result posted to the lab database.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  December 21, 2011.

CLASS I

PRODUCT:

Shoulder Flex Massage Device Device is an electric personal massage device labeled in part: "ShoulderFlex Deep-kneading Shiatsu* Model #SH61 *Read all instructions before using the massager* **WARNING NEVER wear a necklace or similar items while using this product Made in China." Personal use massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while user lies on a flat surface. Recall # Z-0172-2012

MANUFACTURER:  King International, Beaverton, OR, by letter on August 25, 2011 and by press release on August 31, 2011. Firm initiated recall is ongoing.

REASON:  The covered rotating mechanism can catch on user's clothing, jewelry (e.g. necklace), and hair. There have been reports of one death and strangulation associated with using the device.

PRODUCT:

AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses (disposable), Rx only, STERILE --- Device Listing # D033736. Packaged: 6 Soft Contact Lenses per unit carton or trial product 3 pack. AVAIRA (enfilcon A) SPHERE soft contact lenses are indicated for the correction of ametropia (myopia or hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Recall # Z-0350-2012

MANUFACTURER:  Recalling Firm: Coopervision Inc., Fairport, NY, by a press release on November 15, 2011, and by letter dated November 16, 2011.  Manufacturer: Coopervision Manufacturing, Ltd. Hamble, Southhampton. UK. Firm initiated recall is ongoing.

REASON:  Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses.

CLASS II

PRODUCT:

Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with the VACUETTE Blood Collection Needles and VACUETTE Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions. Item #450254. Recall # Z-0179-2012

MANUFACTURER:  Greiner Bio-One North America, Inc., Monroe, NC, by letter dated August 11, 2011. Firm initiated recall is ongoing.

REASON:  Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.

PRODUCT:

i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Recall # Z-0180-2012

MANUFACTURER:  Recalling Firm: Abbott Point Of Care Inc., Princeton, NJ, by letter dated September 2011. Manufacturer: Abbott Point of Care, Nepean Ontario, Canada. Firm initiated recall is ongoing.

REASON:  i-Stat cTnI cartridges beginning with letter "T" may exhibit a higher than expected variability in reported results. This increased variability may result in falsely elevated or falsely depressed results.

PRODUCT:

IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting. Recall # Z-0212-2012

MANUFACTURER:  Recalling Firm: AGFA Corp., Greenville, SC, by letter dated May 27, 2011.  Manufacturer: AGFA HealthCare Corp., Westerly, RI. Firm initiated recall is ongoing.

REASON:  Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR).

PRODUCT:  IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. Recall # Z-0272-2012

MANUFACTURER:  Recalling Firm: AGFA Corp., Greenville, SC, by letter on June 6, 2011.Manufacturer: AGFA HealthCare Corp., Westerly, RI. FDA initiated recall is ongoing.

REASON:  Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it.

PRODUCT:

1) ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8001; Individually Packaged Kit. The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. Recall # Z-0286-2012;2) ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8013, Provider Pack: 10 test (with lancet). The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. Recall # Z-0287-2012;3) ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8014, Provider Pack: 10 test (without lancet). The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. Recall # Z-0288-2012;4) ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8015, Screening Pack: 50 test (with lancet). The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. Recall # Z-0289-2012;5) ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8021, Screening Pack: 100 test (with lancet & capillary). The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. Recall # Z-0290-2012;6) ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8024, Provider Pack: 5 test. The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. Recall # Z-0291-2012

MANUFACTURER:  Recalling Firm: ImmuneTech, Inc., Foster City, CA, by letter dated November 4, 2011.Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is ongoing.

REASON:  ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination.

PRODUCT

Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch , Soluset Microdrip with Option-Lok; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; List 19208-01. Intended use: for the administration of fluids. Recall # Z-0292-2012

MANUFACTURER:  Recalling Firm: Hospira Inc., Lake Forest, IL, by letter dated November 10, 2011.Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.

REASON:  The float valve in the burette sticks to the burette wall and does not open or close properly.

PRODUCT:

Arrow International StimuCath (R) Continuous Nerve Block Kit, ASK-19608-SFH, Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia of analgesia techniques for periods not exceeding 72 hours. Recall # Z-0309-2012

MANUFACTURER:  Recalling Firm: Arrow International Inc., Reading, PA, by letter dated June 20, 2011.Manufacturer: Arrow International Inc., Asheboro, NC. Firm initiated recall is ongoing.

REASON:  Some of the outer trays used in the packaging were found to have an insufficient seal. Therefore, the packaging may have been compromised, and sterility of the product cannot be guaranteed.

PRODUCT

Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic system, digital. Recall # Z-0313-2012

MANUFACTURER:  Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated October 25, 2011.Manufacturer: Philips Medical Systems Gmbh, DMC, Development and Manufacturing Ctr., Hamburg, Germany. Firm initiated recall is ongoing.

REASON:  Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension, exposes printed circuit.

PRODUCT:

1) Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Primary Hip Prosthesis Femoral Stem SIZE 16 171 MM STEM LENGTH 12/14 NECK TAPER - STANDARD BODY - STANDARD NECK OFFSET TIVANIUM TI-6AL-4V ALLOY/TANTALUM STERILE. Item number: 00-7864-016-00. Recall # Z-0366-2012;2) Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems: FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER EXTENDED 46 MM NECK OFFSET SPOUT BODY SIZE E 55 MM BUILD-UP TIVANIUM TI-6AL-4V ALLOY STERILE. Item number: 00-9991-021-55. Recall # Z-0367-2012;3) Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems: FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER STANDARD 40 MM NECK OFFSET CONE BODY SIZE C 35 MM BUILD-UP TIVANIUM TI-6AL-4V ALLOY STERILE. Item number: 00-9996-019-35. Recall # Z-0368-2012

MANUFACTURER:  Zimmer Inc., Warsaw, IN, by letters on November 16, 2011. Firm initiated recall is ongoing.

REASON:  Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these lots had been split off during normal production and had not been included in the 2006 recall.

PRODUCT:

Philips Multi Diagnost Eleva with Flat Software R5.2.2. Philips MultiDiagnost Eleva system is intended to be Intended used as a multifunctional/Universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography. Recall # Z-0371-201

MANUFACTURER:  Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated November 14, 2011.Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.

REASON:  Displayed Dose Area Product (DAP) is displayed by a factor 100 too low.

PRODUCT

Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #491B. TA disposable temperature probe used in conjunction with a measuring/monitoring device to continuously measure/monitor a patient's core body temperature. Recall # Z-0372-2012

MANUFACTURER:  Cincinnati Sub-Zero Products Inc., Cincinnati, OH, by letter on November 1, 2011. Firm initiated recall is ongoing.

REASON:  Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error.

PRODUCT:

OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications. Item: 150368. Recall # Z-0417-2012

MANUFACTURER:  Biomet, Inc., Warsaw, IN, by letter dated November 1, 2011. Firm initiated recall is on going.

REASON: Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14x150).

PRODUCT:

1) Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy. PM2110, 2112, 2210, 2212 (Accent DR). Recall # Z-0429-2012;2) Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy. Models PM3110, 3112, 3210,3212 (Anthem). Recall # Z-0430-2012

MANUFACTURER:  St Jude Medical CRMD, Sylmar, CA, by letter dated September 22, 2011. Firm initiated recall is ongoing. 

REASON:  St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.

PRODUCT:

1) "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT** STERILE***ENDOTEC***” SIZE 1 x 0mm CAT 04-33-0001; SIZE 2 x 0mm CAT 04-33-0002; SIZE 3 x 0mm CAT 04-33-0003; SIZE 4 x 0mm CAT 04-33-0004; SIZE 5 x 0mm CAT 04-33-0005; SIZE 6 x 0mm CAT 04-33-0006. Tricompartmental Knee Replacement. Recall # Z-0431-20122) "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT** STERILE***ENDOTEC***" SIZE 1 x 2.5mm CAT 04-33-0011; SIZE 2 x 2.5mm CAT 04-33-0012; SIZE 3 x 2.5mm CAT 04-33-0013; SIZE 4 x 2.5mm CAT 04-33-0014; SIZE 5 x 2.5mm CAT 04-33-0015; SIZE 6 x 2.5mm CAT 04-33-0016. Tricompartmental Knee Replacement. Recall # Z-0432-2012;3) "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT*** STERILE***ENDOTEC***" SIZE 1 x 5mm CAT 04-33-0021; SIZE 2 x 5mm CAT 04-33-0022; SIZE 3 x 5mm CAT 04-33-0023; SIZE 4 x 5mm CAT 04-33-0024; SIZE 5 x 5mm CAT 04-33-0025; SIZE 6 x 5mm CAT 04-33-0026. Tricompartmental Knee Replacement. Recall # Z-0433-2012;4) "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT*** STERILE***ENDOTEC***" SIZE 1 x 7.5mm CAT 04-33-0031; SIZE 2 x 7.5mm CAT 04-33-0032; SIZE 3 x 7.5mm CAT 04-33-0033; SIZE 4 x 7.5mm CAT 04-33-0034; SIZE 5 x 7.5mm CAT 04-33-0035; SIZE 6 x 7.5mm CAT 04-33-0036. Tricompartmental Knee Replacement. Recall # Z-0434-20125) "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT*** STERILE***ENDOTEC***" SIZE 1 x 10mm CAT 04-33-0041; SIZE 2 x 10mm CAT 04-33-0042; SIZE 3 x 10mm CAT 04-33-0043; SIZE 4 x 10mm CAT 04-33-0044; SIZE 5 x 10mm CAT 04-33-0045; SIZE 6 x 10mm CAT 04-33-0046. Tricompartmental Knee Replacement. Recall # Z-0435-2012;6) "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***CAT.NO.***SIZE***" SIZE 3-3X0 CAT 04-63-2103; SIZE 3-4X0 CAT 04-632104; SIZE 3-5X0 CAT 04-63-2105; SIZE 3-6X0 CAT 04-63-2106. Tricompartmental Knee Replacement. Recall # Z-0436-2012;7) "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***CAT.NO.***SIZE***" SIZE 3-3X2.5 CAT 04-63-2113; SIZE 3-4X2.5 CAT 04-63-2114; SIZE 3-5X2.5 CAT 04-63-2115; SIZE 3-6X2.5 CAT 04-63-2116. Tricompartmental Knee Replacement. Recall # Z-0437-2012;8) "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC** CAT.NO.***SIZE***" SIZE 3-3X5 CAT 04-63-2123; SIZE 3-4X5 CAT 04-63-2124; SIZE 3-5X5 CAT 04-63-2125; SIZE 3-6X5 CAT 04-63-2126. Tricompartmental Knee Replacement. Recall # Z-0438-2012;9) "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***CAT. NO***SIZE***" SIZE 3-3X7.5 CAT 04-63-2133; SIZE 3-4X7.5 CAT 04-63-2134; SIZE 3-5X7.5 CAT 04-63-2135; SIZE 3-6X7.5 CAT 04-63-2136. Tricompartmental Knee Replacement. Recall # Z-0439-2012;10) "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***" Cat #: 04-33-1002 Modular Tibial Bearing 2 X 0 Cat #: 04-33-1003 Modular Tibial Bearing 3 X 0 Cat #: 04-33-1004 Modular Tibial Bearing 4 X 0 Cat #: 04-33-1005 Modular Tibial Bearing 5 X 0 Cat #: 04-33-1006 Modular Tibial Bearing 6 X 0. Tricompartmental Knee Replacement. Recall # Z-0440-2012;11) "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC*** " Size: 04-33-1012 Modular Tibial Bearing 2 X 2.5 04-33-1013 Modular Tibial Bearing 3 X 2.5 04-33-1014 Modular Tibial Bearing 4 X 2.5 04-33-1015 Modular Tibial Bearing 5 X 2.5 04-33-1016 Modular Tibial Bearing 6 X 2.5. Tricompartmental Knee Replacement. Recall # Z-0441-2012;12) "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***" Size: 04-33-1022 Modular Tibial Bearing 2 x 5 04-33-1023 Modular Tibial Bearing 3 X 5 04-33-1024 Modular Tibial Bearing 4 X 5 04-33-1025 Modular Tibial Bearing 5 X 5 04-33-1026 Modular Tibial Bearing 6 X 5. Tricompartmental Knee Replacement. Recall # Z-0442-2012; 13) "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***." Size: 04-33-1032 Modular Tibial Bearing 2 X 7.5 04-33-1033 Modular Tibial Bearing 3 X 7.5 04-33-1034 Modular Tibial Bearing 4 X 7.5 04-33-1035 Modular Tibial Bearing 5 X 7.5 04-33-1036 Modular Tibial Bearing 6 X 7.5. Tricompartmental Knee Replacement. Recall # Z-0443-2012

MANUFACTURER:  Endotec, Inc., Orlando, FL, by letter dated September 21, 2011. FDA initiated recall is ongoing.

REASON:  The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components

PRODUCT:

Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh. Recall # Z-0446-2012

MANUFACTURER:  Osteopore International PTE LTD, Singapore, Singapore, by letter dated April 27, 2011. Firm initiated recall is ongoing.

REASON:  Product sterility may be compromised.

PRODUCT:

Walgreens Quick Read Digital Thermometer; an electronic digital thermometer; Model WIC551226, UPC 31191708790. Recall # Z-0506-2012

MANUFACTURER:  Recalling Firm: Walgreen Co., Deerfield, IL, by e-mail on November 23, 2011.Manufacturer: Dongguan Dalang Vigor Electronics Mfy., Dongguan City, Guangdong  China. FDA Initiated recall is ongoing

REASON:  The thermometers have been reported to have inaccurate readings.

CLASS III

PRODUCT:

Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10. Recall # Z-0453-2012

MANUFACTURER:  Cepheid, Sunnyvale, CA, by letters on November 17, 2011. Firm initiated recall is ongoing.

REASON:  Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  December 14, 2011.

CLASS II

PRODUCT:

Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations. Recall # Z-0186-2012

MANUFACTURER:  Kerr/pentron Dba Kerr Corporation And Pentron Clinical, Orange , CA, by letter dated July 18, 2011. Firm initiated recall is ongoing. 

REASON:  There may be a curing problem that may cause cemented crowns to fall off after use of the product.

PRODUCT:

Invacare 600 lb. Bariatric Bed, Head motor extension cable used on component numbers BAR5490 and BAR5490IVC. These components are part of the following Bed Model Number(s): BAR600, BARPKGCA, BAR600IVC, BARPKGIVC-1633, and BARPKG.Recall # Z-0187-2012

MANUFACTURER:  Recalling Firm: Invacare Corp., Elyria, OH, by letters on September 19, 2011.Manufacturer: Invacare Corp., Sanford, FL. Firm initiated recall is ongoing.

REASON:  Invacare Corporation decided to recall the products because risk analysis reveals that miskeying or disconnection of the head motor extension cable during bed set-up may result in product damage, or in rare instances, the potential for fire.

PRODUCT:

1) IBO Blade, Right, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. Recall # Z-0195-2012; 2) IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. Recall # Z-0196-2012;3) Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. Recall # Z-0197-2012;4) Right IBO Blade, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901S2. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. Recall # Z-0198-2012;5) Left IBO Blade, for use with Stryker TPS or Core Reciprocating Saw, REF 5100-37-902S2. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. Recall # Z-0199-2012

MANUFACTURER:  Stryker Instruments Div. of Stryker Corp., Portage, MI, by letter dated October 18, 2011.  Firm initiated recall is ongoing.

REASON:  There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a broken blade, infection due to an unretrieved device component, complications associated with increased time under anesthesia to retrieve a broken blade, osteomyelitis of the mandible, or a pathological fracture due to faulty intervention or a secondary infection.

PRODUCT:

Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300. Recall # Z-0265-2012

MANUFACTURER:  Recalling Firm: Stryker Endoscopy, San Jose, CA, by letter dated October 25, 2011. Manufacturer: Stryker, Arroyo, PR. Firm initiated recall is ongoing.

REASON:  An increased number of complaints for tip breaks were observed for the 3.5mm Super 90-S SERFAS Energy Suction Probes manufactured from June to August 2011.

PRODUCT:

SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3. Recall #Z-0278-2012

MANUFACTURER:  Recalling Firm: Steris Corp., Mentor, OH, through SCC Soft Computer's proprietary Task Management System on March 22, 2011.Manufacturer: Steris Corp., Montgomery, AL. Firm initiated recall is ongoing.

REASON:  Potential for patient data to be sent to the wrong patient record. A software change affected how the Softlab handles recovery from certain types of table access conflicts. When such conflicts occur, this function has the potential to cause faulty writing to the database.

PRODUCT:

1) Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. Symbia S Series systems, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12. Recall # Z-0283-2012;2) Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.Symbia T Series systems, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12. Recall # Z-0284-2012

MANUFACTURER:  Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, letter dated October 14, 2011. Firm initiated recall is ongoing.

REASON:: Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications version VA60A with Foresight detectors firmware version v1.5.9.12 on the Symbia systems.  

PRODUCT:

Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital patient weighing scale; Made in China; Model 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate, reliable and repeatable weight measurements and features that make the weighing process simple, fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included). UPC Code – 892076002718. Recall # Z-0294-2012

MANUFACTURER:  Recalling Firm: Pelstar, LLC, Alsip, IL, by letter dated October 7, 2011.Manufacturer: Beaverite International Limited, Kowloon, Hong Kong SAR. Firm initiated recall is ongoing.

REASON:  There is a potential for an electrical short when installing or replacing the batteries in the remote display head of the scales. This short may cause the batteries to smoke, burn or burst.

PRODUCT:

Multigent Vancomycin Calibrators; Product Usage: The Multigent Vancomycin calibrators are inended for use in the calibration of the multigent vancomycin Vancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections. Catalog number: 6E44-01. Recall # Z-0297-2012

MANUFACTURER:  Microgenics Corp., Fremont, CA, by letter dated June 15, 2011. Firm initiated recall is ongoing.  

REASON:  The third party control material is recovering high, and outside the published range.

PRODUCT:

1) The Terumo Advanced Perfusion System 1, Catalog Number 801763, System 1 Base, 110 V Product Usage: The Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Recall # Z-0298-2012; 2) The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V Product Usage: The Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Recall # Z-0299-2012

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated November 8, 2011. Firm initiated recall is ongoing.

REASON:  1 US customer was operating the Advanced Perfusion System 1 to an unapproved, modified cable, which was in product development, to connect the system to an occluder for the Sarns Modular Perfusion System 8000. Five (5) of twelve (12) cables from Terumo Japan, which were in product development, were given to a US customer.

PRODUCT:

1) Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 (gray) Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment; Catalog number 816571. Recall #Z-0300-2012;2) Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment; Catalog number 801041. Recall # Z-0301-2012;3) Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment; Catalog number 801040. Recall # Z-0302-2012

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated November 10, 2011. Firm initiated recall is ongoing. 

REASON:  Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt washer was added as a validated running change to production to all roller pumps manufactured since February 2009. The felt washer should not have been installed at that time as there were not instructions on how to install it and there was a retaining ring that should have been added with the felt washer, but was not. As a result, the felt washer could come loose over time and could interfere with internal components of the pump. This interference could cause a non-recoverable pump stop which could require mitigation.

PRODUCT:

The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist. Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.Catalog Number 16422. Recall # Z-0303-2012

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone on November 7, 2011. Firm initiated recall is ongoing.

REASON:  Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connections between the board and the transformer.

PRODUCT:

Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neo-plastic diseases, as determined by a licensed medical practitioner. Recall # Z-0305-2012

MANUFACTURER:  Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated March 9, 2011.Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, UK. Firm initiated recall is ongoing.

REASON:  If "Confirm" or "Unconfirm" settings are clicked during the "Terminated Checking" phase of treatment delivery, Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends the delivered MUs to MOSAIQ a zero value.

PRODUCT:

Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning. Recall # Z-0307-2012

MANUFACTURER:  Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated June 23, 2011.Manufacturer: Elekta Instrument AB, Stockholm, Sweden. Firm initiated recall is ongoing.

REASON:  There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.

PRODUCT:

Roche Cobas c 111 Analyzer; The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analyzes are measured photo-metrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. Recall # Z-0311-2012

MANUFACTURER:  Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated October 18, 2011. Firm initiated recall is ongoing.

REASON:  Internal investigations have revealed a potential printer malfunction on the Cobas c 111 analyzer, where one or more numbers or characters can be missing on the hard copy result printout, or the printer may skip leaving blanks which may result in an incorrect print layout. The missing number of characters can be in any position, therefore it could be in the middle of a result, (e.g. 48.53 mmol instead of 148.53 mmol). The missing numbers or characters can affect any part of the printout, ( e.g. results, measurement units, or other text), possibly leading to incorrect treatment/diagnosis in some tests. Information presented on the analyzer screen , or transmitted to the host system are correctly displayed.

PRODUCT:

Elekta Leksell Gamma Knife C 1.2, 4 and 4C Product Usage: Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head structures. Recall # Z-0312-2012

MANUFACTURER:  Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated May 12, 2011.  Manufacturer: Elekta Instrument AB, Stockholm, Sweden. Firm initiated recall is ongoing.

REASON:  Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient.

PRODUCT:

Stereotactic Circular Collimator Product Usage: This device is intended to hold a patient's head in a fixed position and to localize and center the output of a linear accelerator (UNAC) to allow radiotherapy of brain tumors and other types of cerebral lesions. Recall # Z-0319-2012

MANUFACTURER:  Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated March 25, 2011.Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, UK. Firm initiated recall is ongoing.

REASON:  Recent newspaper articles outlined improper use of SRS Cone Collimator accessories that injured patients on Brainlab and Varian systems.

PRODUCT:

Elekta Synergy XVI R.4.5 and R4.6 Product Usage: To be used as part of radiation therapy treatment process. Recall # Z-0320-2012

MANUFACTURER:  Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated October 14, 2011. Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, UK. Firm initiated recall is ongoing.

REASON:  The software did not operate as expected.

PRODUCT:

1) Zimmer ZMR Hip System Instructions for Use, utilized for the following ZMR devices: Porous Stem, Nitrite Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splinted Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. Catalog Number 87-6203-884-01, Revision H, August 2009 and 87-6203-884-22, July 2010. Recall # Z-0321-2012;2) ZMR Porous Revision Hip Prosthesis Surgical Technique, utilized for the following ZMR devices: Porous Stem, Nitrite Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splinted Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. Catalog Number 97-9990-002-00 Revision 2, 2008. Recall # Z-0322-2012;3) ZMR Crossover Instrumentation, utilized for the following ZMR devices: Porous Stem, Nitrite Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splinted Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. Catalog Number 97-9990-007-00 Revision 1, 2010. Recall #Z-0323-2012;4) ZMR Over the Junction Instruments for Revision, utilized for the following ZMR devices: Porous Stem, Nitrite Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splinted Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. Catalog Number 97-9990-006-00 Revision 1, 2010. Recall # Z-0324-2012

MANUFACTURER:  Zimmer Inc., Warsaw, IN, by letter dated August 26, 2011. Firm initiated recall is ongoing.

REASON:  This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use.

PRODUCT:

TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin). Recall #Z-0341-2012

MANUFACTURER:

Recalling Firm: Radiometer America Inc., Westlake, OH, by telephone on September 27, 2011. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.

REASON:  Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use.

PRODUCT:

1) Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure. Recall # Z-0356-2012;2) Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAU Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure. Recall # Z-0357-2012;3) Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU. Recall # Z-0358-2012

MANUFACTURER:  Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated October 14, 2011.Manufacturer: Integra, Burlington MA, Inc., Burlington, MA. Firm initiated recall is ongoing.

REASON:  A loose screw may result in shifting of components and improper function of the turret or actuator assembly.

PRODUCT:

TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. Model numbers: H191113, H191034, H191105, H191154, H191046, H191053, H191044, H191015, H191035, H191108, 191152, H191140, H191069, H191017, H191027, H191109, 191130, H191002, H191071, H191024, H191078, H191111, 191072, H191102, H191074, H191087, H191151, H191125, 191018, H191058, H191038, H191115, H191085, H191032, 191077, H191023, H191103, H191095, H191163, H191146, 191124, H191138, H191093, H191097, H191040, H191030, 191029, H191060, H191066, H191122, H191054, H191126, 191114, H191082, H191067, H191081, H191005, H191013, 191116, H191051, H191094, H191052, H191031, H191021, 191048, H191139, H191099, H191020, H191039, H191128, 191156, H191057, H191061, H191112, H191049, H191083, 191008, H191123, H191065, H191119, H191089, H191120, 191092, H191134, H191129, H191056, H191090, H191033, 191047, H191037, H191076, H191007, H191028, H191080, 191106, H191118, H191073, H191117, H191155, H191086, 191141, H191025, H191036, H191042, H191079, H191135, 191010, H191100, H191107, H191127, H191063, H191070, 191153, H191026, H191096, H191014, H191064, H191059, 191009, H191142, H191068, H191001, H191132, H191011, 191003, H191136, H191022, H191121, H191016, H191012, 191045, H191101, H191088, H191041, H191043, H191150, 191019, H191055, H191133, H191131, H191091, H191098, 191006 and H191110. Recall # Z-0364-2012

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on November 4, 2011. Firm initiated recall is ongoing.

REASON:  An anomaly has been identified with the TrueBeam and TrueBeam STx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape.

PRODUCT:

1) Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0373-20122) Luxtec UltraLite Headlight System with 9ft premium bifurcated cable Model: AX2100BIF Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0374-2012;3) Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0375-2012;4) Luxtec UltraLite Headlight System with short linkage Model: AX 1375BIFSL Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0376-2012;5) Luxtec UltraLite Headlight System sweatband Model: AXI385BIF Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0377-2012;6) Luxtec UltraLite Headlight System sweatband with short linkage Model: AXI385BIFSL Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0378-2012;7) Mark II Headlight module-black Model: 001380LX Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0379-2012;8) Mark II Headlight module-black with short linkage Model: 001380LXSL Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0380-2012;9) UltraLite Headlight module-grey Model: 001328 Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0381-2012

MANUFACTURER:  Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated October 10, 2011, via FedEx, email or telephone.Manufacturer: Integra Burlington MA, Inc., Burlington, MA. Firm initiated recall is ongoing.

REASON:  Headlight assembly (module) may become loose and separate from the headband assembly.

CLASS III

PRODUCT:

Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only. The device is intended to be used as a staple line buttress. Recall # Z-0274-2012

MANUFACTURER:  Synovis Surgical Innovation Div. of, Saint Paul, MN, by letter dated October 26, 2011. Firm initiated recall is ongoing.

REASON:  Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  December 7, 2011.

CLASS II

PRODUCT:

1) Probe, Tactile, Left, ASM, Long, Part #962009S. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. Recall # Z-0001-2012;2) Probe, Tactile, Right, ASM, Long, Part #962011S. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. Recall # Z-0002-2012

MANUFACTURER:  Medtronic Navigation, Inc., Louisville, CO, by letter dated Jan 20, 2011. Firm initiated recall is complete.

REASON:  Distal end of tactile probe may break off during use.

PRODUCT:

Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks. Recall # Z-0039-2012

MANUFACTURER:  Recalling Firm: Richard-Allan Scientific Co., Kalamazoo, MI, by letter on August 12, 2011. Manufacturer: Microm International Gmbh, Walldorf, Germany. Firm initiated recall is ongoing.

REASON:  The firm has received two complaints of finger lacerations in operators of this device.

PRODUCT:

Medtronic Arctic Front Catheter, Sterile EO, Model 2AF282 and 2AF231 ( not distributed in US) Product Usage: The Medtronic CryoCath System consists of a Cryoablation console, cardiac Cryoablation catheters, connection components and accessories. The Arctic Front Cardiac Cryoablation Catheter is an over the wire Balloon catheter. The inside of the Balloon at the distal end of the Cryoablation Catheter reaches temperatures of -50 C or colder when refrigerant is injected from the console to the inside of the balloon. Arctic Front Cardiac Cryoablation catheters are introduced into the vasculature by traditional minimally invasive techniques. The CryoConsole houses the electrical and mechanical components as well as proprietary software for controlling and recording a cryotherapy procedure with Arctic Front and/or the Freezor family of catheters. It stores and controls the delivery of the liquid refrigerant through the coaxial umbilical to the catheter, recovers the refrigerant vapor from the catheter under constant vacuum, and disposes of the refrigerant through the hospital scavenging system. Multiple features are built into the catheter and the CryoConsole system to ensure safety. Model Number: 2AF282. Recall # Z-0149-2012

MANUFACTURER:  Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, by letter dated August 2011, hand delivered by Medtronic Field Representatives on August 29, 2011. Manufacturer: Medtronic CryoCath LP, Kirkland, Canada.  Firm initiated recall is ongoing.

REASON:  Product distributed with incorrect programming that may result in false expired catheter notifications.

PRODUCT: 

ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual, qualitative result and is intended for professional use only. The ProScreen Drugs of Abuse Cup is not for legal or medical diagnostic purposes. This device is not intended for workplace testing. For diagnostic and treatment purposes, consult with a healthcare or substance abuse professional. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method. Recall # Z-0152-2012

MANUFACTURER:  Ameditech Inc., San Diego, CA, by letter on June 9, 2011. Firm initiated recall is ongoing.

REASON:  The recalled products are mislabeled. If the USD customer receives the FirstCheck tes, there will be no instructions for use for the test.

PRODUCT:

ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1L75-25. The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver and kidney transplant patients receiving cyclosporine therapy. Recall # Z-0162-2012

MANUFACTURER:  Recalling Firm: Abbott Laboratories, Abbott Park. IL, by letter dated October 7, 2011.Manufacturer: Fujirebio Diagnostics, Inc., Malvern, PA. Firm initiated recall is ongoing.

REASON:  The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision.

PRODUCT: 

1) BioPro Femoral Head 28 mm -6 mm, Item 19003. Orthopedic femoral head for implantation. Recall # Z-0163-2012; 2) BioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation. Recall # Z-0164-2012

MANUFACTURER:  Biopro, Inc., Port Huron, MI, by telephone on September 21, 2011 and by letter dated September 29, 2011. Firm initiated recall is complete.

REASON:  BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.

PRODUCT:

1) Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK. Recall # Z-0165-2012;2) Abbott brand IntraLase Femtosecond Laser System, Model 3; Catalog Numbers: 20004D/J/K, R20004J/K; Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK (lntraLase Enabled Keratoplasty) and corneal harvesting; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK. Recall # Z-0166-2012;3) Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K; Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK. Recall # Z-0167-2012

MANUFACTURER:  AMO Manufacturing USA, LLC, Milpitas, CA, by letter dated October 12, 2011. Firm initiated recall is ongoing.

REASON:  The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or deeper) created using the Laser System.

PRODUCT:

Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis. Recall # Z-0173-2012

MANUFACTURER:  Recalling Firm: Baxter Healthcare Renal Div., McGaw Park, IL, by visit on September 19, 2011. Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is complete.

REASON:  The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.

PRODUCT:

1.0mL 28 G x 1/2" blister packaged insulin syringe, Catalog Number 329424; Intended use: Subcutaneous injection of insulin. K024112 D039612. Recall # Z-0174-2012

MANUFACTURER:  Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, byletter dated June 15, 2011.Manufacturer: BD Medical - Diabetes Care, Holdrege, NB. Firm initiated recall is ongoing.

REASON:  Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.

PRODUCT:

Stryker Mantis Rod Inserter Assembly Stryker Mantis Rod Inserter Inner Shaft IS2097MAN Mantis Rod Inserter Shaft Used to facilitate insertion and delivery of a Mantis rod. Recall # Z-0175-2012: 

MANUFACTURER:  Recalling Firm: Stryker Spine, Allendale, NJ, by letter, dated June 24, 2011. Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.

REASON:  There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter.

PRODUCT:

Clinical Chemistry Urea Nitrogen a) List Number 7D75-21 and b) 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine. Recall # Z-0189-2012

MANUFACTURER:  Recalling Firm: Abbott Laboratories, Inc., Irving, TX, by letterson October 3, 2011.Manufacturers: Thermofisher Scientific, Middletown, VA;

Abbott Laboratories, Abbott Park, IL. Firm initiated recall is ongoing.

REASON:  The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate matter has been identified as Aureobasidium fungus species.

PRODUCT:

DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers. The XR 46 performs DXA scans of the AP Spine, Hip, Forearm, Lateral Spine, and Whole Body, as well as other user selectable sites. It provides BMD (g/cm2), Area (cm2), and BMC (g) values. It compares these values to gender and ethnic matched reference populations and provides T-Score and % young Reference, Z- Score and % age matched, and long term and short term change values. This includes sBMD (mg/cm2). The XR 46 performs soft tissue assessment and provides lean mass, fat mass, percent fat, and total soft tissue values for all scan sites, including Whole Body. The XR 46 includes a Report writer that allows the operator to customize the appearance of their report stand to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their report for each of these ranges. The bone density measurements from the XR 46 can be used as an aid to physicians in determining fracture risk. Part Number 434A133. Recall #Z-0213-2012

MANUFACTURER:

Recalling Firm: Cooper Surgical, Inc., Trumbull, CT, by letter dated September 23, 1011. Manufacturer: Norland, A CooperSurgical Co., Fort Atkinson, WI. Firm initiated recall is ongoing.

REASON:  The DICOM Software, could lead to improper patient information getting into a previous patient's record.

PRODUCT:

Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data. Recall # Z-0261-2012

MANUFACTURER:  SCC Soft Computer, Clearwater, FL, via the SCC Soft Computer proprietary Task management system on August 8, 2011. Firm initiated recall is ongoing.

REASON:  A client reported a flagging error where the result was flagged as critical in the Instrument Menu but the printed report did not show the corresponding flag.

PRODUCT:

Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, a) Super Sheath 8F x 11 cm, 038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B; b) Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1; c) Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B. The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature. Recall # Z-0264-2012

MANUFACTURER:  Recalling Firm: Boston Scientific Corp., Maple Grove, MN, by letter dated November 21, 2011.Manufacturer: Togo Medikit Co., Ltd., Miyazaki-ken, Japan. Firm initiated recall is ongoing.

REASON:  Boston Scientific was informed through product complaints that the 0.035" ID dilator may be labeled incorrectly as a 0.038" ID dilator.

PRODUCT:

Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms). Catalog Number(s): MS18597 and MS18852. Recall # Z-0281-2012

MANUFACTURER:  Draeger Medical, Inc., Telford, PA, by letter on October 25, 2011. Firm initiated recall is ongoing.

REASON:  Complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2. measurements.

PRODUCT:

1) DePuy Mitek Panalock Loop, Lupine Anchor Catalog #210704 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. Recall # Z-0314-2012;2) DePuy Mitek Lupine Loop Plus w/ Orthocord Catalog #210708 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. Recall # Z-0315-2012;3) DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. Recall # Z-0316-2012;4) DePuy Mitek Lupine Loop Rapide w/ Orthocord Catalog #210711 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. Recall # Z-0317-2012;5) DePuy Mitek Panalock Loop w/ Orthocord Catalog #222980 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. Recall #Z-0318-2012

MANUFACTURER:  Recalling Firm: DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, by letter dated October 31, 2011. Manufacturer: Ethicon SARL, Neuchtel, Switzerland. Firm initiated recall is ongoing.

REASON:  Incorrect suture configuration.

CLASS III

PRODUCT:

1) 37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0153-2012;2) 37% Etching Gel-1ml syringe 20 pk, part # T06A The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0154-2012;3) 37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0155-2012;4) 37% Etching Gel-3ml syringe, part #N01H The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall:# Z-0156-2012;5) 37% Etching Gel-5ml syringe, part #N01IB The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0157-2012

MANUFACTURER:  Kerr/pentron Dba Kerr Corporation and Pentron Clinical, Orange, CA. by letter dated May 31, 2011. Firm initiated recall is ongoing.

REASON:  Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  November 30, 2011.

CLASS II

PRODUCT:

Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant. Recall # Z-0143-2012

MANUFACTURER:  Bioplate Inc., Los Angeles, CA, by letter dated March 18, 2010. Firm initiated recall is ongoing.

REASON:  There is potential defect in seal of the sterile barrier containing the device.

PRODUCT:

1) RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument Cases DJO surgical. The product is intended to be used to ream prepare the humeral bone for accepting the implant. It has a spring loaded alignment pin on the proximal (reaming) end used in both alignment of the reamer and as an indication that the reamer has been seated fully. DJO Surgical Part Number 804-02-013, 804-02-014, and 804-02-015.Recall # Z-0150-2012; 2) RSP Baseplate Rim Planer (Size 32, 36, 40): DJO Surgical Instruments and Instrument Cases DJO surgical. The Baseplate Rim Planer is used to prepare the bone around the peripheral rim of the reamed socket. It has a spring loaded alignment pin on the proximal (cutting) end used in both alignment of the planer and as an indication that the planer has been seated fully. DJO Surgical Part Number 804-03-010, 804-03-034, and 804-03-035.Recall # Z-0151-2012

MANUFACTURER:  Encore Medical, LP, Austin, TX, by letter dated September 28, 2011. Firm initiated recall is ongoing.

REASON:  The alignment pins cannot be consistently cleaned using the technique provided in the cleaning/sterilization section of the instrument IFU.

PRODUCT:

Spectra Optia Apheresis System, REF: 61000. A blood component separator used for therapeutic plasma exchanges. Recall # Z-0191-2012

MANUFACTURER:  Caridian BCT, Inc., Lakewood, CO, by letter dated September 2011. Firm initiated recall is ongoing.

REASON:  Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.

PRODUCT:

Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300. Recall # Z-0265-2012

MANUFACTURER:  Recalling Firm: Stryker Endoscopy, San Jose, CA, by letter dated October 25, 2011.Manufacturer: Stryker, Arroyo, PR. Firm initiated recall is ongoing.

REASON:  An increased number of complaints for tip breaks were observed for the 3.5mm Super 90-S SERFAS Energy Suction Probes manufactured from June to August 2011.

PRODUCT: 

STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6. Recall # Z-0279-2012

MANUFACTURER:  Recalling Firm: Steris Corp. Mentor, OH, by letter on October 17, 2011.Manufacturer: Steris Corp, Montgomery, AL. Firm initiated recall is ongoing.

REASON:  Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to move the table top out of the full right tilt position.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 23, 2011.

CLASS I

PRODUCT:

Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RIO GUIDANCE MODULE, 200294 RIO CAMERA STAND ASSEMBLY***PN 203999 SN ROB 125 2010-12 V 100/120/230 A 9.6/8.0/4.2 Hz 50/60 Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995 UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90. RIO System - The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Tactile Guidance System v2.0 is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be approriate, and where reference to rigid anatomical bony structures can be identified relative to a CT base model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement. Recall Z-0146-2012

MANUFACTURER:  Mako Surgical Corp., Davie, FL, by letter dated February 1, 2011, Firm initiated recall is ongoing.

REASON:  Software issue that exist that could potentially result in a bone resection. No adverse events reported

CLASS II

PRODUCT:

Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges. Recall # Z-0069-2012

MANUFACTURER:  Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter on August 31, 2011. Firm initiated recall is ongoing.

REASON:  Firm has confirmed customer complaints for low recovery of QC and patient samples.

PRODUCT:

Bard Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog Number: 5950008. Intended for use in the reconstruction of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair hernias and deficiencies caused by trocars. Recall Z-0144-2012

MANUFACTURER:  Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter on October 4, 2011.

Manufacturer: Bard Shannon LTD, Humacao, PR. Firm initiated recall is complete.

REASON:  Mislabeled: Bard Ventralex" ST Medium Circle was packaged in a pre-printed carton identified for a Bard Ventralex" ST Large Circle.

PRODUCT: 

MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number 8071M5 distributed in Europe/Middle East/Africa Part Number 8071M9 distributed in Hong Kong, Korea, Malaysia. Recall # Z-0145-2012

MANUFACTURER:  Merz Aesthetics, Inc., Franksville, WI, by letter dated August 15, 2011. Firm initiated recall is ongoing.

REASON: There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be alerted to the potential for product that my leak pass the plunger at the proximal end of the syring. The defect may result in infection requiring medical intervention to prevent impairment or damage. To date Merz has not received reports of any adverse events linked to the use of the syringes with this defect.

PRODUCT: 

Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK. Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomagraphy. Recall # Z-0147-2012

MANUFACTURER:  Medrad Inc, Indianola, PA, by letter dated October 24, 2011, Firm initiated recall is ongoing.

REASON:  Packaging may exhibit open seals - sterility compromised.

PRODUCT:

Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209. Recall # Z-0184-2012

MANUFACTURER:  Greiner Bio-One North America, Inc., Monroe, NC, by letter on August 11, 2011. Firm initiated recall is ongoing.

REASON:  Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.

CLASS

PRODUCT

BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated processing of skin punctures samples from infants, children, geriatric, oncology, and critical care patients. Catalog # 363706. Z-0176-2012

MANUFACTURER:  Becton Dickinson & Company, Franklin Lakes, NJ, by on-site visit on February 11, 2011, Firm initiated recall is complete

REASON:  BD Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive.

Please visit our websites at www.mdiconsultants.comfor more information on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 16, 2011.

CLASS II

PRODUCT:

1) 8F Safe Sheath Introducer, Catalog number: V18. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure. Recall # Z-3064-2011;2) 8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF. The Smart Port CT Implantable Port is a Single Titanium Port System with Attachable 8.0 Fr. Polyurethane Catheters and 8Fr. Introducer Kit. Recall # Z-3065-2011 

MANUFACTURER: Angiodynamics, Inc., Manchester, GA, by letter dated August 1, 2011. Firm initiated recall is ongoing.

REASON:  The product may contain an incorrect size catheter and introducer.

PRODUCT:

Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill. Imaging processing System. Recall # Z-3184-2011

MANUFACTURER:  Recalling Firm: Straumann Manufacturing Inc., Andover, MA, by letter dated August 4, 2011.  Manufacturer: Institut Straumann AG, Basel, Switzerland. Firm initiated recall is ongoing.

REASON:  Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed.

PRODUCT:

4D Integrated Treatment Console v 8.6 with ARIA RT Chart v8.5, all of 4DITC v 8.3; Designed to assist the operator of a radiation therapy device in providing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. Model No. H51. Recall # Z-3194-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on on July 21, 2011. Firm initiated recall is ongoing.

REASON:  The 4D Integrated Treatment Console may erratically fail to load the planned physical wedge accessory without warning or notification when receiving an approved plan from the oncology information system.

PRODUCT:

COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). The COULTER DxH Cell Lyse is an erythrocyte lytic agent used for quantitative determination of hemoglobin, enumeration of NRBC, and counting and sizing leukocytes on UniCel DxH 800 Coulter Cellular Analysis System. Recall # Z-3263-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on August 1, 2011Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

REASON:  The recall was initiated because Beckman Coulter identified unexpected high particle counts in the lots of DxH Cell Lyse listed. These lots may generate high background counts; could result in a falsely elevated Total Nucleated Count (TNC) of up to 50 cells/L; or may also result in recovery of TNC values that were higher than expected for Level 1 of the Body Fluid Control.

PRODUCT:

1) PERPOS PLS System, Single Use; CATALOG #'s: a) 9045-01 & b) 9045-02. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. Recall # Z-0045-2012;2) Reusable BONE-LOK PLS System; Catalog #'s: a) 9039-01 and b) 9039-02. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. Sold in Europe. Recall # Z-0046-2012;3) PERPOS Driver; Catalog # 6112. A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02), a component of the Reusable BONE-LOK PLS System (9039-01, 9039-02), or as a stand-alone tool. Recall # Z-0047-2012

MANUFACTURER:  Interventional Spine Inc., Irvine, CA, by letter dated March 15, 2011. Firm initiated recall is ongoing.

REASON:  This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this product may result in a delay of the surgical procedure.

PRODUCT:

ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Cartridge; Catalog Number: OM-6007; The MiniMagnum Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-Iabral reconstruction, biceps tenodesis and deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions. Recall # Z-0049-2012

MANUFACTURER:  ArthroCare Corp., Sunnyvale, CA, by letter dated May 10, 2011. Firm initiated recall is ongoing.

REASON :  ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant.

PRODUCT:

1) Base Camp First Aid Kit, Part Number 4150, UPC 0-91966-04150-3, contains 171 pieces. The kit is labeled in parts: "***BASE CAMP FIRST AID KIT***171 PIECE*** 6 IODINE PREP PADS***". First aid kit. Recall # Z-0119-2012;2) ARC DISASTER KIT (American Red Cross), Part Number 7201, UPC 0-91966-04708-6, The kit is labeled in parts: "***American Red Cross***Item 7201*** 2 IODINE PREP PADS*** ". First aid kit. Recall # Z-0120-2012;3) Highlands First Aid Kit, Part Number 4116, UPC 0-91966-04116-9, contains 65 Pieces. The kit is labeled in parts: "***HIGHLANDS FIRST AID KIT***MODEL 4166*** 1 IODINE PREP PADS***”. First aid kit. Recall # Z-0121-2012;4) Mountain First Aid Kit, Part Number 4118; UPC 0-91966-04118-3, contains 88 Pieces. The kit is labeled in parts: "***MOUNTAIN FIRST AID KIT***MODEL 4118*** 1 IODINE PREP PADS*** First aid kit. Recall # Z-0122-2012;5) Wilderness First Aid Kit, Part Number 4120; UPC 0-91966-04120-6, contains 110 Pieces. The kit is labeled in parts: "***WILDERNESS FIRST AID KIT***MODEL 4120*** 2 IODINE PREP PADS***First aid kit. Recall # Z-0123-2012

MANUFACTURER:  Lifeline First Aid LLC, Wilsonville, OR, by letter dated July 7, 2011. Firm initiated recall is ongoing.

REASON:  The first aid kits are recalled because the kits contain Iodine Prep Pad single use wipes which were recalled by Triad.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  November 09, 2011.

CLASS I

PRODUCT:

Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to provide support to a patient. Model numbers 5803, 5855, 5890, 5891, 5892, 5895, 5927, 5840-726, 5840-831, 5943, 5843A, 5996, 5996I and 6977. Recall # Z-0073-2012

MANUFACTURER: Mizuho Orthopedic Systems Inc., Union City, CA, by letters dated July 29, 2011. Firm initiated recall is ongoing.

REASON:  Reports of injury related incidents while using the Mizuho OSI Modular Table System.

CLASS II

PRODUCT:

CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste products and then returning the filtered blood back to the patient. Product Code: 03-2962-3. Recall # Z-3269-2011

MANUFACTURER:  Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, by letter dated August 11, 2011. Manufacturer: Fresenius Medical Care, Reynosa, Tamulipas, Mexico. Firm initiated recall is ongoing.

REASON:  Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions.

PRODUCT:

OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft. Part Number 800-1212. Recall # Z-0008-2012

MANUFACTURER:  Osteomed, LP, Addison, TX, by letter dated June 7, 2011. Firm initiated recall is ongoing.

REASON:  Two of the Implant Driver Assembly tips were reported to break during surgery.

PRODUCT:

MDC PACS - release R2.3 SP1. A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). Recall # Z-0032-2012

MANUFACTURER:

Recalling Firm: Philips Healthcare Inc., Andover, MA,by letter dated August 2011.

Manufacturer: CDP LTD, PETACH TIKVA, Israel. Firm initiated recall is ongoing.

REASON:

Clinical measurements on true size printouts may be inaccurate

PRODUCT:

1) SYNCHRON CX4 Clinical System Part #: 758300 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0124-2012;2) SYNCHRON CX4 Delta Clinical System Part #: 468233 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Z-0125-2012;3) SYNCHRON CX4 CE Clinical System Part #: 756600 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0126-2012;4) SYNCHRON CX5 Clinical System Part #: 759300 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0127-2012;5) SYNCHRON CX5 CE Clinical System Part #: 448700 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0128-2012;6) SYNCHRON CX7 Clinical System Part #: 756602 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0129-2012;7) SYNCHRON CX7 Clinical System Part #: 756602 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0130-2012;8) SYNCHRON CX7 Delta Clinical System Part #: 468205 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0131-2012;9) SYNCHRON CX9 Delta ALX System Part #: 473513 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0132-2012

MANUFACTURER:  Beckman Coulter Inc., Brea, CA, by letter dated September 20, 2010. Firm initiated recall is ongoing. 

REASON:  Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems.

PRODUCT:

CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Recall # Z-0142-2012

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated September 23, 2011. Firm Initiated recall is ongoing.

REASON:  Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC or battery power are restored.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 02, 2011.

CLASS II

PRODUCT:

1) ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Tapping Variable Screw Caddy (176-513). This instrument is a precision device which incorporates a measuring function. Recall # Z-2984-2011;2) ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516). This instrument is a precision device which incorporates a measuring function. Recall #Z-2985-2011

MANUFACTURER:  Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis, TN, by letters on July, 2011.Manufacturer: Symmetry Medical, Inc., Manchester, NH. Firm initiated recall is ongoing.

REASON:  Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws.

PRODUCT:

The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery system. Endoscopic Clipping Device, Hemorrhoidal Ligator. The device is used for clip placement within the GI tract for hemostatis ( mucosal defects, bleeding ulcer, arteries, polyps); endoscopic marking; and anchoring to affix jejunal feeding tubes to the wall of the small bowel, as a supplementary method for closure of GI tract luminal perforation <20 mm that can be treated conservatively. Recall # Z-3056-2011

MANUFACTURER:  Recalling Firm: Boston Scientific Corp., Marlborough, MA, by letter dated August 12, 2011.Manufacturer: Medventure Technology Corp., Jeffersonville, IN. Firm initiated recall is ongoing.

REASON: Boston Scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip, resulting in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn.

PRODUCT:

LATITUDE Patient Management System Communicator, Model 6482. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. Recall # Z-3183-2011

MANUFACTURER:  Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN, by telephone on May 25, 2011.  Manufacturer: Benchmark Electronics Inc., Winona, MN. Firm initiated recall is ongoing.

REASON:  Boston Scientific has identified two occurrences where the LATITUDE system did not process a data payload, which is the information uploaded to the LATITUDE system from a remote interrogation of the implanted device. These occurrences resulted in non-displayed payloads because the data is not posted to the website. If the payload is not displayed, the pertinent data will not be available on the LATITUDE website for clinical review. This includes any red or yellow alerts that may have been associated with that payload. No patient deaths or injuries have been associated with this communicator behavior.

PRODUCT:

1) ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 2.0 SUTURE, REF 5100-002, 1 each, STERILE R, Product Usage: The instrument is used as a soft tissue anchor. Recall # Z-0058-2012;2) ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 0 SUTURE, REF 5100-004, 1 each, STERILE R, Product Usage: The instrument is used as a soft tissue anchor. Recall # Z-0059-2012;3) ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2.0 SUTURE, REF 5100-006, 1 each, STERILE R, Product Usage: The instrument is used as a soft tissue anchor. Recall # Z-0060-2012;4) ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 0 SUTURE, REF 5100-008, 1 each, STERILE R, Product Usage: The instrument is used as a soft tissue anchor. Recall # Z-0061-2012;5) ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2 SUTURE, REF 5100-0010, 1 each, STERILE R, Product Usage: The instrument is used as a soft tissue anchor. Recall # Z-0062-2012;6) ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 0 SUTURE, REF 5100-0012, 1 each, STERILE R, Product Usage: The instrument is used as a soft tissue anchor. Recall #Z-0063-2012;7) ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 2 SUTURE, REF 5100-0014, 1 each, STERILE R, Product Usage: The instrument is used as a soft tissue anchor. Recall # Z-0064-2012;8) ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 5.0mm, 0 SUTURE, REF 5100-0016, 1 each, STERILE R, Product Usage: The instrument is used as a soft tissue anchor. Recall # Z-0065-2012;9) ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 5.0mm, 2 SUTURE, REF 5100-0018, 1 each, STERILE R, Product Usage: The instrument is used as a soft tissue anchor. Recall # Z-0066-2012;10) ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 7.5mm, 2 SUTURE, REF 5100-0020, 1 each, STERILE R, Product Usage: The instrument is used as a soft tissue anchor. Recall # Z-0067-2012

MANUFACTURER:  Wright Medical Technology Inc., Arlington, TN, by letter dated September 20, 2011. Firm initiated recall is ongoing.

REASON:  The product is labeled with an expiration date without adequate justification.

PRODUCT:

MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564155341***SN US11401652***". Note: REF 453564155341, REF 453564181201, and 453564180091 are subject to recall. REF is the firms Service Number which identifies the device. Product Usage The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization of the MR scanner. Recall # Z-0106-2012

MANUFACTURER:  Invivo Corp., Orlando, FL, by letter dated September 9, 2011. Firm initiated recall is ongoing.

REASON:  During transport of the system's cart with a docked Display Controller Unit (DCU), a front caster (wheel) may become loose and fall off causing the cart to become unbalanced and fall.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  October 26,  2011.

 CLASS II

PRODUCT:
Juggerknot system, REF 91200, Soft Anchors, -Two implants size 1, USA STERILE. Product Usage: The JuggerKnot Soft Anchors include various size ranges, each consisting of a coreless sleeve and suture(s) assembled on an inserter instrument. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device. Recall # Z-3109-2011

MANUFACTURER:  Biomet, Inc., Warsaw, IN, by telephone on July 08, 2011 and letters dated July 21, 2011. Firm Initiated recall is ongoing.

REASON:  The firm initiated the recall due to 12 reports of the device packaging being punctured by the device, resulting in loss of implant sterility.

PRODUCT:
ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCG45; SCW45; CTS45; SCB45; CTS45NK; 6CB45 and. The ETS Compact-Flex45 Articulating Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. Recall # Z-3187-2011

MANUFACTURER:  Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letter dated August 11, 2011. Manufacturer: Ethicon LLC, Guaynabo, PR. Firm initiated recall is ongoing.

REASON:  Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH ETS Compact Flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the sterility of the device.

PRODUCT:
PCR Eleva Radiological Image Processing System with software R.1.2. A computed radiography image processing system. Recall # Z-3205-2011

MANUFACTURER:  Philips Healthcare Inc., Andover, MA, by letter dated June 10, 2011.Manufacturer: Philips Medical Systems Gmbh, DMC, Development and Manufacturing Ctr., Hamburg, Germany. Firm initiated recall is ongoing.

REASON:  The mirror icon on the bottom of each image could be interpreted as a RIGHT marker for side indication if the image is mirrored again within a PACS system. This could potentially lead to a misdiagnosis.

PRODUCT:
1) Cardiovascular Custom Procedure Kits, REV OA PERFUSION W/4:1 CARDIOPLEGIA Item Number 72990. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3222-2011;2) Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2 X-COATED 8:1 FX PACK Item Number 73192. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3223-2011;3) Cardiovascular Custom Procedure Kits, Rev OA FX 8:1 PACK Item Number: 73315. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3224-2011;4) Cardiovascular Custom Procedure Kits, Rev O X-Coated 8:1 CP No OXY Item Number: 73329. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3225-2011;5) Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1 X-Coated 4:1 CP50 FX Pack Item Number: 73381. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3226-2011;6) Cardiovascular Custom Procedure Kits, REV..1 X-Coated Stand Alone Adult Pack Item Number: 73413. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3227-2011;7) Cardiovascular Custom Procedure Kits, REV.2, REV. 3 PUMP & TABLE PACK 1/4 Item Number: 71038-05 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3228-2011;8) Cardiovascular Custom Procedure Kits, REV.3, REV. 5 X-COATED 8:1 CARDIOPLEGIA Item Number: 71071-02. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3229-2011;9) Cardiovascular Custom Procedure Kits, REV.OB PERFUSION W/8:1 CARDIOPLEGIA Item Number: 71653-04. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall Z-3230-2011;10) Cardiovascular Custom Procedure Kits, REV.4, REV. 5 X-COATED NEONATAL PACK 3/16" Item Number: 72651-02. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3231-2011;11) Cardiovascular Custom Procedure Kits, REV.0, REV 1, REV 1A, REV. 2 XCoated 8:1 FX PACK Item Number: 73192. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3232-2011;12) Cardiovascular Custom Procedure Kits, REV.0 FX 8:1 PACK Item Number: 73329. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3233-2011;13) Adjustable Valve Item Number: 73631. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3234-2011;14) Cardiovascular Custom Procedure Kits, REV: 2 X-COATED 3/8 X 3/8 A-V LOOP Item Number: 73946. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3235-2011;15) Cardiovascular Custom Procedure Kits, REV: 1 X-COATED 3/8 X 1/2 A-V LOOP Item Number: 73954. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3236-2011;16) Cardiovascular Custom Procedure Kits, REV: 5 X-COATED FPS ADULT PACK Item Number: 73325. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Z-3237-2011;17) Cardiovascular Custom Procedure Kits, REV: 5 STANDARD PACK Item Number: 71701. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3238-2011;18) Cardiovascular Custom Procedure Kits, REV :10. REV 13, REV17, REV 18 FX X-Coated Perfusion Pack Item Number: 72941. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3239-2011;19) Cardiovascular Custom Procedure Kits, REV :2. REV 2A, REV: 17, REV 18 X-COATED FX PACK Item Number: 73191. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3240-2011;20) Cardiovascular Custom Procedure Kits, REV :3. REV: 4, REV: 5, REV: 6, REV:7 X-Coated 8000 FX PACK Item Number: 73252. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3241-2011;21) Cardiovascular Custom Procedure Kits, REV : 2, REV: 4 FX, CP50,CENT Pack Item Number: 73386. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3242-2011;22) Cardiovascular Custom Procedure Kits, REV : 3 General Low Prime Item Number: 73563. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall Z-3243-2011;23) Cardiovascular Custom Procedure Kits, REV: 2, REV:2A, REV: 5, REV: 7 X-Coated FX PERFUSION PK Item Number: 72941-01. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3244-2011;24) Cardiovascular Custom Procedure Kits, REV: 0, REV: 1 REV: 4, REV: 6A, REV: 6B. REV: 6C COATED FX PK Item Number: 72985-01. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3245-2011;25) Cardiovascular Custom Procedure Kits, REV: 1 REV: 1A COATED FX PK Item Number: 72985-02. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3246-2011;26) Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B X-COATED FX PK Item Number: 73191. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3247-2011;27) Cardiovascular Custom Procedure Kits, REV: 1A, REV :1 X-COATED FX PK Item Number: 73191-01 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3248-2011;28) Cardiovascular Custom Procedure Kits, REV: 8 Comprensive X-COATED 8000 FX PK Item Number: 73252. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3249-2011;29) Cardiovascular Custom Procedure Kits, REV: 4 FX, CP50 CENT. PK Item Number: 73386.  The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3250-2011;30) Cardiovascular Custom Procedure Kits, REV: 3, REV: 3A, REV:4 FX, CP50 CENT. PK Item Number: 73386-01. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3251-2011;31) Cardiovascular Custom Procedure Kits, REV: 0, REV: 2, REV: 6 X-Coated FX Perfusion Pack Item Number: 73785. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. Recall # Z-3252-2011

MANUFACTURER:  Recalling Firm: Terumo Cardiovascular Systems Corp., Ashland, MA, by telephone, fax, email and letter on August 12, 2011.Manufacturer: Alliant Enterprises LLC, Richland, MI. Firm initiated recall is ongoing.

REASON:  3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves.

PRODUCT:
1) Plum A+ Single Channel Infusion Pumps; The pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - software version 11.3 d) list 20679 - Hospira MedNet Software e) list 20792 - Driver The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+ a convenient and cost-effective infusion system. Recall # Z-3284-20112) Plum A+3 Triple Channel Infusion Pumps; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software The Plum A+3 is a dual-line triple channel volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+3 is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+3 a convenient and cost-effective infusion system. Recall # Z-3285-2011;3) Plum A+ Hyperbaric Single Channel Infusion Pumps; list 11005. Recall # Z-3286-2011

MANUFACTURER:  Recalling Firm: Hospira Inc., Lake Forest, IL, by letter dated September 16, 2011.Manufacturers: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica;Manufacturer: Hospira Inc., Morgan Hill, CA. Firm initiated recall is ongoing.|

REASON:  Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged the clamp prior to opening the cassette door, unrestricted flow may occur.

PRODUCT:
Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required. Recall # Z-0007-2012

MANUFACTURER:  B Braun Medical, Inc., Carrollton, TX, |by letter dated September 8, 2011. Firm initiated recall is on going.

REASON:  The Outlook ES Dose Guard Care Area can inadvertently be exited when the pump enters the KVO (Keep Vein Open) state. The same condition can occur when a sequence of HOLD-HOLD key strokes are performed on the pump key panel.

PRODUCT:
Impac Medical Systems Sequencer Product Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability to notify the user of actions that need to take place prior to treatment, to display reference images for set up purposed and to auto setup the machine to predefined settings. The actual settings are read from the treatment machine, via the machines communication interface, and compared to predefined values. If a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate points during the treatment, the actual delivered values are recorded to provide treatment tracking. Recall # Z-0052-2012

MANUFACTURER:  Impac Medical Systems Inc., Sunnyvale, CA, by letter on September 20, 2011. Firm initiated recall is ongoing.

REASON:  Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  October 19, 2011.

CLASS II

PRODUCT:

1) Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640. The recalled GEMINI TF16 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. Recall # Z-3199-2011;2) Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640. The recalled GEMINI TF64 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. Recall # Z-3200-2011;3) Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) #K081135. The recalled GEMINI TF Big Bore system units equipped with software version: 3.6.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. Recall # Z-3201-2011

MANUFACTURER:  Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated August 9, 2011. Firm initiated recall is ongoing.

REASON :  The firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of these PET/CT system units

PRODUCT:

1) PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 PHILIPS NM3 Monitor, English, Refurbished Part Number : U1051674 PHILIPS NM3 Monitor, English, Demo Unit Part Number: DU1051674 PHILIPS NM3 Monitor, Spanish Part Number: 1060462 PHILIPS NM3 Monitor, French Part Number: 1060458 PHILIPS NM3 Monitor, Swedish Part Number:1062860 Intended use: Cardiac output monitoring, Spirometric and carbon dioxide monitoring, and Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate. Recall # Z-3287-2011;2) FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005. Recall # Z-3288-2011

MANUFACTURER:  Respironics Novametrix, LLC, Wallingford, CT, by letter on on July 29, 2011. Firm initiated recall is ongoing.

REASON:  Pressure lines maybe occluded and display incorrect tidal volumes.

PRODUCT:

Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve. Recall # Z-0003-2012

MANUFACTURER:  Recalling Firm: Cochlear Americas Inc., Englewood CO, by letter dated September 16, 2011.Manufacturer: Cochlear Limited, Lane Cove, NSW, Australia. Firm initiated recall is ongoing.

REASON:  Cochlear implant may shut down and cease to function.

PRODUCT:

Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks. Recall # Z-0039-2012

MANUFACTURER:  Recalling Firm: Richard-Allan Scientific, Co., Kalamazoo, MI, by letter beginning August 12, 2011.Manufacturer: Microm International Gmbh, Walldorf, Germany. Firm initiated recall is ongoing.

REASON:  The firm has received two complaints of finger lacerations in operators of this device.

CLASS III

PRODUCT:

Stryker SmartPump Extension Tubing (Pneumatic tourniquet). Sterile tubing extension a) 40 ",  Part number 5920-000-005; and b) 60", Part number 5920-000-005, set, luer lock. Rx only. Optional accessories used with the Stryker SmartPump Tourniquet System. The luer locks are intended to be connected to the tourniquet pump - to fill the line - and to the cuff. The extension tubing is an optional accessory used to connect the tourniquet cuff with the pump when a longer distance between the pump and the tourniquet is desired. The extension tubing comes packaged 10 per box. Recall # Z-3274-2011

MANUFACTURER:  Stryker Instruments Div. of Stryker Corp., Portage, MI, by letter dated August 22, 2011.Manufacturer: Stryker Puerto Rico LtdArroyo, PR. Firm initiated recall is ongoing.

REASON :  The product inside the package did not match the label description. The units had quick connectors instead of luer lock connectors as stated in the label description. 

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 12, 2011.

CLASS II

PRODUCT

BD MAX DNA Extraction Kit DNA-1 (Urine/Plasma) Catalog Number 437501. Kit contains 24/2D barcode sample preparation reagent tubes ***For use with the BD MAX System *** to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. The BD MAX System automates DNA extraction and concentration. No operator intervention is necessary once the clinical sample is loaded onto the BD MAX System. The BD MAX DNA Extraction Kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis, DNA extraction and removal of inhibitors. Following cell lysis, by a combination of heat and lytic enzymes, the released nucleic acid is captured by magnetic affinity beads. The beads, with the bound nucleic acids, are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. Product Quantity Distributed (Int) 21 kits. Recall # Z-3216-2011;2) BD MAX DNA Extraction Kit DNA-2 (Whole Blood) Catalog Number 437502. Kit contains 24/2D barcode sample preparation reagent tubes *** For use with the BD MAX System ***to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. The BD MAX DNA Extraction Kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis, DNA extraction and removal of inhibitors. Following cell lysis, by a combination of heat and lytic enzymes, the released nucleic acid is captured by magnetic affinity beads. The beads, with the bound nucleic acids, are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. Product Quantity Distributed (Int) 21 kits. Recall # Z-3217-2011;3) BD MAX DNA Extraction Kit DNA-3 (Swabs in Transport Medium/UTM), Catalog Number 437503. Kit contains 24/2D barcode sample preparation reagent tubes ***For use with the BD MAX System *** to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. The BD MAX System automates DNA extraction and concentration. No operator intervention is necessary once the clinical sample is loaded onto the BD MAX System. The BD MAX DNA Extraction Kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis, DNA extraction and removal of inhibitors. Following cell lysis, by a combination of heat and lytic enzymes, the released nucleic acid is captured by magnetic affinity beads. The beads, with the bound nucleic acids, are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. Product Quantity Distributed (Int) 21 kits. Recall # Z-3218-2011;4) BD MAX RNA Extraction Kit RNA-3, Catalog Number 437506. Kit contains 24/2D barcode sample preparation reagent tubes. The BD MAX RNA Extraction Kit is used with the BD MAX System to extract RNA from viruses which maybe present in clinical specimens. Purified RNA obtained with the BD MAX System or another commercially available system for reverse transcription followed by nucleic acid amplification and detection. The BD MAX RNA Extraction Kit has not been validated for use with any specific analytical test method. The BD MAX DNA extraction kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. Recall # Z-3219-2011;5) BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use, For use with the BD MAX system.The Sample Preparation Reagent kit consists of 24 (2 x 12) 2D barcode tubes which verifies against the number entered in the worklist with the handheld barcode reader. The BD MAX System is a qualitative in vitro diagnostic test obtained from vaginal and rectal swab specimens from antepartum pregnant women designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to 18 hours. The BD MAX DNA extraction kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. Recall # Z-3220-2011

MANUFACTURER

Recalling Firm: Becton Dickinson & Co, BD Diagnostic Systems, Sparksm, MD, by letter dated May 2011.Manufacturer: Handylab, Inc, |Ann Arbor, MI. Firm initiated recall is complete.

REASON:  Medical device bar code reader does not function as intended and could result in associating clinical test results to wrong patient.

PRODUCT:

ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF 10709105, STERILE. Recall # Z-3259-2011

MANUFACTURER

Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letter dated June 7, 2011.Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.

REASON:  The lot of Soft-Vu Catheters was labeled 90 cm in length; however the product was cut to a 65 cm length.

PRODUCT: 

1) Angiodynamics Profiler Balloon Dilatation Catheter, Catalog No./REF 16801101, Balloon Diameter 4MM, Balloon Length 2 CM, Catheter Length 40 CM, Sterile, Cardiovascular catheterization. Recall # Z-3261-2011; 2) Angiodynamics Profiler Balloon Dilatation Catheter, Catalog No./REF 16801105, Balloon Diameter 5MM, Balloon Length 4 CM, Catheter Length 40 CM, Sterile, Cardiovascular catheterization. Recall # Z-3262-2011

MANUFACTURER:  Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letter dated February 25, 2011.Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.

REASON:  The particular lots of Profiler PTA Balloon Catheters were labeled incorrectly. Lot 532109 contains product that is actually 5 mm x 4 cm x 40 cm and Lot 532794 contains product that is actually 4 mm x 2 cm x 40 cm.

PRODUCT:

Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. Model numbers: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440. Brand names: Powerheart AED, G3, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED. Recall # Z-3265-2011;

MANUFACTURER:  Recalling Firm: Cardiac Science Corp., Bothell, WA, by letter on August 1, 2011.Manufacturer: Cardiac Science Corp., Deerfield, WI. Firm initiated recall is ongoing.

REASON:  Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self test errors cause the device to enter into a service required state. CSC remind owners/operators of the Powerheart AED devices to verify the "Rescue Readiness" of their equipment and follow maintenance procedures as specified in operation and maintenance guides provided with every AED.

PRODUCT:

Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood. 9545C, 9677, 9678, 9679, 9680, 7151G, 7190, 7183, 9615, 7393, 9591, 9591A, 9579, 1802, 6181, 7070A, 9725, 9507C, and 9578. Contour 125 Count Bonus Pack (includes 2-50 Count and 1-25 Count Vials). Recall # Z-3268-2011

MANUFACTURER:  Bayer Healthcare, LLC, Mishawaka, IN, by letter dated August 12, 2011. Firm initiated recall is ongoing.

REASON:  All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour" USB blood glucose meters are being recalled a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of US FDA-cleared performance specifications and produce a low-bias reading during blood glucose testing.

PRODUCT:

Comprehensive Reverse Humeral Fracture Inserter REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter Qty 1. Instrument that is attached to the trial prosthesis for placement in the prepared bone canal to check for correct sizing, version and humeral length. Also used to insert the humeral implant into the canal. a) Part numbers: 406993; and b) 406993-00. Recall # Z-3289-2011

MANUFACTURER:  Biomet, Inc., Warsaw, IN, by August 3, 2011. Firm initiated recall is ongoing.

REASON:  Recall initiated in response to a Biomet Canada report, which noted that while testing the instruments, the pin used to secure the implant on the device did not engage on the effected lots and were distributed.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  October 5, 2011.

CLASS II

PRODUCT:

Siemens Axiom Artis U mobile x-ray system Product Usage: Mobile x-ray system.
Model number 10094012; Model number 7008530. Recall # Z-3009-2011

MANUFACTURER:  Siemens Medical Solutions USA, Inc., Malvern, PA, by letters dated June 13, 2011. Firm initiated recall is ongoing.

REASON:  When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube may be autoprotected when it reaches its temperature limitation causing the X-Ray to lock until the tube cools down. Following a tube auto-protection, an error message "Door is Open" or "Err 421/240: Door open/Switching tube/X-ray lock" will appear.

PRODUCT:

OPMI Pentero, OPMI Pentero C, OPMI Pentero 900, OPMI Vario/S8, OPMI Vario/S88, OPMI Neuro Multivision/NC4, OPMI Vario/NC33, OPMI Neuro/NC4, OPMI Neuro/NC4 Ceiling Mount. A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area. Recall # Z-3275-2011

MANUFACTURER:  Recalling Firm: Carl Zeiss Meditec, Inc., Dublin, CA, letter dated September 7, 2011.Manufacturer: Carl Zeiss, Oberkochen, Germany. Firm Initiated recall is ongoing.

REASON:  Some third party surgical drapes have optically active protective lenses that could affect the ZEISS surgical microscope position information that is passed on to third party navigation systems.

PRODUCT:

Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quantitation of alkaline phosphatase in human serum or plasma. Recall # Z-3278-2011

MANUFACTURER:  Abbott Laboratories, Inc., Irving, TX, by letter on August 26, 2011. Firm initiated recall is ongoing.

REASON:  The reagent has the potential to be contaminated with mold, the Cladosporium fungal species.

PRODUCT:

The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty. The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis,protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use. Part 00-6202-052-21. Recall # Z-3279-2011

MANUFACTURER:  Zimmer Inc., Warsaw, IN, by letter dated July 27, 2011. Firm initiated recall is ongoing.

REASON:  Product may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically, devices in the affected lot may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell. The groove provides the locking ring room to displace when inserting a liner into the shell. There has been one reported incident where the surgeon was unable to lock the liner into the shell because the locking ring groove was too shallow. Investigation revealed that there may be other shells from the same part/lot combination that have the same manufacturing non conformance.

PRODUCT

Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch Fixed Wheels, Model Numbers: 6240-5F and 6240-JR5F. The recalled product is packaged four (4) units per shipping box. Product Usage: The walkers are intended for people who need additional support to maintain balance or stability while walking. Recall # Z-3280-2011

MANUFACTURER:  Recalling Firm: Invacare Corp., Elyria, OH, by letter dated April 7, 2011Manufacturer: Hebei HealthPlus Medical Device Co, LTD, Handan City, China. Firm initiated recall is ongoing.

REASON: The firm is conducting a recall/correction of their adult and junior wheeled walkers due to a component defect. The firm determined that the caster bolt on the wheeled extension was too short to adequately maintain the Nylex fastener. Consequently, over time, this condition incurs the potential for the caster to loosen and detach, causing the wheels to fall off the walker. This scenario would result in instability of the product and poses the potential for serious injury to the user in the event of a fall.

PRODUCT:

ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software module that provides supplemental information to those images extracted from CT and MR temporal datasets. Recall # Z-3282-2011

MANUFACTURER:  Recalling Firm: GE Healthcare, LLC, Waukesha, WI, byletters dated August 18, 2011.Manufacturer: GE Medical Systems, SCS, Buc Cedex, France, Firm initiated recall is ongoing.

REASON:  GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor/FiberTrak protocol on Advantage Workstation may not match with the orientation annotations displayed in the viewport. This issue may impact patient safety.

PRODUCT:  Boston Scientific, LATITUDE Patient Management System Communicator, Model 6476, Boston Scientific, LATITUDE RF Communicator & Software, Model 6482. LATITUDE Communicator REF 6468 (only distributed outside the US) The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. Recall # Z-3283-2011

MANUFACTURER:  Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN, by letter dated August 2011.Manufacturers: Benchmark Electronics Inc, Winona, MN;

Plexus Manufacturing Sdn. Bhd., Penang, Malaysia. Firm initiated recall is ongoing.

REASON:  A limited number of Model 6476, 6482, and 6468 (Not available in the US) LATITUDE Communicators are unable to authenticate, and thus cannot connect to the LATITUDE System. Customers are instead receiving Latitude Temporarily Unavailable (LTU) message

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  September 28, 2011.

CLASS II

PRODUCT:

Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems. Aesculap AG. Intended to replace a hip joint. Part Numbers: NC077K, NC078K, NC079K, NC087K, NC088K, NC089K, NC097K, NC098K, and NC099K). Recall # Z-3014-2011

MANUFACTURER:  Recalling Firm: Aesculap Inc., Center Valley, PA, by letter dated July 19, 2011.Manufacturer: Aesculap AG, Tuttlingen, Germany. Firm initiated recall is ongoing.

REASON:  Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter.

PRODUCT:

Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum. Part number GM11002420; (part of Segmented Cyclinder Set, GM11004150). Recall # Z-3055-2011

MANUFACTURER:  Recalling Firm: Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated July 13, 2011.Manufacturer: Varian Medical Systems Haan, Haan, Germany. Firm initiated recall is ongoing.

REASON:  Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error.

PRODUCT:

Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket. Recall # Z-3119-2011

MANUFACTURER:  Cincinnati Sub-Zero Products Inc., Cincinnati, OH, by letter dated July 27, 2011. Firm initiated recall is ongoing.

REASON:  Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations.

PRODUCT

VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for the detection of Chlamydia antigen in endocervical or urethral specimens, using the ELFA technique (Enzyme Linked Fluorescent Assay. Catalog number: 30101-01. Recall # Z-3129-2011

MANUFACTURER:  Recalling Firm: BioMerieux, Inc., Durham, SC, by letter dated July 8, 2011.Manufacturer: BioMerieux Vitek Inc., Lyon, France. Firm initiated recall is ongoing.

REASON:  Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients.

PRODUCT:

Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case. Recall # Z-3172-2011

MANUFACTURER:  Medela Inc., McHenry, IL, by letter dated July 26, 2011. FDA initiated recall is ongoing.

REASON:  Some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set, Tier I, 10 MM Flat Drain", were labeled incorrectly as "0877067 Wound Dressing Set, Tier III 15 Fr Round Channel Drain". The outside label on the case is correctly labeled as "0877061 Wound Dressing Set, Tier 1,10 MM Flat Drain".

PRODUCT

Terumo Sarns Level Sensor II Pads. Used to attach level sensors to the sides of the venous reservoir. Product code: 195240, Batch Numbers 616814, 618558, 619369, and 619396. Recall # Z-3176-2011

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated August 10, 2011. Firm initiated recall is ongoing.

REASON:  Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case.

PRODUCT:

1) TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed X-Ray Tomography. Recall # Z-3195-2011;2) TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed X-Ray Tomography. Recall # Z-3196-2011;3) TSX-201A: AQUlLlON LB; System, X-Ray, Tomography, Computed X-Ray Tomography. Recall # Z-3197-2011;4) TSX-101A: AQUILION 16; System, X-Ray, Tomography, Computed X-Ray Tomography. Recall # Z-3198-2011

MANUFACTURER:  Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter dated June 22, 2011.Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.

REASON:  Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON LB; System, X-Ray, Tomography, Computed, and TSX-1O1A: AQUILION 16; System, X-Ray, Tomography, Computed due to several software issues that cause the scanners to function incorrectly.

PRODUCT:

Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500 (GE Healthcare). Recall # Z-3206-2011

MANUFACTURER:  Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated March 30, 2011.Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.

REASON:  The plastic enclosure on the external power supply of the TruSat Pulse Oximeter is prone to breakage, and overheating. The issue may impact patient or user safety.

PRODUCT:

Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Recall # Z-3207-2011

MANUFACTURER:  Synthes USA (HQ), Inc., West Chester, PA, by letter on March 11, 2011. Firm initiated recall is ongoing.

REASON:  Labeling Correction -- The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant prolongation of OR time.

PRODUCT:

1) DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only Sterile EO, USA Circumcision Clamp. Recall # Z-3253-2011;2) Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only Sterile EO; Made in Dominican Republic (2) DeRoyal (R) ST. Circumcision Pack 1.3 Clamp, REF 89-5699, 1 Per Pack, Rx Only Sterile EO, Circumcision Clamp. Recall # Z-3254-2011

MANUFACTURER:  DeRoyal Industries, Inc., La Follette, TN, by letter dated May 5, 2011 and July 26, 2o11. Firm initiated recall is ongoing.

REASON:  The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design.

CLASS III

PRODUCT:

Variant II Turbo Link Hemoglobin A1c Program Reorder Pack. Catalog Number: 270-2716; Calibrator/Diluent Set. IVD. Kit components: Elution Buffer A, 2 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL Cartridge Set, 2 Cation exchange Analytical Cartridges, 4 Cation Guard Cartridges; CD-ROM - Calibration/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL, deionized water Whole Blood Primer, 6 x 1 mL Sample Vials, 2 x 100 Instruction Manual. Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (H LPC). Recall # Z-3159-2011

MANUFACTURER:  Bio-Rad Laboratories, Inc., Hercules, CA, by letter dated July 28, 2011. Firm initiated recall is ongoing.

REASON:  The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle.

PRODUCT:

Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002; UPN M00550020, STERILE EO The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope. Recall # Z-3215-2011

MANUFACTURER:  Boston Scientific Corp., Marlborough, MA, by letter dated August 11, 2010. Firm initiated recall is ongoing.

REASON:  The firm has determined that a single lot of 25 ga Expect EUS/FNA devices were mislabeled. The carton label incorrectly described the devices as 22 ga. The inner pouch label incorrectly describes the device as 25 ga.

Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  September 21, 2011

CLASS II

PRODUCT:

Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. Recall # Z-2958-2011

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on July 22, 2011, and by letter dated July 25, 2011.Manufacturer: Baxter Healthcare SA, Singapore, Singapore. FDA initiated recall is ongoing.

REASON:  Baxter's Service Center tested and returned to the user the Colleague infusion pump that did not meet PSIG (Pounds-force per Square Inch) specifications.

PRODUCT:

Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems, Inc. Oncology Systems Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions in the body where radiation treatment is indicated. Recall # Recall # Z-2978-2011

MANUFACTURER: Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated May 26, 2011. Firm initiated recall is ongoing.  

REASON:  On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions.

PRODUCT:

Symbia Radiation Therapy Pallet. An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed Tomography System. This specialty pallet is used for performing SPECT and/or SPECT/CT Scans on oncology patients with the goal of fusing the SPECT and/or SPECT/CT data with CT simulation data for planning radiation therapy. The pallet attaches to the patient beds carbon fiber pallet. Material number 10412621. Recall # Z-2980-2011

MANUFACTURER: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letter dated June 06, 2011. Firm initiated recall is ongoing.

REASON:  There a potential patient safety issue when using the Symbia Radiation Therapy Pallet. When a patient is not iso-centered before starting a scan with the Symbia T Series Systems and a non-circular orbit is selected, it is possible that one of the detectors may come into contact with the patient.

PRODUCT:

GYNDisposables Inc, IUD Insertion Kit 935K, Sterile, Single Use, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, Sterile EO, REF 935K, qty 1, Intended for intrauterine device (IUD) insertion. Recall # Z-3025-2011

MANUFACTURER: Recalling Firm: GYN Disposables Inc., Memphis, TN, by letter dated July 29, 2011.  Manufacturer: B. Braun Medical, Inc., Allentown, PA. Firm initiated recall is ongoing.

REASON:  Lack of sterility assurance.

PRODUCT:

ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; list 3L53-25 The ARCHITECT C-Peptide assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System. The ARCHITECT C-Peptide assay is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. Recall # Z-3031-2011

MANUFACTURER: Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter dated July 11, 2011.Manufacturer: Biokit Sa, Llica d'Amunt, Spain. Firm initiated recall is ongoing.

REASON:  C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls.

PRODUCT:

1) MagNA Pure LC 1.0 (software version 3.0.11). An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes. Series 1.0 software version 3.0.11, Part number 12236931001. Recall # Z-3077-2011;2) MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24). An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes. Part number 05197686001. Recall # Z-3078-2011

MANUFACTURER: Roche Diagnostics Operations, Inc., Indianapolis, IN, letter dated July 21, 2011. Firm initiated recall is ongoing.

REASON:  Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0 (software versions 1.1.23 and 1.1.24) instruments. Under certain circumstances, only a fraction of each sample is processed which may lead to false negative results, and an impact to patient health if used in a homebrew diagnostic application.

PRODUCT:

HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003. The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan. Recall # Z-3108-2011

MANUFACTURER: Accuray Inc., Madison, WI, by letter dated July 13, 2011. Firm initiated recall is ongoing.

REASON:  During DICOM export of plan level images with a non square exported Field of View (FOV), an anomaly in the process of squaring the plan level image may cause the image to shift with respect to ROIs and dose. When the anomaly occurs, the magnitude of the image shift can be a full IEC-X voxel, a full IEC-Z voxel, or full voxels in both IEC-X and IEC-Z. Please note that while square images are required for successfully importing via DICOM, the process of inserting the couch and moving the patient with the couch can result in non square images internal to TomoTherapy. Even when a plan level image is exported with non square FOV, the anomaly does not occur with every export and is dependent on specific image dimensions and voxel sizes.

PRODUCT:

Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments such as forceps and clamps, theatre shoes and other similar and related articles found in healthcare facilities. Recall # Z-3118-2011

MANUFACTURER: Recalling Firm: Steris Corp., Mentor, OH, by letter dated May 9, 2011. Manufacturer: Steris Canada, Beauport, Canada. Firm initiated recall is ongoing.

REASON:  STERIS learned that Vision SC Washer users were experiencing nuisance alarms and/or aborted cycles that are adversely affecting the reliability and operation of their unit.

PRODUCT:

Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Designed to reduce kyphosis that results from vertebral body collapse due to osteoporosis. Recall # Z-3175-2011

MANUFACTURER: Medtronic Spine LLC, formerly Kyphon Inc., Sunnyvale, CA, by letter on March 23, 2011. Firm initiated recall is ongoing.

REASON:  Device was shipped past the labeled expiration date.

PRODUCT:

STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequency energy during cardiac ablation procedures. Stockert 70 in foreign countries is also known as: EP-Shuttle/Stockert J50/Stockert J70 With software versions: 1.035/1.035J/1.035J70 to 1.037/1.037J70. Recall # Z-3178-2011

MANUFACTURER: Recalling Firm: Biosense Webster, Inc., Irwindale, CA, by letters on July 8, 2011 and July 11, 2011.Manufacturer: Stockert Gmbh, Freiburg Im Breisgau, Germany. Firm initiated recall is ongoing.

REASON:  Biosense Webster has initiated a voluntary field notification to all customers that have a Stockert 70 Radio Frequency Generator, to communicate undetected software anomalies in the form of software release note in order to amend the labeling and thereby enhance the safety of the product.

PRODUCT:

Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers: H14, H18, H27, H29, HCX; part of the Trilogy Radiotherapy Delivery System. Recall # Z-3204-2011

MANUFACTURER: Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on March 17, 2011. Firm initiated recall is ongoing.

REASON:  An improperly installed collimator cover may detach and fall from the machine, potentially striking the patient or nearby personnel.

PRODUCT:

1) Victory 10, 3 Wheel (SC610) Mobility medical devices. Recall # Z-3211-2011

2) Victory 10, 4 Wheel (SC710) Mobility medical devices. Recall # Z-3212-2011

MANUFACTURER: Recalling Firm: Pride Mobility Products Corp., Exeter, PA, by letter dated June 2011.  

Manufacturer: Melton Industrial Co., ltd., New City Science Ind., Dong Guan City, China. Firm initiated recall is ongoing.

REASON:  Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.

PRODUCT:

Sarns 8000 Cardioplegia Monitor, a) Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, b) Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit. Recall # Z-3214-2011

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated August 29, 2011. Firm initiated recall is ongoing.

REASON:  The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.

PRODUCT

1) 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83724, Description: 1304-7-25-M-TH. A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label. Recall # Z-3255-2011;2) 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83725, Description: 1304-7-25-L-TH. A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label. Recall # Z-3256-2011;3) 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726, Description: 1304-7-25-XL-TH. A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label. Recall # Z-3257-2011

MANUFACTURER: Recalling Firm: St Jude Medical, Saint Paul, MN, by letter dated February 22, 2011.Manufacturer: St Jude Medical Co., Irvine, CA. Firm initiated recall is ongoing.

REASON:  The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the incorrect Instructions for Use (IFU). To ensure accuracy of device labeling, St. Jude Medical is requesting that the incorrect IFU be replaced with the enclose, correct version.

CLASS III

PRODUCT:

BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally implantable vascular access device designed to provide long term repeated access to the vascular system. Prod Number: 0602290. Recall # Z-3173-2011

MANUFACTURER: Recalling Firm: Bard Access Systems, Salt Lake City, UT, by letter dated August 30, 2011.Manufacturer: Bard Reynosa S.A. De C.V., Tamaulipas, Mexico. Firm initiated recall is ongoing.

REASON:  Implanted port has discrepant product information on package labeling.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 14, 2011.

CLASS II

PRODUCT:

HOLDEX Single-Use Holder PP closed pack. A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless steel needle on the underside of the holder, recommended for use with commercially available butterfly and luer needles in routine venipuncture procedures. Item number: 450263D. Recall # Z-2957-2011

MANUFACTURER: Recalling Firm: Greiner Bio-One North America, Inc., Monroe, NC, by letter dated June 29, 2011.Manufacturer: Greiner Bio-One Gmbh, Kremsmunster, Austria. Firm initiated recall is ongoing.

REASON:  At removal of the tube from the holder, the needle may dislodge and blood spill can occur.

PRODUCT:

Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System. A non-invasive, non-contact OLCR (Optical Low Coherence Reflectometer) Biometer used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of IOL (Intraocular Lens) for implantation after removal of the natural crystalline lens following cataract removal. Part Number 7220162. Recall # Z-2964-2011

MANUFACTURER: Recalling Firm: Haag-Streit USA Inc., Mason, OH, by letter dated June 20, 2011. Manufacturer: Haag Streit Ag, Koeniz, Switzerland. Firm initiated recall is ongoing.

REASON: A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000.

PRODUCT:

1) Infinity Delta Portable Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Catalog Number(s): MS18597/MS18852. Recall # Z-3047-2011;2) Infinity Gamma X XL Portable Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Catalog Number(s): MS18597/MS18852. Recall # Z-3048-2011

MANUFACTURER: Draeger Medical Systems, Inc., Telford, PA, by letters dated July 2011. Firm initiated recall is ongoing.

REASON: Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.

PRODUCT:

"BIO-RAD***Kallestad Mouse Stomach/Kidney 8 Well Slides*** STORE FROZEN***" The test kit contains slides and substrate. For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies. MSK catalog number: 30443. Recall # Z-3051-2011

MANUFACTURER: Bio-Rad Laboratories, Redmond, WA, by telephone on June 30, 2010 and July 13, 2010. Firm initiated recall is complete.

REASON: KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.

PRODUCT:

High-Definition 120 Multileaf Collimator HD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape s-ray field perimeter. Field shape can be either static (fixed) or dynamic. The intended use is to assist clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. Model Numbers: H56, HHM. Recall # Z-3052-2011

MANUFACTURER: Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated June 6, 2011. Firm initiated recall is ongoing.

REASON: When using the HD120 Multi Leaf Collimator for beam shaping, and under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose.

PRODUCT:

Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers. Catalog number SIM-220A. Recall # Z-3063-2011

MANUFACTURER: Recalling Firm: Sysmex America, Inc., Mundelein, IL, by letter dated April 2011.

Manufacturer: Sysmex Reagents America Inc., Mundelein, IL. Firm initiated recall is ongoing.

REASON: The affected lots of Stromatolyser-IM lysing reagent were found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false "Platelet Clump" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.

PRODUCT:

Model 754/754M Disposable. Accessory for 700 Series 754/754m Ventilators during MRI examinations. Catalog/Code # 820-0092-00. Recall # Z-3080-2011.

MANUFACTURER: Impact Instrumentation, Inc., West Caldwell, NJ, by letter dated May 27, 2011. Firm initiated recall is ongoing.

REASON: Circuits are being distributed without market clearence (510k).

PRODUCT:

1) Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110, packaged 6 units/case, RX, Sterile. For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery. Recall # Z-3087-2011;2) Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, packaged 6 units/case, RX, Sterile. For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery. Recall # Z-3088-2011;3) Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile. For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery. Recall # Z-3089-2011;4) Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Ref: BL5114, packaged 6 units/case, RX, Sterile. For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery. Recall # Z-3090-2011

MANUFACTURER: Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by telephone and FAX or e-mail dated July 27, 2011.Manufacturer: Bausch & Lomb Inc. Saint Louis, MO. Firm initiated recall is ongoing.

REASON: The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction

PRODUCT:

1) Encision AEM Suction Irrigation Electrode, L-Diamond, REF ES3881. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. Recall # Z-3093-2011;2) Encision AEM Suction Irrigation Electrode, Spatula, REF ES3882. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. Recall # Z-3094-2011;3) Encision AEM Suction Irrigation Electrode, L-Hook, Catalog: REF ES3883. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. Recall # Z-3095-2011;4) Encision AEM Suction Irrigation Electrode, J-Hook, Catalog: REF ES3884. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. Recall # Z-3096-2011;5) Encision AEM Suction Irrigation Electrode, Needle Tip, Catalog: REF ES3885. Recall # Z-3097-2011

MANUFACTURER: Encision, Inc., Boulder, CO, by letter dated August 24, 2011. Firm initiated recall is ongoing.

REASON: Electrode tips have been reported breaking off during use or cleaning.

PRODUCT:

BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Used to plan radiotherapy treatments for patients with malignant or benign diseases. In addition, the module is specifically indicated for planning proton treatment of neoplasms of the eye. Recall # Z-3103-2011

MANUFACTURER: Varian Medical Systems, Inc., Charlottesville, VA, by letter dated August 05, 2010. Firm initiated recall is complete

REASON: Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan.

PRODUCT:

Varian Treatment version 6.6.5052. Intended to provide accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device form commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan. Model H48. Recall # Z-3105-2011

MANUFACTURER: Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters dated July 20, 2011. Firm initiated recall is ongoing.

REASON: Potential for Varian Treatment application failing to load the physical wedge filter for a treatment field on a Siemens Mevatron linear accelerator. Delivery of a treatment field without the planned wedge would deliver more dose than intended and would change the shape of the dose distribution for that field.

PRODUCT:

DrugCheck. Following cup Model numbers involved in the recall: 60670, 60700, 60713, 60717, 60870, 60923, 61012, 61019, 61023, 61024, 61040, 61042, 61057, 61102, 61105, 61203, 61204, 61206, 61208, 61301, 61303, 61401, 70603, 70809, 71032, 71043, 71055, 71065, 71202, 71204, 71205, 71401, 71402, 60718-3, 60720-6, 60925-A, 60927-3, 60930-A, 60980-3A, 61002-3, 61010-4, 61023-A, 61028-3A, 61039-4, 61040-A, 61055-A, 61056-3, 61057-6, 61100-3, 61102-3,61104-3,61105-5 CRL,61120-3,61202-4,61204-4,61204-A,61206-3A,61207-4,61302-3, 61303-A, 61401-A, 70660-3, 70716-3, 71045-A, 71055-6, 71102-3A, 71204-4, 71206-3A. In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine. Recall # Z-3113-2011

MANUFACTURER: Express Diagnostics Int'l., Inc., Blue Earth, MN, by letter dated October 4, 2010. Firm initiated recall is ongoing.

REASON: Express Diagnostics Int'l, Inc (EDI), is recalling DrugCheck Drug Screen Cups containing buprenorphine (BUP) and propoxyphene (PPX) because they must be labeled as "forensic use only", meaning they cannot be distributed or used for treatment or diagnostic purposed in the United States.

PRODUCT

TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2FS2. Provide mobility for physically impaired individuals. Recall # Z-3161-2011

MANUFACTURER: TiSport, Llc, Pasco , WA, by letter on July 5, 2011. Firm initiated recall is ongoing.

REASON: The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off.

CLASS III

PRODUCT:

Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10. Highland Metals, Inc. Wire used for orthodontic treatment to place in the brackets to shape teeth. Model: 001. P/N: 11219251124. Recall # Z-2963-2011

MANUFACTURER: Highland Metals, San Jose, CA, by e-mail and letter dated July 12, 2011. Firm initiated recall is ongoing.

REASON: Heat Activated Niti, Natural, Upper, 0.19 x 25" Arch wires mixed with size 021x0.25" Arch Wires.

PRODUCT:

Cell Marque antibody CD99 (H036-1.1) Mouse Monoclonal. The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician. Recall # Z-3110-2011

MANUFACTURER: Cell Marque Corp., Rocklin, CA, by telephone on July 12, 2011. Firm initiated recall is complete.

REASON: Incorrect label on product bottle, although labeling on outer box is correct.

 Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 7, 2011

PRODUCT:

Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories. Recall # 3043-2011

MANUFACTURER: Recalling Firm: Medtronic, Inc. – Neuromodulation, Minneapolis, MN, by letter beginning July 05, 2011 and by press release on July 08, 2011.Manufacturers: Medtronic Neuromodulation, Columbia Heights, MN;

Medtronic Puerto Rico Operations Co., Juncos, PR. Firm initiated recall is ongoing.

REASON:   Medtronic is updating information regarding the potential for reduced battery performance that can lead to sudden loss of therapy in a small percentage of Medtronic Model 8647 SynchroMed II pumps that was communicated with Healthcare providers in July 2009. The purpose of the current communication is to provide updated information regarding the scope and occurrence of this issue and to emphasize previously communicated patient management recommendations. Medtronic is not retrieving the device from the field or recommending prophylactic replacement of the pump.

CLASS II

PRODUCT:

Intuitive Surgical da Vinci Si Surgical System (IS3000); Product Usage: Intended to assist in the accurate control of Intuitive Surgical Endoscopic Endo Wrist Instruments and Accessories. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended for use for trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. Recall # Z-2930-2011

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by letter dated July 1, 2011. Firm initiated recall is ongoing.

REASON: Potential failure of the retention component of the Master Tool Manipulator (MTM) of the Intuitive Surgical da Vinci Si Surgical System which could cause uncontrolled movement.

PRODUCT:

1) RUSCH, GB: Female Catheter, All Purpose PVC, 08 Fr. 18 cm, Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product Number: 238300080. Recall # Z-2932-2011;2) RUSCH, GB: Female Catheter, All Purpose PVC, 10 Fr. 18 cm, Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238300100,. Recall # Z-2933-2011;3) RUSCH, GB: Female Catheter, All Purpose PVC, 12 Fr. 18 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238300120. Recall # Z-2934-2011;4) RUSCH, GB: Female Catheter, All Purpose PVC, 14 Fr. 18 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238300140. Recall # Z-2935-2011;5) RUSCH, GB: Female Catheter, All Purpose PVC, 16 Fr. 18 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238300160. Recall # Z-2936-2011;6) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 10 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500100, Recall # Z-2937-2011;7) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 12 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500120, Recall # Z-2938-2011;8) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 14 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500140. Recall # Z-2939-2011;9) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 16 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500160, Recall # Z-2940-2011;10) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 18 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500180. Recall # Z-2941-2011;11) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 20 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500200. Recall # Z-2942-2011;12) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 22 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500220. Recall # Z-2943-11;13) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 40 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500240. Recall # Z-2944-2011

MANUFACTURER: Recalling Firm: Teleflex Medical, Durham, NC, by letter dated June 30, 2011. Manufacturer: Unomedical s.r.o., Michalovce, Slovakia. Firm initiated recall is ongoing.

REASON: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.

PRODUCT:

CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part *** Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may be used in procedures lasting up to 6 hours. Recall # Z-2950-2011

MANUFACTURER: Recalling Firm: Terumo Cardiovascular Corp, Elkton, MD, by letter dated July 20, 2011. Manufacturers: Terumo Cardiovascular Corp., Elkton, MD; Terumo Cardiovascular Systems Corp., Ashland, MA. Firm initiated recall is ongoing.

REASON: Reservoir blood bag used in cardiovascular procedures may leak.

PRODUCT:

a) XT125 Photopheresis Procedural Kit for use with the UVAR XTS Instrument; b) XT001 Photopheresis Procedural Kit for use with the UVAR XTS Instrument Single-use, disposable, closed system with sterile fluid pathways. The device collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythocytes to the patient. Recall # Z-2994-2011

MANUFACTURER: Therakos, Inc., Raritan, NJ, by letter dated March 31, 2011. Firm initiated recall is ongoing.

REASON: Increased complaints were received of tubing leaks at the junction between the tubing and Fluid Logic Module plastic ports of the kits.

PRODUCT:

Katzen" Infusion Wire, 0.035 in x 180 cm, UPN Product No. M001461930, RED Catalog No. 46-193, Made in USA 8600. Intended for the infusion of therapeutic agents (i.e., heparin, saline, thrombolytic agents, etc) in the peripheral vasculature. The wire allows for the delivery of agents in either a "pulse -spray" or "slow weep" technique. Recall # Z-3053-2011

MANUFACTURER: Recalling Firm: Boston Scientific Corp, Maple Grove, MN, by letter dated August 1, 2011.Manufacturer: Boston Scientific Corp, Miami, FL. Firm initiated recall is ongoing.

REASON: Boston Scientific is voluntarily recalling one lot/batch of Katzen" Infusion Wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. The labels indicate a device length of 180cm while the actual device length is 145cm.

PRODUCT:

1) Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter, Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling. Catalog number: MP-P5SAT. Recall # Z-3071-2011;2) Vortex MP Port Single Titanium Port with Attachable (5Fr) Silicone Catheter. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling. Catalog number: MP-P5SDT. Recall # Z-3072-2011;3) Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures. Catalog number: 4401. Recall # Z-3073-2011;4) Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures. Catalog number: 44011. Recall # Z-3074-2011

MANUFACTURER: Angiodynamics, Inc., Manchester, GA, by letter dated August 30, 2010. Firm initiated recall is ongoing.

REASON: The labeling contains errors which result in the products being misbranded.

PRODUCT:

GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use with GemStar Infusion Pumps; The docking station for the GemStar pump is used to provide an alternate power source, acting either as a direct current battery backup, or as an alternating current power source when the docking station is plugged into AC power. The docking station also serves as a stand in which to place the GemStar during pump operation. Recall # Z-3107-2011

MANUFACTURER: Recalling Firm: Hospira Inc., Lake Forest, IL, by letter dated August 1, 2011.Manufacturer: Hospira Inc., Morgan Hill, CA; Hospira, Inc., San Diego, CA. Firm initiated recall is ongoing.

REASON: Hospira has received reports of sparking, smoking, charring and electrical shock when using the GemStar Docking Station due to fluid ingress into the docking station.

PRODUCT:

Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209 IntelliVue Clinical Information Portfolio Release E.00 and E.01 865300 IntelliVue Clinical Information Portfolio NICU Link Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage. Recall #Z-3111-2011

MANUFACTURER: Philips Healthcare Inc., Andover, MA, letter dated July 2011. Firm initiated recall is ongoing.

REASON: Under certain circumstances, edits to an order can result in unintended scheduled interventions on the IntelliVue Clinical Information Portfolio. A patient may receive interventions or additional medication doses that are not intended.

 Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 31, 2011.

Class I

Product(s): Boston Scientific Innova Over-the-Wire Self-Expanding Stent System. 505 devices are subject to this recall.

Lot/ Serial Numbers:
14185610; 14186554; 14186392; 14212643; 14112648; 14222479; 14185609; 14186566; 14188380; 14190185; 14166907; 14208241; 14249236; 14271562; 14307650; 14312650; 14174799; 14207861; 14228329; 14175011; 14212647; 14312649; 14181569; 14201269; 14166906; 14184177; 14224203; 14231611; 14264850; 14264851; 14266959; 14270149; 14164683; 14194241; 14212645; 14218066; 14218447; 14229678; 14237239; 14245445; 14245447; 14245451; 14247059; 14197292; 14212642; 14264853; 14266955; 14266957; 14274756; 14292658; 14312539; 14166851; 14203523; 14238800; 14244222; 14247620; 14250456; 14251260; 14252968; 14301370; 14174210; 14201609; 14207860; 14264885; 14264856; 14166850; 14184178; 14222760; 14222761; 14230536; 14230537; 14230538; 14234498; 14236797; 14163858; 14186555; 14201320; 14201321; 14201606; 14209195; 14212644; 14216075; 14222762; 14166849; 14188392; 14222765; 14230539; 14230560; 14230561; 14237309; 14237310; 14238251; 14240739; 14301313; 14315579; 14318074; 14181570; 14209193; 14174794; 14204328; 14217705; 142866097; 14300372; 14307653; 14166854; 14194242; 14212103; 14212646; 14224204; 14264332; 14278123; 14279141; 14279142; 14315992; 14173148; 14204326; 14218451; 14241500; 14254515; 14297582; 14166902; 14203524; 14234815; 14252037; 14267965; 14279146; 14279147; 14307648; 14166900; 14212102; 14217146; 14278494; 14166853; 14184179; 14186567; 14229668; 14241791; 14256173; 14256174; 14256175; 14260901; 14312163; 14166852; 14186556; 14224202; 14243896; 14246803; 14246804; 14249237; 14250454; 14252035; 14296997; 4299010; 14166857; 14201607; 14201608; 14252966; 14252967; 14256375; 14279140; 14315578; 14181568; 14212649; 14250980; 14177592; 14218450; 14230566; 14174795; 14204329; 14230567; 14177585; 14207862; 14181571; 14181571; 14163857; 14184300; 14186568; 14198459; 14201266; 14201267; 14201268; 14209194; 14212641; 14214399; 14218441; 14218442; 14222767; 14222768; 14228777; 14286099; 14166856; 14190182; 14218448; 14222766; 14267441; 14267975; 14271561; 14300373; 14174209; 14204327; 14218449; 14282600; 14297398; 14185608; 14284696; 14186934; 14293503; 14190181; 14194561; 14185611; 14186553; 14187177; 14291945; 14190184; 14315577; 14187499; 14175010; 14278491; 14296355; 14181567; 14267440; 14320002; 14180942; 14214844; 14181975; 14203525; 14174200; 14289498; 14301368; 14319187; 14170917; 14247621; 14252036; 14255848; 14264852; 14267442; 14166905; 14266956; 14274757; 14289248; 14300697; 14312657; 14173640; 14263631; 14271563; 14278492; 14292561; 14292562; 14307644; 14180556; 14274013; 14300695; 14166903; 14255850; 14260681; 14260683; 14166901; 14229148; 14233623; 14233624; 14234800; 14297399; 14166909; 14243465; 14256372; 14256374; 14286202; 14293322; 14307654; 14319668; 14181976; 14250839; 14270152; 14177594; 14236053; 14177182; 14264339; 14281813; 14301369; 14312653; 14312654; 14177591; 14274012; 14279143; 14166908; 14289098; 14289099; 14289240; 14307647; 14315860; 14180946; 14266958; 14301371; 14315861; 14170918; 14270154; 14296995; 14296996; 14296998; 14166904; 14243466; 14243457; 14252033; 14252034; 14262898; 14173398; 14231610; 14267976; 14314825; 14181974; 14184301; 14186737; 14185607; 14188391; 14177596; 14260685; 14322569; 14180945; 14320003; 14193019; 14190183; 14322386; 14166859; 14229672; 14230562; 14230563; 14230564; 14230565; 14252965; 14300694; 14173399; 14278124; 14279275; 14288784; 4300374; 14177183; 14286201

MANUFACTURER:  Boston Scientific Corp., Maple Grove, MO, by letter, dated May 13, 2011. Firm initiated recall is ongoing.

REASON:  Boston Scientific Corporation is conducting a recall of the Innova Self-Expanding Stent System because they have received 6 complaints involving no deployment/partial deployment of the Innova Stent. Potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. This recall does not affect stents that have already been implanted, as the issue occurs during delivery of the stent.

CLASS II

PRODUCT:

GE Healthcare DISCOVERY Model NM/CT 670 NM/CT system. Part # 5417918-1EN. Recall # Z-2158-2011

MANUFACTURER:  GE Healthcare, LLC, Waukesha, WI, by letter on January 26, 2011. Firm initiated recall is ongoing.

REASON:  GE Healthcare has become aware of a missing laser aperture warning label (i.e. Laser Aperture - Do Not Stare into Beam) affecting certain Discovery Systems.

PRODUCT:

Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System Nuclear magnetic resonance imaging system. Model numbers: 4760265, 7104594, 7104719, 7104735, 7106425 and 7106557. Recall # Z-2786-2011

MANUFACTURER:  Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on March 31, 2001.  Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is ongoing.

REASON:  Firm has discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation.

PRODUCT:

Eclipse Treatment Planning System; Radiotherapy treatment for patients with malignant and benign diseases. Model No. H48. Recall # Z-2788-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated May 20, 2011. Firm initiated recall is ongoing.

REASON:  A software anomaly has been identified with the Eclipse Monte Carlo (eMC) algorithm where not-equidistant data points in the open beam profile used during configuration may lead to inaccurate results.

PRODUCT:

ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x and an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS. The Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Coherence RT Therapist v2.1x - Part # 10652387; Coherence RT Therapist v2.2x - Part # 10652388. Recall # Z-2789-2011

MANUFACTURER:  Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on May 5, 2011.Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.

REASON:  Potential safety issue of possible data loss for the transfer of the same patient’s treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system.

PRODUCT:

1) Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 2170-3000A; The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. System Code: 882480. Recall # Z-2867-2011;2) Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 4535-602-79781; The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. System Code: 882480. Recall # Z-2868-2011;3) Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number: 2170-3003A; The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. System Code: 882480. Recall # Z-2869-2011;4) Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number; 4535-602-79801; The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. System Code: 882480. Recall #Z-2870-2011;5) Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 2170-3002A; The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. System Code: 882480. Recall # Z-2871-20116) Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 4535-602-79811; The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. System Code: 882480. Recall # Z-2872-2011

MANUFACTURER:  Recalling Firm: Philips Medical Systems, San Jose, CA, by letter dated June 15, 2011.Philips Medical Systems (Cleveland) Inc., Cleveland, OH. Firm initiated recall is ongoing.

REASON:  The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the pallet and patient table resulting in broken finger bone.

PRODUCT:

Thinflap System Cross Drive, Self Drilling Screw, 1.5x4mm, (.059X.159") (WXL), Model #: 91-6704, Titanium***Non-Sterile Product, Qty 00001. Internal fixation screws intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. Recall # Z-2873-2011

MANUFACTURER:  Biomet Microfixation, Inc., Jacksonville, FL, by letter, email and telephone beginning May 17, 2010. Firm initiated recall is ongoing.

REASON:  Some packages are labeled as cross drive screws, but contain center drive screws.

PRODUCT:

eSwallow Multi-Program Dysphagia Therapy Test unit Intended Use: Powered Muscle Stimulator for treatment of dysphagia. Recall # Z-2880-2011

MANUFACTURER:  eSwallow USA LLC, Scottsboro, AL, letter dated June 22 2011. FDA initiated recall is ongoing.

REASON:  The firm was distributing medical devices without FDA approval.

PRODUCT:

BD BACTEC(tm) MGIT (tm) System Software, Catalog 445922. Product Usage: The BACTEC(tm) MGIT (tm) System Software is used in the MGIT 960 and MGIT 320 instruments for the rapid detection of mycobacteria from clinical specimens. In addition, an Antimicrobial/Drug Susceptibility Testing (AST or DST) system is used as a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and a tube for each drug, as well as a barcoded tube carrier that holds the set. The carrier barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. Large or small AST carrier sets can be placed in the rack. The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results. Recall # Z-2890-2011

MANUFACTURER:  Becton Dickinson & Co., BD Diagnostic Systems, Sparks, MD, by telephone on March 28, 2011 and letter on April 8, 2011. Firm initiated recall is ongoing.

REASON:  Software contained three additional set configurations which caused the system to reinitialized the AST set carrier defaults.

PRODUCT:

Aquamantys 2.3 Bipolar Sealer Model #23-113-1. Product Usage: The Aquamantys Bipolar Sealer is a sterile, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization. Recall # Z-2892-2011

MANUFACTURER:  Salient Surgical Technologies, Inc., Portsmouth, NH, by letter dated July 18, 2011. Firm initiated recall is ongoing.

REASON:  Insulating material on the shaft of the device may separate and expose the electrical conductor and result in burning the patient skin.

PRODUCT:

1) AxioBionics Wearable Therapy Upper Extremity BioSleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutaneous electrode garments for neuromuscular electrical stimulation. Catalog numbers for BioSleeve include 10200 and 10201. Catalog numbers for the BioGel Velcro Electrodes include118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, and 130. Recall # Z-2898-2011;2) AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutaneous electrode garments for neuromuscular electrical stimulation. Catalog numbers for the FreeStep Sleeves include 10000 and 10001. Catalog numbers for the BioGel Velcro Electrodes include118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, and 130. Recall # Z-2899-2011;3) AxioBionics Wearable Therapy BioShorts that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutaneous electrode garments for neuromuscular electrical stimulation. Catalog numbers for the BioShorts include 10210, Catalog numbers for the BioGel Velcro Electrodes include118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, and 130. Recall # Z-2900-2011;4) AxioBionics Wearable Therapy BioVest/Unitard that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutaneous electrode garments for neuromuscular electrical stimulation. Catalog numbers for the BioVest/Unitard: 1024. Catalog numbers for the BioGel Velcro Electrodes include118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, and 130. Recall # Z-2901-2011

MANUFACTURER:  Axiobionics, LLC, Ann Arbor, MI, by telephone, certified mail, or in person by June 10, 2011. Firm initiated recall is ongoing.

REASON:  Premature Device Failure: Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.

PRODUCT:

Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, eModel #728130, 510 (k) #K010817. Product Usage: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-2914-2011

MANUFACTURER:  Philips Medical Systems (Cleveland) Inc, Cleveland, OH, by letter dated June 1, 2011. Firm initiated recall is ongoing.

REASON:  Philips Medical Systems decided to conduct a recall/field correction of the patient support vertical brake hub component in all of their CT MX8000 Dual v. Exp Computed Tomography X-Ray System scanners due to a component defect which could cause an unexpected downward motion of the table (couch) while the patient is on the table. This event could occur because the short key connecting the vertical brake hub to the motor shaft can become disengaged due to the lack of thread locker on the set screws.

PRODUCT:

Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System. Welch Allyn Protocol, Inc. Intended for use by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors. Recall # Z-2918-2011

MANUFACTURER:  Welch Allyn Protocol, Inc., Beaverton, OR, by letter dated May 16, 2011. Firm initiated recall is ongoing.

REASON:  Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference.

PRODUCT:  XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0 The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2919-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter dated May 18, 2011. Firm initiated recall is ongoing.

REASON:  The XiO Software currently prompts for entry of CT to ED data for a studyset. No indication is given that the Electron Density data should only be used for Photon and Electron calculations and either Relative Stopping Power or Mass Density should be used for Proton calculations (depending on the algorithm).

PRODUCT:

Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvented and flexible containers. Recall # Z-2920-2011

MANUFACTURER:  Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated July 21, 2011. Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing.

REASON:  The position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.

PRODUCT:

Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR table) Allura Xper FD20- High resolution fixed-x ray Allura Xper FD20/10 Allura Xper FD20/20 Allura CV20 The Allura Xper F010, FD10/10, FD20, FD20/10 and FD20/20 Use From Labeling): is intended for use in cardiovascular and vascular X-ray imaging applications. including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral. thoracic and abdominal angiography, as well as PTCAs. stent placements, embolisations and thrombolysis. and Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and Electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Use of the Allura Xper FD Series in the OR environment is restricted; the system should only be used for minimally invasive procedures. (Endovascular). Recall # Z-2976-2011

MANUFACTURER:  Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated July 4, 2011. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.

REASON:  System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period.

PRODUCT:

DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning. a) Model number DV5HH; b) Model number DV51D-HH; c) Model number DV53-HH; d) Model number DV54D-HH; e) Model number DV55D-HH. Recall # Z-2990-2011

MANUFACTURER:  Sunrise Medical HHG Inc. dba DeVilbiss Healthcare. Somerset, PA, by letter dated March 11, 2011. Firm initiated recall is ongoing.

REASON:  Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture.

PRODUCT:

Access Immunoassay Systems Unconjugated Estriol, Part # 33570. The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems. Recall # Z-3023-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated December 8, 2009. Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.

REASON:  The recall was initiated because Beckman Coulter has confirmed customer reports that a single lot of Access Unconjugated Estriol reagent (PIN 33570) may produce suppressed patient results and an increased incidence of IND (Indeterminate) flags. These issues have been associated with reagent lot 913348. This reagent met all testing specifications prior to release.

PRODUCT:

1) PERPOS PLS, a) Catalog #'s 9045-0 1 & b) 9045-02. A sterile, medical device kit used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints.. Recall # Z-3033-2011;2) Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (a) 9045-01 and b) 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C. Recall # Z-3034-2011

MANUFACTURER:  Interventional Spine Inc., Irvine, CA, by letter dated March 15, 2011. Firm initiated recall is ongoing.

REASON:  Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. Use of this product may result in less than optimal compression leading to pseudoarthrosis, non-union or facet pain.

PRODUCT:

Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. Recall # Z-3035-2011

MANUFACTURER:  Recalling Firm: Mckesson Information Solutions LLC, Alpharetta, GA, by letter dated June 13, 2011.

Manufacturer: Mckesson Medical Imaging, Richmond British Columbia, Canada. Firm initiated recall is ongoing.

REASON:  Images for one patient may appear in the study of another patient.

PRODUCT

Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro diagnostic test intended for the quantitive determination of calcium activity in human serum, plasma and urine. Dimension(R) CA Flex(R) reagent is used on the Dimension(R) clinical chemistry system as an in vitro diagnostic test intended for the quantitative determination of calcium activity in human serum, plasma and urine. Catalog # DF23A. Recall # Z-3039-2011

MANUFACTURER:  Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated July 2011. Firm initiated recall is ongoing.

REASON:  Siemens Healthcare Diagnostic has confirmed a high frequency of "Abnormal assay" flags and imprecision. Test results across the assay range may be falsely depressed or elevated, as much as, 1.93 mg/dL at a concentration of 9.26 mg/dL.

PRODUCT:

enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. K060537 D071942. Recall # Z-3040-2011

MANUFACTURER:  Vital Signs Devices, a GE Healthcare Co., Totowa, NJ, by letters on July 30, 2011. Firm initiated recall is ongoing.

REASON:  enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer.

PRODUCT:

a) Amsco V-PRO 1 and b) Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR. The STERIS Amsco V-PRO and V-PRO 1 Plus Low Temperature Sterilizer are self-contained stand alone devices, using vaporized hydrogen peroxide as the sterilant. The sterilizer is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suitable for processing medical devices sensitive to heat and moisture. Recall # Z-3041-2011

MANUFACTURER:  Recalling Firm: Steris Corp., Mentor, OH, by lettersdated August 5, 2011.Manufacturer: Steris Mexico, Guadalupe, Mexico. Firm initiated recall is ongoing.

REASON:  STERIS learned that Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems users may experience premature wear of the vacuum pump and filtering assembly components. Users may also experience incomplete aeration of the device's chamber following a failed leak test.

PRODUCT:

Churchill Medical Latex-Free IV Start Kit Product Code: AMS-623ATLF. The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape roll, 2 gauze sponges, a 3M" Tegaderm" dressing, and a dressing change label AMS-623ATLF is a convenient kit that aids in preparing the insertion site for the start of intravenous therapy. Recall # Z-3049-2011

MANUFACTURER:  Churchill Medical Systems, Inc., Dover, NH, by letter on July 15, 2011. Firm initiated recall is ongoing.

REASON:  Outer Kit labeled expiration date longer than the expiration of the shortest expired product.

CLASS III

PRODUCT: 

D-10 Dual Program Reorder Pack; contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2. Product Usage: Short Program: D-10 Dual Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). Extended Program: The Bio-Rad D-10 Dual Program is intended for the percent determination of hemoglobins A2, F, and A1c, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad D-10 Dual Program is intended for Professional Use Only: For In-Vitro Diagnostic Use. Model number 220-0201. Recall # Z-2889-2011

MANUFACTURER:  Bio-Rad Laboratories, Inc., Hercules, CA, by letters on July 11, 2011. Firm initiated recall is ongoing.

REASON:  Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  August 24, 2011.

CLASS I

PRODUCT:

1) Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long. Part Number 804115. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment. Recall # Z-2554-2011;2) Terumo Coronary Ostia cannula, 12 Fr, 10 (25 cm) long; Part Number 804117. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment. Recall # Z-2555-2011;3) Terumo Coronary Ostia cannula, 14 Fr, 10 (25 cm) long; Part Number 804159. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment. Recall # Z-2556-2011

MANUFACTURER:  Recalling Firm: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated May 16, 2011. Manufacturer: California Medical Laboratories Inc., Costa Mesa, CA. Firm initiated recall is ongoing.

REASON:  The presence of adhesive and/or skiving of plastic material observed inside the distal tip of the cannula, which could lead to particulate and/or decrease in the internal diameter. The plastic skiving may detach and enter the patient, embolizing the coronary vasculature. The potential risk due to decrease in the internal tip diameter is inadequate delivery of cardioplegia and/or prolonged procedure due to lower flows.

CLASS II

PRODUCT:

Accolade TMZF Plus Hip Stem: a) Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5; b) Catalog #6020-3535 Accolade 132 Size 3.5; c)  Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2; d) Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3; e) Catalog #3021-0435 Accolade TMZF Hip Stem #4; f) Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4; g) Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5; h) Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300. The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. Recall # Z-2557-2011

MANUFACTURER:  Recalling Firm: Stryker Howmedica Osteonics Corp. Mahwah, NJ, by letter dated March 1, 2011.Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.

REASON:  Accolade TMZF Plus Hip Stems are being recalled due to grit blast media which was observed in the drive hole.

PRODUCT:

Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above. Allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data form a Windows-based PC and transfer the information back to the RTP system. It is intended for use in radiation treatment planning using generally accepted contouring methods. Recall # Z-2562-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter dated November 5, 2010. Firm initiated recall is ongoing.

REASON:  Focal: If a plan involving Dynamic MLC Delivery is sent from XiO to Focal and called up there in Plan Review, the angle of the gantry is set to zero for all beams. If this plan is then sent from Focal to the R&V System, the gantry angles all remain at zero which could lead to patient mistreatment.

PRODUCT:

Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2569-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter on October 27, 2010. FDA initiated recall is ongoing.

REASON:  Monaco: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero.

PRODUCT:

XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy of brachytherapy has been prescribed. Recall # Z-2582-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter in November 2010. Firm initiated recall is ongoing.

REASON:  XiO: When a new electron beam is added to a plan, the calculation Algorithm is set to Pencil Beam, and an Aperture is added to the beam, the user can select Port-Port Properties and edit the Material Thickness values. If the algorithm is then changed to Monte Carlo, the calculation will proceed and the user is not warned the Material/Thickness values just entered are not used in the dose calculation. Further, when XiO prints out the BEV of the ports, the Material/Thickness values printed on the plot are the values entered on the Port Properties page, not the values actually used in the dose calculation.

PRODUCT:

Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system. Recall # Z-2592-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter beginning on May 21, 2010. Firm initiated recall is ongoing.

REASON:  Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated the plan based only on the isodose display, they might misinterpret the actual dose delivered to the patient.

PRODUCT:

XiO Radiation Treatment Planning System, XiO Release 2.1.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2593-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter beginning on May 27, 2010. Firm initiated recall is ongoing.

REASON:  XiO Software: The Patient Scan position is being confused with the treatment orientation of the patient. The Patient Scan position is determined from the data entered in PFM. Subsequently, when a New Teletherapy Plan is created for a patient in Teletherapy, the user is prompted with Head/Foot Gantry on the text page. This prompt is asking for the orientation of the patient when they are treated. The Setup Reference Definition index in XiO displays only the Patient Scan position.

PRODUCT:

XiO Radiation Treatment Planning System, XiO Release 4.0.2 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2595-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter beginning on May 28, 2010. Firm initiated recall is ongoing.

REASON:  XiO Software: when Digitally Reconstructed Radiographs (DRRs) are generated in XiO, and DICOM is used to export the DRRs (File-Print-DRR), the exported images are associated with the Beams, but NOT the Plan. The Plan association had always been done manually by the user. This is functionality that has never been provided on XiO. The problem occurs because XiO is not storing a persistent DICOM identifier with the Plan that the DRRs can reference when exporting.

PRODUCT:

Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system. Recall # Z-2596-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter beginning on May 28, 2010. Firm initiated recall is ongoing.      

REASON:  Focal: when a plan is sent to Focal from XiO and the structure properties are edited in Focal CT Sim activity, these changes result in changes to the MLC or field size for the plan when they should not. XiO will recalculate dose when modified plan is returned to XiO however the user may not notice that it has changed form the plant they had approved earlier. Editing the structure properties (color, rendering) in Focal can cause the MLC to discard individual leaf edits that do not match the MLC contour. Editing the structure properties in Focal can also cause the collimators to also change under certain circumstances.

PRODUCT:

Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above To create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2598-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter on January 13, 2011. Firm initiated recall is ongoing.     

REASON:  Monaco: When the isocenter location is edited in the IMRT Activity screen, the shift coordinates are not updated in the IMRT Plan report.

PRODUCT :

1) Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R. Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone. REF Number 108- 1017, 1019, 1217, 1219, 1221, 1223, 1419, 1421, 1423, 1425, 1623, 1625, 1627, 1825, 1827. Recall # Z-2602-2011;2) Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R. Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone. REF Number 109-1019, 1217, 1219, 1223, 1419, 1421, 1423, 1425, 1623, 1625, 1627, 1825, 1827. Recall # Z-2603-2011

MANUFACTURER:  Ortho Development Corp, Draper, UT, by letter on May 11, 2011. Firm initiated recall is ongoing.      

REASON:  Tests on PVC packaging material resulted in alert levels for cytotoxicity.

PRODUCT:

syngo Dynamics Picture Archiving Communication System. The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation. Recall # Z-2762-2011

MANUFACTURER:  Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by letter on May 10, 2011. Firm initiated recall is ongoing.

REASON:  For systems upgraded to syngo Dynamics version 9.0, if a legacy report generated by version 3.x or earlier is opened in the version 9.0 portals, the legacy report may be deleted and replaced with a new report from the version 9.0 reporting system or a blank report.

PRODUCT: 

Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a multifunctional, universal X~ray system with remote controlled facilities. Routine examinations that can be performed with the Diagnost include: Gastro-Intestinal examination, Urograpy, Bronchography, Arthrography, Hysterography, Myelography, Lymphography, Skeletal radiography, Tomography and Venography/phlebography. Special procedures that require subtracted and non subtracted digital imaging include: Angiography, Peripheral angiography (bolus chasing) and Vascular and non~vascular interventional procedures. Recall # Z-2765-2011

MANUFACTURER:  Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter on April 18, 2011. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.

REASON:  Updated Instructions For Use: During an examination where the patient is positioned on a -rotatable- chair with knees pointed to the rear of the system, the patients lower legs or ankles may be injured/broken.

PRODUCT:

1) Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the catheter contamination guard, is packaged with these catheters. Recall # Z-2776-2011;2) Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access Systems. Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the catheter contamination guard, is packaged with these catheters. Recall # Z-2777-2011

MANUFACTURER:  Edwards Lifesciences, LLC, Draper, UT, by letter dated June 15, 2011. Firm initiated recall is ongoing.

REASON:  Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.

PRODUCT:

1) BD Vacutainer Push Button Blood Collection Set; a) REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mm Blood collection system. Recall # Z-3028-20112) BD Bactec Blood Culture Procedural Tray, Cat. Number 442805. Used in conjunction with the blood collection system. Recall # Z-3029-2011

MANUFACTURER:  Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter dated April 22, 2011. Manufacturer: Becton Dickinson Medical Systems, Sandy, UT. Firm initiated recall is ongoing.

REASON:  BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub.

CLASS III

PRODUCT:

Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Hemoglobin F & A2 Calibrator is used as in-vitro calibration material for Beta-thalassemia testing on the Tosoh G7. Part Number 020019. Recall # Z-3030-2011

MANUFACTURER:  Recalling Firm: Tosoh Bioscience Inc., Grove City, OH, by letter dated July, 25, 2011. Manufacturers: Tosoh Corp., Minato-Ku, Japan; Diesse Diagnostica Senese Srl, Monteriggioni Si, Italy. Firm initiated recall is ongoing.

REASON:  The value after reconstitution appeared to be lower than the assigned value on the label. The measured value for Lot BCAL05R was 5.3%, whereas the value on the label is 5.7%. The criteria of the value is +/- 0.3%.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  August 17, 2011.

CLASS II

PRODUCT:

Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, PARADYM DR 8550 and PARADYM VR 8250 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent, poorly tolerated sustained ventricular tachycardia (VT). Recall # Z-2609-2011

MANUFACTURER:  Recalling Firm: ela Medical Llc, Plymouth, MN, by telephone on April 27, 2011 and letter dated May 2, 2011.Manufacturer: Sorin C.R.M., srl, Saluggia, VC, Italy. Firm initiated recall is ongoing.

REASON:  The devices included an incorrect version of the Patient Booklet. The company determined that there is no risk of adverse event associated with this labeling error.

PRODUCT:

1) PERPOS PLS SYSTEM, Catalog No. 9045-01 A sterile, medical device kit. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided and other labeling, including instructions for use. Recall # Z-2718-2011;2) PERPOS PLS SYSTEM, Catalog No. 9045-02 A sterile, medical device kit. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided and other labeling, including instructions for use. Recall # Z-2719-2011

MANUFACTURER:  Interventional Spine Inc., Irvine, CA, by letter dated March 23, 2011. Firm initiated recall is ongoing.

REASON:  This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. Use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw implant.

PRODUCT:

Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO STERILE; Model numbers: a) 508-00-000 and b) 508-00-008. The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant (s), and a functional deltoid muscles is necessary to use the device. Recall # Z-2739-2011

MANUFACTURER:  Encore Medical, Lp, Austin, TX, by letter dated April 18, 2011. Firm initiated recall is ongoing.

REASON:  The device has the potential to not appropriately mate with the humeral stem.

PRODUCT:

VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular System Indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting. Recall # Z-2854-2011

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone on June 10, 2010. Firm initiated recall is complete.

REASON:  Teumo's investigation identified issues with the devices’ capability to maintain pressure within the tunnel.

PRODUCT:

PALL Medical LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE. Designed to reduce the levels of circulating leukocytes and remove microemboli greater than 40 microns in size from the perfusate during extracorporeal circulation including: gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris. Catalog/Model/Reorder Number: LGB. Recall # Z-2856-2011

MANUFACTURER:  Recalling Firm: Pall Corp., Port Washington, NY, by letter dated May 26, 2011.  Manufacturer: Pall Newquay Ltd., Cornwall, United Kingdom. Firm initiated recall is ongoing.

REASON:  Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure.

PRODUCT:

Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Transluminal Coronary Angioplasty (PTCA) and/or Percutaneous Transluminal Angioplasty (PTA). Recall # Z-2858-2011

MANUFACTURER:  Recalling Firm: Terumo Medical Corp., Elkton, MD, by letter dated June 3, 2011.Manufacturer: Ashitaka Factory of Terumo Corp., Fujinomiya City, Shizouka, Japan. Firm initiated recall is complete.

REASON:  Baloon catheter guidewires may become uncoiled during angioplasty procedures.

PRODUCT: 

Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray. The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw is designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals. Recall # Z-2859-2011

MANUFACTURER:  Mallinckrodt Inc., Cincinnati, OH, by letter dated May 20, 2011. Firm initiated recall is ongoing.

REASON:  Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101.

PRODUCT:

MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions during angiographic procedures. Recall # Z-2866-2011

MANUFACTURER:  Medrad Inc., Indianola, PA, by letter on June 2, 2011. Firm initiated recall is ongoing.

REASON:  Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection System. Upgrades were initiated in October, 2007. Observance of a possible increase in complaints and adverse event reporting resulted in the firm issuing "Important Product Use Reminder" to remind users of proper procedures for using the system and the need for diligence in reducing air embolism risks. Firm has initiated Field Corrections to upgrade existing systems.

PRODUCT:

Aplio Artida Ultrasound Diagnostic System SSH-880CV. A diagnostic ultrasound system. Recall # Z-2897-2011

MANUFACTURER:  Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter dated December 21, 2010. 

Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.

REASON:  The panel operation for the Aplio Artida may become disabled (i.e., system may hang up) when processing to display patient information (heart rate, time, VCP counter, etc).

PRODUCT:

1) remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species. Recall # Z-2928-2011;

2) remel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species. Recall # Z-2929-2011

MANUFACTURER:  Remel Inc, Lenexa, KS, by letters dated April 20, 2011 and April 25, 2011. Firm initiated recall is ongoing.

REASON:  Organism strains may fail to consistently produce confluent growth.

PRODUCT:

1) Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 40 mm, 30 degree angle. To treat cancer of the uterus, cervix, endometrium and vagina. Product number applicator Set: GM11006200; 40 mm, 30 degree angle probe product number: GM11006140. Recall # Z-2995-20112) Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 60 mm, 30 degree angle. To treat cancer of the uterus, cervix, endometrium and vagina. Product number applicator Set: GM11006200; 60 mm, 30 degree angle probe product number: GM11006160. Recall # Z-2996-2011;3) Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 80 mm, 30 degree angle. To treat cancer of the uterus, cervix, endometrium and vagina. Product number applicator Set: GM11006200; 80 mm, 30 degree angle probe product number: GM11006180. Recall # Z-2997-20114) Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 30 mm, 30 degree angle. To treat cancer of the uterus, cervix, endometrium and vagina. Product number applicator Set: GM11006200; 30 mm, 30 degree angle probe product number: GM11006130. Recall # Z-2998-2011;5) Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 50 mm, 30 degree angle. To treat cancer of the uterus, cervix, endometrium and vagina. Product number applicator Set: GM11006200; 50 mm, 30 degree angle probe product number: GM11006150. Recall # Z-2999-20116) Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 70 mm, 30 degree angle. To treat cancer of the uterus, cervix, endometrium and vagina. Product number applicator Set: GM11006200; 70 mm, 30 degree angle probe product number: GM11006170. Recall # Z-3000-2011

MANUFACTURER:  Recalling Firm: Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated July 13, 2011.   Manufacturer: Varian Medical Systems, Haan, Germany. Firm initiated recall is ongoing.

REASON:  Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.

PRODUCT:

Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate. The Officemate, FSIII and FSIIIc are compact mobile fluoroscopic C-arm systems specifically designed for x-ray imaging of extremities. The systems are used by trained medical personnel, but at times are used for non medical applications. The functionality of the units is identical for the Officemate, FSIII and FSIIIc. Also the construction of the different models is identical. That includes the mounting of the flex arm to the cabinet and the flex arm to the C-arm. The difference between the models resides in the monitors: "Officemate has one small monitor” FSIII has two larger monitors” FSIIIc is an international version of the FSIII (power kit). Recall # Z-3015-2011

MANUFACTURER:  Hologic, Inc., Bedford, MA, by letter dated July 25, 2011. Firm initiated recall is ongoing.

REASON:  The Flex arm connector to C-arm can break and the C-arm that is supported by the flex arm may fall down.

PRODUCT:

AirLife Nebulizer Heater, Catalog Code 2M8021 The AirLife Nebulizer Heater is part of the heated nebulizer system intended to provide warm bland aerosol therapy to respiratory patients. The system is used in conjunction with a standard oxygen flowmeter, which by providing pressurized oxygen powers the nebulizer creating ultra-fine particles in the therapeutic aerosol. The heater warms the solution before it reaches the aerosol jet in the nebulizer and heats the dilution air before it is entrained into the aerosol stream. An aluminum heat exchanger on the nebulizer cap transfers the thermal energy to a nebulizer solution bottle warming the solution prior to aerosolizing. Recall # Z-3016-2011

MANUFACTURER:  Recalling Firm: Carefusion 207, Inc., Palm Springs, CA, by letter dated July 15, 2011.Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is ongoing.

REASON:  the Nebulizer Heater can, over time, develop a failure mode that results in an internal electrical short. The short can result in smoke and sparks being emitted from the device. In the presence of oxygen enriched environments and a fuel source, this failure represents a potential risk of flame. CareFusion is voluntarily recalling the affected devices.

PRODUCT:

Animas 2020 Insulin Infusion Pump. Recall # Z-3017-2011

MANUFACTURER:  Animas Corp., West Chester, PA, by letter dated July, 29 20011. Firm initiated recall is ongoing.

REASON:  Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a "Replace Battery" alarm not related to the condition of the battery.

CLASS III

PRODUCT:

Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare Llc. Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxide, or nitrous oxide falls outside of defined limits. The anesthetic agent being administered is automatically identified. Recall # Z-2902-2011

MANUFACTURER:  Spacelabs Healthcare, Llc, Issaquah, WA, by letter dated June 20, 2011. Firm initiated recall is ongoing.

REASON:  Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data.

PRODUCT:

1) Bard Aspira Drainage Kit, Product Code 4991502. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites. Recall # Z-2959-2011;2) Bard Aspira Dressing Kit, Product Code 4991503. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites. Recall # Z-2960-2011;3) Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites. Recall # Z-2961-2011;4) Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant as cites. Recall # Z-2962-2011

MANUFACTURER:  Recalling Firm: Bard Access Systems, Salt Lake City, UT, by letter dated June 12, 2011.  Manufacturer: Bard Reynosa S.A. De C.V., Reynosa, Tamaulipas, Mexico. Firm initiated recall is ongoing.

REASON:  Labeling for drainage kit contained incomplete information.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  August 10, 2011.

CLASS I

PRODUCT:

Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or ventilation. Recall # Z-2848-2011

MANUFACTURER:  Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by telephone and letter beginning April 29, 2011.Manufacturer: Vital Signs Devices, a GE Healthcare Co., Totowa, NJ. Firm initiated recall is ongoing.

REASON:  The Hygroscopic Condenser Humidifier (HCH) device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.

PRODUCT:

Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemodialysis and apheresis. a) Product Number CS-15192-IXM; b) Product Number CS-15232-IXM; c) Product Number CS-15272-IXM; d) Product Number CS-15312-IXM; e) Product Number CS-15422-IX; and f) Product Number CS-15502-IX. Recall # Z-2883-2011

MANUFACTURER:  Arrow International Inc., Reading, PA, by letter dated June 28, 2011. Firm initiated recall is ongoing.

REASON:  Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters.

CLASS II

PRODUCT:

Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only: 1050-110-ENG Outside US: 1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER, 1050-240-DUT, 1050-240-FRN, 1050-240-CZE, 1050-IIO-JPN. Provides perioperative autotransfusion (salvaging and reinfusing red blood cells (RBC's) from blood shed from patients undergoing orthopedic surgery. The portable system is used in operating rooms to recycle blood lost during surgery and in the recovery room to recycle blood lost after surgery. It can be transported to the patient floor for postoperative salvage. 2 Models a) Model 1: OrthoPAT devices with no centrifuge drain spill containment system and b) Model 2: OrthoPat equipped with a spill collection drainage system. Recall # Z-2420-2011    

MANUFACTURER:  Haemonetics Corp., Braintree, MA, by letter dated April 29, 2011. Firm initiated recall is ongoing.

REASON:  2 Models a) Model 1: OrthoPAT devices with no centrifuge drain spill containment system may have potential for fluid contamination leading to potential spark or smoke may occur are recalled b) Model 2: OrthoPat equipped with a spill collection drainage system updated with revised Instructions for Use and Quick reference Guide Addendum

PRODUCT:

Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are B mode, M mode PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler) Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, RealTime Tissue Elastography, and Real Time Virtual Sonography. Recall # Z-2467-2011

MANUFACTURER:  Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter dated April 15, 2011.Manufacturer: Hitachi Medical Corp., Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.

REASON:  Software anomaly. The Doppler Trace Measurement feature on certain models of the firm's diagnostic ultrasound systems may, under certain conditions whereby multiple measurements are done sequentially, record incorrect values. The recorded value is displayed to the user on a report; however depending upon the measurement area, displayed velocity values could be lower than at the true velocity leading to the possible patient mis-diagnosis of vessel stenosis.

PRODUCT:

IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting. Recall # Z-2552-2011

MANUFACTURER:  Recalling Firm: AGFA Corp., Greenville, SC, by letter dated March 21, 2011.Manufacturer: AGFA Healthcare Corp., Westerly, RI. Firm initiated recall is ongoing.

REASON:  Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper calibration.

PRODUCT:

XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00 Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2577-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter dated April 8, 2008. Firm initiated recall is ongoing.

REASON:  XiO: When the patient is positioned with their feet toward the CT gantry, the coordinates exported to the LAB IsoMark laser positioning system are not correct. One complaint was received.

PRODUCT:

XiO Radiation treatment Planning System, XiO Release 4.2.0 and above Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2578-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter in September 2010. Firm initiated recall is ongoing.

REASON:  When a dialog box is displayed and the dose status is changed to "Dose not current", beam edits can be made in the graphics area using the mouse (rotate collimator, reposition collimator, move to center, move weight point, etc.). Then if CANCEL is selected on the dialog box, any edits made on the dialog box are undone, the dose is left unchanged, but the beam edits made in the graphics area with the mouse are kept.

PRODUCT:

1) COBAS AmpliPrep / COBAS TaqMan HCV Test, US-IVD The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C viral (HCV) RNA in human plasma or serum of HCV-infected individuals using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer for automated amplification and detection. Specimens containing HCV genotypes 1 6 have been validated for quantitation in the assay. The COBAS AmpliPrep/COBAS TaqMan HCV Test is intended for use as an aid in the management of HCV-infected individuals undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy. Recall # Z-2586-2011;2) BAS AmpliPrep / COBAS TaqMan HCV Test, CE-IVD The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C Virus (HCV) RNA in human plasma or serum using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer for automated amplification and detection. The Test is intended for use in conjunction with clinical presentation and other laboratory markers of HCV infection for the clinical management of patients with chronic HCV. Recall # Z-2587-2011

MANUFACTURER:  Roche Molecular Systems, Inc., Somerville, NJ, by letter dated April 14, 2011. Firm initiated recall is ongoing.

REASON:  The COBAS Ampliprep/COBAS TaqMan HCV Test has been shown to under-quantitate a subset of genotype 4 patient specimens by approximately 1.0-1.5 log 10 in the absence of any sequence mismatches.

PRODUCT:

1) System 1 Base 110V, Catalog 801763. MI The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional. Recall # Z-2735-2011;2) System 1 Base 220V, Catalog 801764. The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional. Recall # Z-2736-2011;3) Large Roller Pump 6" Diameter, Catalog 816571. The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional. Recall # Z-2737-2011;4) Large Roller Pump 6" Diameter, Catalog 801041. The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional. Recall # Z-2738-2011

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI, letter dated March 21, 2011. Firm initiated recall is ongoing.

REASON:  The firm has received multiple reports of the lower roller pump tube clamp mechanism failing to function in a small population of devices, making it difficult to remove or insert the tubing. If the failure occurs, the clamp dial will no longer be able to control opening/closing of the tube clamp mechanism.

PRODUCT:

1) ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018455, Size 5 1/2, Sterile. Recall # Z-2840-2011;2) ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018460, Size 6, Sterile. Recall # Z-2841-2011;3) ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018465, Size 6 1/2, Sterile. Recall # Z-2842-2011;4) ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018470, Size 7, Sterile. Recall # Z-2843-2011;5) ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018475, Size 7 1/2, Sterile. Recall # Z-2844-2011;6) ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018480, Size 8, Sterile. Recall # Z-2845-2011;7) ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018485, Size 8 1/2, Sterile. Recall # Z-2846-2011;8) ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018490, Size 9, Sterile. Recall # Z-2847-2011

MANUFACTURER:  Recalling Firm: Ansell Healthcare Products LLC, Dothan, AL, by letter dated June 9, 2011.Manufacturer: Ansell Lanka (Pvt), Ltd., Biyagama (Columbo), Sri Lanka. Firm initiated recall is ongoing.

REASON:  Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.

PRODUCT:

1) CD HORIZON (R) LEGACY (TM) FAS, REF 7542535, pedicle screw, Rx only. Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. Recall # Z-2874-2011;2) CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only. Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. Recall # Z-2875-2011;3) CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only. Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. Recall # Z-2876-2011;4) VERTEX (R), REF 69004440, cortical screw, Rx only. Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. Recall # Z-2877-2011;5) ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only. Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. Recall # Z-2878-2011

MANUFACTURER:  Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis, TN, by letter dated June 28, 2011 and by email on June 29, 2011.  Manufacturer: Medtronic Puerto Rico Operations Co., Humacao, PR. Firm initiated recall is ongoing.

REASON:  Screws are longer then size etched on the screw.

PRODUCT:

DeRoyal (R) Incision and Drainage Tray, a) RES 47-763.02, Rx Only, STERILE EO; DeRoyal (R) Incision and Drainage Tray, b) RES 47-773, Rx Only, STERILE EO, DeRoyal (R) Incision and Drainage Tray, OCEAN SPRINGS HOSP, c)RES 50-12437.08, Rx Only, STERILE EO; DeRoyal (R) Incision and Drainage Tray, ST JOSEPHS HOSPITAL, d) RES 89-6818.01, Rx Only, STERILE EO; DeRoyal (R) Universal Insertion Tray, e) RES 89-5649.01, ST FRANCIS MED CAPE GIRARDEAU, Rx Only, STERILE EO; DeRoyal (R) St. Suture Removal Kit, f) RES 32-1695, Rx Only, STERILE EO; DeRoyal (R) Stainless Suture Removal Set, g) RES 32-351, Rx Only, STERILE EO; DeRoyal (R) CRICOTHYREOTOMY AMBULANCE KIT, WISHARD MEMORIAL HOSPITAL, h) RES 89-6752.01, Rx Only, STERILE EO; DeRoyal (R) DR MATA'S PLASTIC PACK, OUR LADY OF LOURDES, i) RES 89-7212.01, Rx Only, STERILE EO; Custom Surgical kits. Recall # Z-2891-2011

MANUFACTURER:  Deroyal Industries, Inc. Lafollette, TN, by letter dated July 6, 2011. Firm initiated recall is ongoing.

REASON:  Custom surgical kits contain recalled Triad PVP prep pads.

PRODUCT:

Clinac Linear Accelerators. Radiation Therapy intended to deliver megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy. Model # H14, H27 and H29. Recall # Z-2893-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated May 24, 2011. Firm initiated recall is ongoing.

REASON:  The throat cover on the High Energy Clinac may detach if not properly installed and possibly strike a patient.

PRODUCT:

Biomet Microfixation, Center Drive Stainless Steel, 2.0MM System Screwdriver Blade***Non-Sterile Product; Blade used to implant screws.   Recall # Z-2913-2011

MANUFACTURER:  Biomet Microfixation, Inc., Jacksonville, FL, by undated letter on March 15, 2010. Firm initiated recall is ongoing.

REASON:  Product is non-conforming (blades do not retain screws).

PRODUCT:

Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530. The battery component is warranted for 5 years, and electrodes have a shelf life of 2 years. The Powerheart AED G2 and CardioVive 92530 are intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmia of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province, or country regulations in which they practice. Recall # Z-2917-2011

MANUFACTURER:  Recalling Firm: Cardiac Science Corp., Bothell, WA, by letters dated August 2010 and March 2011.Manufacturer: Cardiac Science Corp., Deerfield, WI. Firm initiated recall is ongoing.

REASON:  Cardiac Science Corporation (CSC) intent to end service support and discontinue accessory sales of Powerheart G2 Automated External Defibrillators. These models include Powerheart 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530.

PRODUCT:

Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System. Intended for use by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors. Recall # Z-2918-2011

MANUFACTURER:  Welch Allyn Protocol, Inc., Beaverton, OR, by letter dated May 16, 2011. Firm initiated recall is ongoing.

REASON:  Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference.

PRODUCT:

Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE. Indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect. a) Catalog/UPC: M0068317100, b) Catalog/UPC M0068317050. Recall # Z-2931-2011

MANUFACTURER:  Boston Scientific Corp., Marlborough, MA, by letter in May 2011. Firm initiated recall is ongoing.

REASON:  The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.

PRODUCT:

Vanguard PS Open Box Femoral 70 MM Left Interlock, "FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. A knee joint replacement prosthesis non-coated femoral indicated for cemented application only. Part # 183132. Recall # Z-2945-2011

MANUFACTURER:  Biomet, Inc., Warsaw, IN, by letter on July 6, 2011. Firm initiated recall is ongoing.

REASON:  The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.

PRODUCT:

1) BrightView X Gamma Camera, 3/8". Philips Medical Systems, Inc. intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. Model #4535-608-24741; Catalog # 882478. Recall # Z-2947-2011;2) BrightView XCT Gamma Camera, 3/8". Philips Medical Systems, Inc. intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. Model Number: 4535-604-262131. Catalog # 882482. Running system 2.0.1. Recall # Z-2948-2011;3) BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. Model Number: 4535-607-49161. Catalog # 882482. Recall # Z-2949-2011

MANUFACTURER:  Recalling Firm: Philips Medical Systems, San Jose, CA, by letter dated July 8, 2011.Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. Firm initiated recall is ongoing.

REASON:  Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly.

PRODUCT:

1) Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). A unitized microcoagulation test intended for use in performing one-stage prothrombin time. Catalogue/Code J201. Recall # Z-2953-2011;2) IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized microcoagulation test intended for use in performing one-stage prothrombin time. ID #: 6260030000. Recall # Z-2954-2011

MANUFACTURER:  Recalling Firm: International Technidyne Corp., Edison, NJ, by letters dated May 10-June 09, 2011.Manufacturer: ITC-Nexus Dx, Edison, NJ. Firm initiated recall is ongoing.

REASON:  Certain lots of Hemochron Jr. PT Cuvettes (J201) and GEM Test PT cartridges demonstrate a higher bias than historically observed when compared to laboratory reference.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 3, 2011.

CLASS I

PRODUCT:

Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the principle of counterpulsion. The IABP is placed in the descending aorta, via the Principe of counterpulsation. The IABP is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the IABP is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The CS300 has the additional capability to automatically calibrate a fiber-optic pressure sensor placed in the tip of the intra-aortic balloon. The IABP will recalibrate every 2 hours or sooner should the patient or environmental conditions change. The target populations are adult and pediatric. The IABP is intended for use in the health care facility setting. System 98 - Part Numbers 0998-00-0446-xx, 0998-UC-0446-xx; System 98XT - Part numbers 0998-00-0479-xx, 0998-UC-0479-xx ; CS100i- Part numbers 0998-UC-0446Hxx, 0998-UC-0479Hxx; CS100 - Part numbers 0998-00-3013-xx, 0998-UC-3013-xx; CS300 - Part numbers 0998-00-3023-xx, 0998-UC-3023-xx.  Recall # Z-2414-2011

MANUFACTURER:  Maquet Datascope Corp - Cardiac Assist Division, Mahwah, NJ, by letter dated March 16, 2011. Firm initiated recall is ongoing.

REASON:  Several models of the Intra-Aortic Balloon Pumps are being recalled due to a potential problem with the fan's assembly which may cause the power supply to detect an overheating event and shut down.

PRODUCT:

1) GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox 75 test iQM Part Number: 00027407508 150 test iQM Part Number: 00027415008 300 test iQM Part Number : 00027430008 450 test iQM Part Number: 00027445008 600 test iQM Part Number: 00027360008 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Recall # Z-2803-2011; 2) GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM Part Number : 00027407510 150 test iQM Part Number:00027415010 300 test iQM Part Number: 00027430010 450 test iQM Part Number: 00027445010 600 test iQM Part number: 00027360010 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Recall # Z-2804-2011 3) GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox: 75 test iQM Part Number: 00027407510 150 test iQM Part Number: 00027415010 300 test iQM Part Number: 00027430010 450 test iQM Part Number: 00027445010 600 test iQM Part number: 00027360010 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Recall # Z-2805-2011; 4) Lytes/G/L/CO-Ox/tBili : 75 test iQM Part Number:00027407511 150 test iQM Part Number: 00027415011 300 test iQM Part Number: 00027430011 450 test iQM Part Number: GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct 00027445011 600 test iQM part Number: 00027360011 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Recall # Z-2806-2011

MANUFACTURER:  Instrumentation Laboratory Co., Bedford, MA, by e-mail on May 31, 2011 and letter dated July 14, 2011. Firm initiated recall is ongoing.

REASON:  K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL.

PRODUCT:

Global Focus Marketing and Distribution, Silencer S2200 Centrifuge. Recall # Z-2857-2011

MANUFACTURER:  Global Focus Marketing & Develop, Dallas, TX, by press release on July 19, 2011 and by letters on July 15, 2011 and July 21, 2011. Firm initiated recall is ongoing.

REASON:  Potential for bucket and insert not seated on the rotor to cause the lid to break and buckets to be ejected.

CLASS II

PRODUCT:

LOGIX Order Entry (OE) Software, all versions, catalog 2M8410. The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration. Recall # Z-2291-2011

MANUFACTURER:  Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated March 29, 2011. Manufacturer: Baxter Healthcare Corp., Buffalo Grove, IL. Firm initiated recall is ongoing.

REASON:  The LOGIX OE automated backup does not retain the three most recent backup files and instead will only retain the last three backups of the previous year. The software stores backup files in numeric order rather than chronological date order.

PRODUCT:

WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and intrastromal surgery for implants. Recall # Z-2292-2011

MANUFACTURER:  WaveLight AG, Pressath, Germany, by letter April 18, 2011. Firm initiated recall is ongoing.

REASON:  The software calculating the patterns were found to have a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut in the donor or patient tissue.

PRODUCT:

Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 lbs), who require the following general types of ventilator support. Device Listing Number: D0004206. Recalling # Z-2295-2011

MANUFACTURER:  Newport Medical Instruments Inc., Costa Mesa, CA, by letter dated January 13, 2009. Firm initiated recall is ongoing.

REASON:  Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the long-term capacity of the battery.

PRODUCT:

Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 lbs). Recall # Z-2382-2011

MANUFACTURER:  Newport Medical Instruments Inc., Costa Mesa, CA, by letter dated May 14, 2010. Firm initiated recall is ongoing.

REASON:  The Newport HT50 hard shell Emergency Preparedness (EP) Storage Cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time.

PRODUCT:

Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System. Catalog Number: DC-NU-MPC Capsule Neuron" UMPC is a bedside device that enables automatic collection of vital signs data that can local cache data and connect to the hospital network through a wired Ethernet connection or via a standard 802.11 b/g/n wireless network, available in a fixed or mobile mounting option, running either DataCaptor continuous or periodic connectivity software The DataCaptor" System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor" is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to. Recall # Z-2403-2011

MANUFACTURER:  Recalling Firm: Capsule Tech Inc., Andover MA, by telephone, and email on March 23, and by letter on April 23, 2010.Manufacturer: Capsule Technologi, Paris, France. Firm initiated recall is ongoing.

REASON:  Software: Data cached on the Neuron due to server unavailability is not being delivered to the server after server availability is restored. If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes. Batteries can discharge completely in a Capsule Neuron" UMPC even though it is connected to power source.

PRODUCT:

ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impression Plus ONCOR Expression. Product Model Number ARTISTE MV System 8139789 ONCOR Avant Garde 5863472 ONCOR Impression 5857920 ONCOR Impression Plus 5857912 ONCOR Expression 7360204 and 7360717. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Recall # Z-2404-2011

MANUFACTURER:  Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter beginning on April 15, 2011.Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.

REASON:  Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment.

PRODUCT:

Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide continuous or intermittent positive pressure mechanical ventilator support for the care of individuals who require mechanical ventilation through invasive or noninvasive interfaces. Specifically, the Newport HT70 ventilator is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The ventilator is suitable Newport HT70 for use in hospital, subacute, emergency room, and home care environments as well as for transport and emergency response applications. Recall # Z-2406-2011

MANUFACTURER:  Newport Medical Instruments Inc., Costa Mesa, CA, by letter dated September 20, 2010. Firm initiated recall is ongoing.

REASON:  A limited number of power cords recently received from the supplier, Glob-Tek, have a slightly oversized plug connector which prevents the cord from locking into place. These cords are fully functional as supplied. However, the cord can be easily disconnected. If the cord is disconnected, the HT70 will alert the user with a power disconnect alarm.

PRODUCT:

XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2407-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter on May 27, 2010. Firm initiated recall is ongoing.

REASON:  XiO Software: For a specific clinical setup, the MLC leaf positions on the exported DRR images might not match the MLC leaf positions displayed in XiO. One complaint was received.

PRODUCT:

1) SureCath Set with Accessories,  Sterile EO. 28022S 1400 SureCath Set, acc CH8 Male, bulk 28023S 1400 SureCath Set, acc CH10 Male, bul 28024S 1400 SureCath Set, acc CH12 Male, bul 280320 1400 SureCath Set, acc CH14 Male 28032S 1400 SureCath Set, acc CH14 Male, bul 28036S 1400 SureCath Set, acc CH14/1,2 Male 28037S 1400 SureCath Set, acc CH16 Male 280370 1400 SureCath Set, acc CH16 Male 28033S 1400 SureCath Set, acc CH16 Male 280360 1400 SureCath Set, acc CH14/1,2 Male 280340 1400 SureCath Set w. acc FEM14` The SureCath Set is indicated for use by patients for intermittent catherization for the purpose of bladder drainage. The insertion supplies provided are to be used to insert the catheter using sterile technique. Recall # Z-2409-20112) SpeediCath, SpeediCath with Accessories, Sterile R, 1400 SpeediCath, acc CH10 Male 284831 1400 SpeediCath, acc CH12 Male 284841 1400 SpeediCath, acc CH14 Male 284851 1400 SpeediCath, acc CH16 Male 284861 1400 SpeediCath, acc CH18 Male 284811 1400 SpeediCath, acc CH8 Male 285011 1400 SpeediCath, acc CH10 Female 285021 1400 SpeediCath, acc CH12 Female 285031 1400 SpeediCath, acc CH14 Female 285041 1400 SpeediCath, acc CH16 Female 284991 1400 SpeediCath, acc CH6 Female 285001 1400 SpeediCath, acc CH8 Female The SpeediCath catheter is indicated for use by patients with chronic urine retention and patients with post void a residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The insertion supplies provided are to be used to insert the catheter using sterile technique. Recall # Z-2410-2011

MANUFACTURER:  Recalling Firm: Coloplast Manufacturing US, LL, Minneapolis, MN, by letter dated April 21, 2011.Manufacturer: Corollas A/S, Humlebaek, Denmark. Firm initiated recall is ongoing.

REASON:  Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep pads which may expire before the overall product expiration date. SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies are both packaged with a set of accessories which includes Iodine prep pads. The Iodine prep pads included in these products have their own expiration dates, which are separated from the two year shelf life of the overall product.

PRODUCT: 

DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO. Description Model # Duraspan Kit - 24cm 62152420 Duraspan Kit - 28cm 62152820 Duraspan Kit - 32cm 62153220 Duraspan Exchange Kit - 32cm 62153228 Duraspan Kit - 36cm 62153620 Duraspan Exchange Kit - 36cm 62153628 Duraspan Kit - 40cm 62154020 Duraspan Exchange Kit - 40cm 62154028 Duraspan Kit - 55cm 62155520 Duraspan Ultra Kit - 24cm 621524E0 Duraspan Ultra Kit - 28cm 621528E0 Duraspan Ultra Kit - 36cm 621536E0 Duraspan Ultra Kit - 40cm 621540E0 Duraspan Ultra Kit - 55cm 621555E0 The r4 DuraspanTM and the DuraspanTM Ultra long-term dialysis catheter are indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing. Recall # Z-2412-2011

MANUFACTURER:  Recalling Firm: R4 Vascular Inc., Maple Grove, MN, by letter dated May 3, 2011.Manufacturer: Via Biomedical, Maple Grove, MN. Firm initiated recall is ongoing.

REASON:  Over a six month period, seven patients at five hospitals experienced separation of the luer connector from the extension tube on the Duraspan catheter. Testing during failure analysis disclosed that these lots and other lots may be prone to luer separation at a low rate (<1%). The most likely clinical impact of luer separation would be the need to replace the catheter before dialysis, which could slightly delay treatment. However, in an unlikely worst case scenario, if a patient's Halkey Roberts clamp were accidentally left open or should fail, and the luer subsequently separated, the patient could experience bleeding or air embolism. If bleeding went unnoticed by the patient and others, severe injury or death could result. To date, there have not been any reported injuries.

PRODUCT:

ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum; List 6L21-25. Recall # Z-2413-2011

MANUFACTURER:  Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letters dated April 20, 2011.Manufacturer: Abbott Gmbh & Co. Kg, Wiesbaden, Germany. Firm initiated recall is ongoing.

REASON:  The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results.

PRODUCT

1) Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath. Recall # Z-2415-2011;

2) Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath. Recall # Z-2416-2011;3) Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath. Recall # Z-2417-2011

MANUFACTURER:  Terumo Medical Corp., Elkton, MD, by letter dated June 24, 2010. Firm initiated recall is complete.

REASON:  Molding defect in destination product that render the device unusable.

PRODUCT:

Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to provide continuous (endotracheal or tracheotomy [ET] tube) or non-continuous (mask) ventilator support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, emergency rooms, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility. Recall # Z-2468-2011

MANUFACTURER:  Newport Medical Instruments Inc., Costa Mesa, CA, by letter on October 27, 2009. Firm initiated recall is ongoing.

REASON:  Regarding e360 ventilators that were shipped with a different software version from what the customers ordered.

PRODUCT

MTD 4000 - Mettler Traction Decompression System, Model: ME 4000 Product Usage: Provide traction and mobilization of skeletal structures and skeletal muscles. Recall # Z-2580-2011

MANUFACTURER:  Recalling Firm: Mettler Electronics Corp., Anaheim CA, by letter dated April 14, 2011. Manufacturer: ZMI Electronics Ltd, Kaohsiung, Taiwan. Firm initiated recall is ongoing.

REASON:  The recall was initiated because Mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding Electronics Traction Device - MTD4000. The firm is initiating the recall because component failure might result in patient injury. Use of the device should cease immediately.

PRODUCT:

Cuffable Blood Pressure Cuffs; Made in Mexico. The cuff is used to determine a subject's blood pressure. 510(k) K911213 Medical Device Listing Number D110124. Recall # Z-2581-2011

MANUFACTURER:  Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated April 26, 2011.Manufacturer: Vital Signs Devices, a GE Healthcare Co, Totowa, NJ. Firm initiated recall is ongoing.

REASON:  BP cuffs may not properly inflate due to a leak.

PRODUCT:

Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00. Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system. Recall # Z-2599-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by an Advisory Notice dated February 6, 2009. Firm initiated recall is ongoing.

REASON:  Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that instead the leaves will then snap (unintentionally) back to the original aperture. Also, if the patient is sent to XiO after the MLC is edited, an isocenter shift made in XiO will also cause the MLCs to snap back to the original positions.

PRODUCT

XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above. Recall # Z-2604-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter dated May 20, 2010. Firm initiated recall is ongoing.

REASON:  XiO Software: when a treatment machine is defined in Source File Maintenance (SFM), the MLC Model is set to Elekta, and beams using this treatment machine are added to a new plan in Teletherapy, XiO automatically adds an MLC to the beam. This is because the Elekta linac will always have an MLC in place when the plan is actually delivered.

PRODUCT

1) Access Immunoassay Systems Ostase Calibrators, Part Number: 37305 The Access Ostase Calibrators are used to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphates (BAP) levels in human serum and plasma using the Access Immunoassay Systems. Recall # Z-2605-2011;2) Access Immunoassay Systems Quality Control Kits, Part Number: 37309 The Access Ostase QC is used for monitoring system performance of the Access Ostase assay. Recall # Z-2606-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on May 10, 2011.Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.

REASON:  The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials from the affected lots have shown an increased rate of fracturing and may leak the contents in the box during shipment to customers. Operator injury may occur due to contact with broken glass, exposure to infectious agents, and/or exposure by skin contact to agents that may cause sensitization. Beckman Coulter indicated there is no impact to patient results.

PRODUCT

Eon Mini Neurostimulation (IPG) System Model 3788 System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Recall # Z-2607-2011

MANUFACTURER:  Advanced Neuromodulation Systems Inc., Plano, TX, by letter dated May 24, 2011. Firm initiated recall is ongoing.

REASON:  Defective battery was identified as cause for reports of inability to communicate or recharge the product.

PRODUCT

CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where you need continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels. Recall # Z-2610-2011

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated April 28, 2011. Firm initiated recall is ongoing.

REASON:  Terumo discovered through its own testing that the presence of electromagnetic interference (EMI) in the operating room may affect the accuracy of the values displayed by the CDI"101 Hematocrit/Oxygen Saturation Monitoring System: hematocrit (HCT), hemoglobin (Hgb) and Oxygen Saturation.

PRODUCT

Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled in part: "***Pathfinder Holter Analyzer. The Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect various arrhythmias and will measure ST elevation or depression. The system acts in both a automatic mode (tape analyzed without operator intervention) and in an interactive mode; (operator can intervene and affect analysis). Recall # Z-2611-2011

MANUFACTURER:  Recalling Firm: Spacelabs Healthcare, LLC, by letter dated June 3, 2011.Manufacturer: Del Mar Reynolds Medical, Ltd., Hertford, United Kingdom. Firm initiated recall is ongoing.

REASON:  A potential hazard associated with the use of Spacelabs Healthcare Pathfinder Holter Analyzer software. The second 24 hours of a 48 hours EVO recording will not be analyzed.

PRODUCT

45cm Laparoscopic Instruments Sterilization tray. Designed to hold laparoscopic surgical manual instruments which are intended for cutting, holding, grasping and manipulating tissue, organs, organ area, surgical auxiliaries such as suturing material. The 45cm Lap tray can hold up to 11 instruments in the top tier and a combination of instruments in the bottom tier provided that the total weight of the loaded tray does not exceed 6.53 kg. Model number: 250-015-704. Recall # Z-2612-2011

MANUFACTURER:  Stryker Endoscopy, San Jose, CA, by letter dated June 8, 2011. Firm initiated recall is ongoing.

REASON:  During testing and review, Stryker Endoscopy discovered that the sterilization parameters for the 132 degree C gravity steam sterilization cycle in the IFU may not consistently sterilize all instruments in the 45cm Laparoscopic Instruments Tray.

PRODUCT:

1) Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer. Recall # Z-2613-2011;2) Cardiovascular Procedure Kit Part number 70667-01 Eisenhower Army Med Center Heart Lung Pack, Sterile. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer. Recall # Z-2614-2011;3) Cardiovascular Procedure Kit Part number 70667 Eisenhower Army Med Center Heart Lung Pack, Sterile. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer. Recall # Z-2615-2011;4) Cardiovascular Procedure Kit Part number 70367-07 Mission St. Joe's - Asheville X-Coated Low Prime Pack, Sterile. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer. Recall # Z-2616-2011;5) Cardiovascular Procedure Kit Part number 72427, Oklahoma Heart Hospital X-Coated System 1 Pack, Sterile. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer. Recall # Z-2617-2011;6) Cardiovascular Procedure Kit, Part number 65418-01, Terumo Latin America Seminsa Pediatric Sterile. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer. Recall # Z-2618-2011;7) Cardiovascular Procedure Kit, Part number 65672-01, Terumo Latin America Seminsa Lactante, Sterile. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer. Recall # Z-2619-2011;8) Cardiovascular Procedure Kit, Part number 65870, Terumo Latin America Pediatric Pack, Sterile. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer. Recall # Z-2620-2011;9) Cardiovascular Procedure Kit, Part number 65871, Terumo Latin America Lactante Pack, Sterile. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer. Recall # Z-2621-2011

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI., by letter dated May 3, 2011. Firm initiated recall is ongoing.

REASON:  The firm has received complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's manufacturing process.

PRODUCT:

Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 Used when planning and performing prostate brachytherapy implant procedure. It provides ultrasound probe alignment and radioactive seed implantation. Recall # Z-2622-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter dated December 1, 2008. Firm initiated recall is ongoing.

REASON:  Interplant Software: If the trajectory needle with a non-zero retraction is adjusted in any of the planning views (Transverse, 3D) and the program is closed and reopened, the Needle Definitions page in the Dose Plan Summary (Plan View) displays the needle with a 0.00 retraction even when the needle is displayed correctly in the planning view. If the Eliminate Leading Spacers function is applied to a needle with an adjusted trajectory, the first seed is adjusted to the 0.00 cm plane instead of adjusting the retraction to the position of the first seed.

PRODUCT:

Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital. Model Number: I0016C, I0018C, I0020C, I0022C, I0024C. Description of the product: The Coated Bio-Eye consists of a coralline hydroxyapatite sphere encased in a restorable shell that aids in implant insertion and provides a means of securing muscles to the implant. The Coated Bio-Eye Orbital Implant is indicated in orbital implantation following enucleation, or as a secondary orbital implant following extrusion, migration or rotation of primary orbital implants. It is indicated in any situation where materials such as silicone, acrylic, polyethylene or glass orbital implants would be used. Recall # Z-2624-2011

MANUFACTURER:  Integrated Orbital Implants Inc., San Diego, CA, by letter on May 20, 2011. Firm initiated recall is ongoing.

REASON:  The recall was initiated because Integrated Orbital Implants has confirmed certain lots of the Coated Bio-Eye were manufactured without expiration dating visible on the packaging. All unlabeled product is currently beyond its expiration date.

PRODUCT

1) Servo-i Ventilator Systems; Article number 64 87 800 Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory insufficiency; these are only to be used by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. These are not to be used with any anesthetic agents. Recall # Z-2628-2011;2) Servo-s Ventilator Systems; Article number 66 40 440. Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory insufficiency; these are only to be used by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. These are not to be used with any anesthetic agents. Recall # Z-2629-2011

MANUFACTURER:  Recalling Firm: Maquet Inc., Wayne, NJ, by letter dated April 20, 2011.  Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.

REASON:  Through customer complaints, Maquet has been informed that SERVO-i ventilators have stopped to ventilate and have generated three different technical error codes

PRODUCT:

Tubing Assembly #142, V2, V12 Mixer/Wash a component of the DxC instruments. Tube, Assembly, #142 V2, V12 Mixer/Wash delivers appropriate amount of wash concentrate on the UniCel DxC SYNCHRON Clinical Systems. The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent). Recall # Z-2633-2011

MANUFACTURER:  Beckman Coulter Inc., Brea, CA, by letter dated July 23, 2009. Firm initiated recall is ongoing.

REASON:  The recall was initiated because the Wash Concentrate Tube Assembly 142 may fail to deliver the appropriate amount of wash concentrate on some SYNCHRON DxC Systems due to an accumulation of crystals. The impact of this issue would include: (1) Quality Control and patient results can potentially be affected. (2) If system has been calibrating properly and Quality Control is recovering within established ranges then the instrument performance is within the limits of the product's claims.

PRODUCT

ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1 Product Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy has been prescribed. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3-dimensional radiation therapy. Recall # Z-2645-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, dated December 11, 2009. Firm initiated recall is ongoing.

REASON:  ERGO Release 1.6.3 is overestimating the MU values.

PRODUCT:

Smith & Nephew Hip Arthroscopy Repair Instrument Tray Part Number: 72202732 Device Description-The Smith & Nephew Hip Arthroscopy Repair Instrument Tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process. The instrument tray is a perforated stainless steel case with a latchable lid and handle. The tray is fitted with nylon coated aluminum holders, silicone instrument holders, and a protective mat. The instrument tray is marked to facilitate organized instrument placement. Recall # Z-2646-2011

MANUFACTURER:  Smith & Nephew, Inc. Endoscopy Division, Andover, MA, by letter dated May 19, 2011. Firm initiated recall is ongoing.

REASON:  Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU).

PRODUCT

1) First Breath Adult Oxygen Mask with Tubing, 213cm (7ft) Reorder Number: 001421 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume. Recall # Z-2647-2011;2) First Breath 3 in 1 Oxygen Mask with Reservoir Bag (1L) and Tubing, 213cm (7ft) (Non-latex) 50/CA Re-Order Number: 001423 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume. Recall # Z-2648-2011;3) First Breath Adult Aerosol Mask (Non-latex) 50/CA Reorder Number: 001426 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume. Recall # Z-2649-2011;4) First Breath ADULT Elongated Non-Rebreather Oxygen Mask with 1L Reservoir Bag & Tubing, 213cm (7ft.) 50/CA Reorder Number: 001431 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume. Recall # Z-2650-2011;5) First Breath PEDIATRIC Medium Concentration Oxygen Mask with Tubing, 213cm (7ft) (Non-latex) 50/CA Reorder Number: 001471 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume. Recall # Z-2651-2011;6) First Breath Pediatric Aerosol Mask (Non-Latex) 50/CA Reorder Number: 001476 for acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume. Recall # Z-2652-2011;7) First Breath Adult Face Tent (Non-latex) 50/CA Reorder Number: 001490 Face Tent Is a special type of aerosol mask used when the delivery of oxygen is not the primary objective. Normally this type of mask is used to deliver an aerosol mist to cool and moisturize the nasal passages or sinuses after surgery. Recall # Z-2653-2011;8) First Breath Adult Face Tent with Tubing 188cm (5ft.) (Non-latex) Reorder Number: 001492 Face Tent Is a special type of aerosol mask used when the delivery of oxygen is not the primary objective. Normally this type of mask is used to deliver an aerosol mist to cool and moisturize the nasal passages or sinuses after surgery. Recall # Z-2654-2011;9) First Breath Adult Venturi Oxygen Mask with Corrugated Tubing, O2 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-latex) 50/CA Reorder Number: 002610 for acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume. Recall # Z-2655-2011;10) Value Pack General Anesthesia Kit, (containing Reorder Number: 001421 Oxygen Face Mask) Reorder Number: VP1302 For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume. Recall # Z-2656-2011

MANUFACTURER:  Recalling Firm: Smiths Medical, Hythe, Kent, UK, by letter on February 14, 2011 and March 17, 2011.  Manufacturer: Unomedical S.A. de C.V., Reynosa, Tams, Mexico. Firm initiated recall is ongoing.

REASON:  A sticky substance on the inside and/ or outside of the Mask.

PRODUCT:

SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a given cutoff concentrations (refer to PN: 42131-SC). The SCREENERS Dip Drug Test is used to obtain a visual, qualitative result and is intended for professional use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation meth Drugs covered by the Screeners Dip Drug Test (SCD-7MB300): BAR, BZO, COC, MET, OPI300, PCP, THC. Recall # Z-2670-2011

MANUFACTURER

Ameditech Inc., San Diego, CA, by letter dated April 18, 2011. Firm initiated recall is ongoing.

REASON

The recall was initiated because Ameditech's internal review of regulatory files found that the two affected lots were manufactured without proper regulatory clearance.

PRODUCT

RUSCH Urinary Drainage Bag, 2000 ml Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine. a) Catalogue number: 390060; b) Catalogue number: 452919. Recall # Z-2672-2011

MANUFACTURER:  Recalling Firm: Teleflex Medical, Durham, NC, by letter dated June 2, 2011.  Manufacturer: Imed Technology, Inc., Dallas, TX. Firm initiated recall is ongoing.

REASON:  Sterile integrity cannot be guaranteed.

PRODUCT:

Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000. The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood for pH, pC02, p02, Na+, K+, Ca++, glucose, lactate and hematocrit. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance. Recall # Z-2673-2011

MANUFACTURER:  Instrumentation Laboratory Co., Bedford, MA, by letter dated April 2011. Firm initiated recall is ongoing.

REASON:  Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test results to an incorrect patient ID.

PRODUCT:

Spectra Optia Apheresis System, REF: 61000. The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange. Recall # Z-2674-2011

MANUFACTURER:  Caridian BCT, Inc., Lakewood, CO, by letter dated December 2010. Firm initiated recall is ongoing.

REASON:  An additional air detection system is being added to all existing systems to detect air in the system's return line.

PRODUCT:

Remel Spectra MRSA, a) Ref R01821, 10 plates per package, and b) Ref R01822, 100 plates per package. The product is a selective and differential chromogenic medium recommended for use in the qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA in healthcare settings. It is also intended for use in the qualitative detection of MRSA from positive blood cultures demonstrating gram-positive cocci on Gram stain. Recall # Z-2677-2011

MANUFACTURER:  Remel Inc., Lenexa, KS, by letter dated May 10, 2011. Firm initiated recall is ongoing.

REASON:  The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA).

PRODUCT:

1) Beckman Coulter UniCel DxI 800 Access Immunoassay System with UniCel DXI system software version 4.3.  Part Numbers: A71456, 973100, A25288, A25285. Recall # Z-2685-2011;2) Beckman Coulter UniCel DxI 600 Access Immunoassay System, Part Numbers: A71460 and A30260 with UniCel DXI system. Recall # Z-2686-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on July 6, 2010.Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.

REASON:  Test results may have incorrect ranges. If a default sample type setting on the tests screen is changed while running UniCel DXI system software version 4.3, the new setting is not saved to the system database. The changed sample type setting will reset to the previously saved setting when power is interrupted to the system, or if an operator reboots the system. If the default sample type is set to urine while running software version 4.3, the system will reset to the previously saved sample type setting, serum, when the power is interrupted or the system is rebooted. For an LIS test request with no specified sample type, the system applies the previously saved default sample type setting to the test request even if the system was not rebooted. A test result could be reported with ranges or a unit of measure corresponding to the previously saved sample type setting. Ranges may include references ranges, critical ranges, and LIS ranges defined on the DXI.

PRODUCT:

The product is the "FASTx Sternal Intraosseous Device". The device is used to insert an infusion tube into the manubrium (upper portion of the sternum) of a patient. It is intended for intraosseous infusion as an alternative to intravenous access, to facilitate emergency resuscitation through the use of drugs and fluids. It is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation. Recall # Z-2687-2011

MANUFACTURER:  Pyng Medical Corp., Richmond British Columbia, Canada, by letter dated November 5, 2010. Firm initiated recall is ongoing.

REASON:  Device failed to operate; the insertion of the infusion tube of the FASTx Sternal Intraosseous Device was not achieved in live subjects.

PRODUCT

1) LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4. Recall # Z-2688-2011;2) LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Small loop, 8mm connector, 1 X REF: EL-160-8 and 10 X REF: EL-160-8. Recall # Z-2689-2011;3) LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 8mm connector, 1 X REF: EL-200-8 and 10 X REF: EL-200-8. Recall # Z-2690-2011

MANUFACTURER:  LINA Medical ApS, Glostrup, Denmark, by newsletter in December 2009 followed by a letter in January 2010. Firm initiated recall is ongoing.

REASON:  Potential for the LiNA Loop to break during operating procedure.

PRODUCT

Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less than 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract. This device is not intended for the repair of GI tract luminal perforations. Recall # Z-2691-2011

MANUFACTURER:  Cook Endoscopy, Winston Salem, NC, by notice dated June 7, 2011. Firm initiated recall is ongoing.

REASON:  The disposable clip may not deploy after being positioned inside the patient.

PRODUCT

EOS system is a digital radiography system used in general radiographic examinations. sterEOS workstation is a medical image review station for acceptance, transfer, display, storage, and digital processing of 2D X-ray images. Recall # Z-2692-2011

MANUFACTURER:  Eos Imaging, Paris, France, by letter dated April 13, 2011. Firm initiated recall is ongoing.

REASON:  Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in certain cases, be affected by a different enlargement factor during printing.

PRODUCT

15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit. Catalog # THD155428.  Recall # Z-2693-2011

MANUFACTURER:  Medical Components, Inc dba MedComp, Harleysville, PA, by letter dated May 19, 2011. Firm initiated recall is ongoing.

REASON:  Product was packaged with the incorrect valued peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer.

PRODUCT

Tobii C-Series Lithium batteries Type TB8A, TB8B, TB12A used with the Tobii C8 and Tobii C12 Speech Generating Communication Devices. Communication device for the impaired and functions as a speech generating device; text or symbols can be used to generate synthesized or digitized speech. Perfect for asking or answering questions, having a conversation. Recall # Z-2694-2011

MANUFACTURER:  Recalling Firm: Tobii Assistive Technology, Inc., Dedham MA, by letter dated May 25, 2011.Manufacturer: Tobii Technology AB, Stockholm, Sweden. Firm initiated recall is ongoing.

REASON:  Lithium Batteries may overheat and become combustible.

PRODUCT

1) LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211 Product Usage:: Intravascular catheter. Recall # Z-2699-2011;2) LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product Code 2296.214 Product Usage: Intravascular catheter. Recall # Z-2700-2011

MANUFACTURER:  Recalling Firm: Vygon Corp., Montgomeryville, PA, by letter dated April 26, 2011.  Manufacturer: Vygon US LLC d/b/a Vygon Neuro, Norristown, PA. Firm initiated recall is ongoing.

REASON:  Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.

PRODUCT:

MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Product Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. Recall # Z-2707-2011

MANUFACTURER:  Recalling Firm: Carefusion 303, Inc., San Diego, CA, by letters on May 3, 20011.Manufacturer: Sistemos Medicos Alaris, Tijuana, B.C., Mexico. Firm initiated recall is ongoing.

REASON:  Carefusion has initiated a product recall for the MaxPlus bifuse extension set (minibore) needleless connectors Model MP9232-C as a result of a potential for occlusion. The product may be occluded at the bifused component.

PRODUCT:

Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double Mobility Liner Inserter Model Number: 01.26.10.0018 The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient’s condition should be due to one or more of: " Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, Congenital hip dysplasia, Ankylosing spondylitis.” A vascular necrosis of the femoral head. “Acute traumatic fracture of the femoral head or neck.” Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present. “Dislocation risks. Recall # Z-2709-2011

MANUFACTURER:  Recalling Firm: Medacta USA Inc., Camarillo, CA, by letter dated May 23, 2011.Manufacturer: Medacta International SA, Castel San Pietro, Switzerland. Firm initiated recall is ongoing.

REASON:  Medacta International has recently realized that the base of the Liner Inserter Ref 01.26.10.0018 Lot 105549 of the Versafitcup Double Mobility system could become rusty after the washing procedures. This is due to an incorrect raw material used by one of our suppliers during the production phase of this lot. For this reason, Medacta International has made the decision to remove all the pieces of this lot to prevent any possible problem of rust.

PRODUCT

The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO. UROLOGIX, CTC Advance Short, (2.5-3.5 cm), a) Catalog #: PT1034, Sterile EO. CTC Advance Standard , (3.0-5.0 cm), b)Catalog #: PT1036, Sterile EO. CTC Advance Long, (4.5+ cm), c) PT1038, Sterile EO. Targis Standard, (3.0-5.0 cm), d) PT1013, Sterile EO. The Urologix Targis system is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethral lengths greater than 2.5 cm.  Recall # Z-2710-2011

MANUFACTURER

Urologix, Inc., Minneapolis, MN, letter dated April 28, 2011.  Firm initiated recall is ongoing.

REASON:  The devices are packaged into disposable Procedure Kits containing a microwave catheter, a Coolant Bag and a RTU Plus balloon. The reason for this Recall involves three lots of Coolant Bags that contain an increased risk of leakage of water at the Sensor Module. This leak is detectable by the Control Unit whereby an error is generated; treatment is interrupted; and the Coolant Bag is replaced on the Control Unit. Urologix has conducted a thorough investigation and has determined that the discrepancy poses an extremely unlikely risk of injury with no potential adverse health outcome.

PRODUCT

Kurz, Surgical Implant, Clip - Piston MVP Titanium, REF: 1006 711. Product is designed for ossicular replacement to functionally restore the middle ear in cases of pathologic changes of the conductive hearing mechanism. Recall # Z-2711-2011

MANUFACTURER:  Heinz Kurz GmbH Medizintechnik, Dillingen, Germany, by letter dated May 9, 2011. FDA initiated recall is complete.

REASON:  Outer package labels product .75 mm longer than actual size.

PRODUCT

Pall Total Nutrient Admixture Filter, 1.2 micron filter This filter is a 1.2 micron low protein binding membrane indicated for the removal of inadvertent particulate debris and microorganisms (Candida Albicans) from total nutrient admixtures and undiluted intravenous fat emulsions. Product is designed for use with intravenous infusion pumps only. Recall # Z-2715-2011

MANUFACTURER:  Pall Life Sciences Puerto Rico LLC, Fajardo, PR, by letter dated June 15, 2011. Firm initiated recall is ongoing.

REASON:  Incorrect filter media used (0.2 um filter used instead of the required 1.2 um) within the TNA1 filter used with total parenteral nutrition mixtures.

PRODUCT:

1) ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests. Recall # Z-2716-2011;2) iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests. Recall # Z-2717-2011

MANUFACTURER:  Ventana Medical Systems Inc., Oro Valley, AZ, by letters dated May 16, 2011. Firm initiated recall is ongoing.

REASON:  The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection Kit  and one lot of iView DAB Detection Kit.

PRODUCT:

1) Pathfinder NXT Closure top driver - long, REF 3566-1, Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal. Recall # Z-2722-2011;2) Pathfinder NXT Closure top driver - short, REF 3566-2, Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal. Recall # Z-2723-2011

MANUFACTURER:  Recalling Firm: Zimmer Inc., Warsaw, IN, by letters dated April 2011.Manufacturer: Zimmer Spine Austin, Inc., Austin, TX. Firm initiated recall is ongoing.

REASON:  Zimmer Spine, Inc. is initiating a voluntary recall regarding an increased risk of rounding or partial rounding of the hex tip on the 3566-1 (long) and 3566-2 (short) Closure Top Driver used for insertion, provisional tightening, and final locking of Closure Tops during the screw and rod construct assembly of the Pathfinder NXT Pedicle Screw System. When the hex tip of the Closure Top Driver is not fully engaged with the hex feature of the mated Closure Top and/or the Closure Top Driver is used off axis, the hex tip of the Closure Top Driver can become rounded or partially rounded. During the instrumented techniques of compression, distraction, and reduction (which combine the respective instrument with the use of the Closure Top Driver), the potential exists that the driver may become partially lifted from full engagement with the Closure Top. And in some instances, the retention mechanism may provide sufficient resistance to falsely indicate full engagement. A rounded or partially rounded hex tip on a Closure Top Driver may not provide the required locking torque to final lock the Closure Top to the Polyaxial Screw. While hex tip rounding on re-useable Closure Top Drivers is a known risk in pedicle screw procedures and occurs to some extent on all pedicle screw systems, the Closure Top Driver in the PathFinder NXT Pedicle Screw System has exhibited an increased rate of rounding. Malfunction of the driver tip could cause delays in surgery until an alternative driver became available, resulting in the patients extended exposure to general anesthesia. In the event that all Closure Top Drivers in an instrument set become rounded and no alternative means to tighten the Closure Tops is available, a surgeon may need to remove the system and replace it with another pedicle screw system.

PRODUCT

1) IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0 IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface. Recall # Z-2724-2011;2) IQecg IQdevices SDK, Part Numbers: 4-100-1403, Software Version 8.3.2 Product Usage: IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface. Recall # Z-2725-2011;3) IQecg IQmanager Diagnostic Workstation, Part Numbers: 4-100-1200, Software Version 8.0.1, 8.3, 8.3.1, 8.3.2 IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface. Recall # Z-2726-2011

MANUFACTURER:  Brentwood Medical Technology Corp., Gardena, CA, by letter on May 19, 2010. Firm initiated recall is ongoing.

REASON:  The recall was initiated because when a user of the IQmanager, IQdevices SDK, and IQiC (Centricity) software versions listed above accesses the QT dialogue box to either accept or edit the QT value, the QTc value is recalculated using a Hodges QTc equation, regardless of patient's age. The software does this without notifying the user of the change from use of the Bazett equation, which is utilized for patients under the age of 16 years, to the use of the Hodges equation. If the user of the software does not access the QT dialogue box to accept or edit, then the QTc value for patients under 16 years of age is calculated from Bazett equation as expected. Midmark Diagnostic Group began shipping the software listed above on March 1, 2009. A copy of the shipping documents for the above referenced software is attached to aid you in identifying the software. The shipping documentation includes the part number(s) and date the software was shipped.

PRODUCT:

1) Dyonics Power Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew Dyonics Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities. Recall # Z-2731-2011;2) Dyonics Power Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew Dyonics Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities. Recall # Z-2732-2011

MANUFACTURER:  Recalling Firm: Smith & Nephew, Inc. Endoscopy Div., Andover, MA, letter dated May 6, 2011Manufacturer: Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA. Firm initiated recall is ongoing.

REASON:  Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use.

PRODUCT

JASMINE Full Body (Patient) Lift, electrically-powered device with a 500 lb. weight capacity. The recalled product is an electrically-powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another. The model number is JASMINE. Recall # Z-2741-2011

MANUFACTURER:  Recalling Firm; Invacare Corp., Elyria, OH, by telephone on April 8, 2011 and April 11, 2011, and by letter dated: April 18, 2011.Manufacturer: Invacare Rehabilitation Equipment Co., Ltd., Suzhou, China. Firm initiated recall is ongoing.

REASON:  Component Defect. The rear mast connector on certain patient lifts distributed by the firm, may break. Failure of the rear mast connector, while in use would result in a patient being dropped, possibly resulting in serious injury or death to the patient or care provider.

PRODUCT

HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accessories. Product Usage: Indicated for use in the coagulation of bleeding and nod-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Model number: 90-9200. Recall # Z-2745-2011

MANUFACTURER:  Barrx Medical, Inc. Sunnyvale, CA, by letter dated May 25, 2011. Firm initiated recall is ongoing.

REASON: Complaints of malfunction of the HALO ULTRA Ablation Catheter related to the device pivot mechanism's inability to return the electrode cap to a flat neutral position.

PRODUCT

1) smith&nephew NO-STING SKIN-PREP No-Sting Protective Wipes Effective protection between tape and skin Reduces risk of tape stripping Improves tape, film and appliance adhesion No-sting, non-irritating Reduces friction: Packaged 50 wipes per box. Formulation No. F-63, Product code 59420600 ----- Device Kits containing NO-STING SKIN-PREP Pouch Package Label: 12 month shelf life REF 66800882***RENASYS-G/P Gauze Dressing Kit with Port Small Kit***Rx only CE***.Case Label: REF 66800882 QTY 15***. ----- Package Label: 12 month shelf life REF 66800883***RENASYS-G/P Gauze Dressing Kit with Port Medium Kit*** Rx only CE***. Case Label: REF 66800883 QTY 15***. ----- Product Label: 12 month shelf life REF 66800884***RENASYS-G/P Gauze Dressing Kit with Port Large Kit*** Rx only CE***. Shipping Label: REF 66800884 QTY 15***. ----- Product Label: 9 month shelf life REF 66800491***RENASYS-G Gauze Dressing Kit - Small 10 Fr Round Drain*** CE***Rx only***. Case Label: REF 66800491 QTY 15***. ----- Product Label: 9 month shelf life REF 66800492***RENASYS-G Gauze Dressing Kit - Small 10mm Flat Drain*** ***Rx only CE ***. Case Label: REF 66800492 QTY 15***. ----- Product Label: 9 month shelf life REF 66800493***RENASYS-G Gauze Dressing Kit - Medium 15 Fr Channel Drain*** ***Rx only CE ***. Shipping Label: REF 66800493 QTY 15***. ----- Product Label: 9 month shelf life REF 66800494***RENASYS-G Gauze Dressing Kit - Medium 10mm Flat Drain*** Shipping Label: 66800494 QTY 15***. ----- Product Label: 9 month shelf life REF 66800495***RENASYS-G Gauze Dressing Kit - Large 19 Fr Round Drain*** **Rx only***. Shipping Label: REF 66800495 QTY 15***. ----- Product Label: 9 months shelf life REF 66800496***RENASYS-G Gauze Dressing Kit - Large 10mm Flat Drain*** ***Rx only CE ***. Shipping Label: REF 66800496 QTY 15***. ------ Package Labeling: 9 months shelf life ***REF 66800212***HIGH OUTPUT / FISTULA KIT Irrigation/Aspiration Drain - 28 Fr WOODING-SCOTT Technique***Rx Only CE ***. Shipping Label: REF 66800212 QTY 10***. ------ Product Usage: No-Sting Skin-Prep is indicated as an effective barrier between skin and tape. Recall # Z-2748-2011;2) BRAND: SKIN-PREP - Pouch Labeling and Box / Carton Labeling ***smith&nephew ***#420400***SKIN-PREP Protective Wipes Effective protection between tape and skin Reduces risk of tape stripping Helps tape, film and appliance adhesion Reduces friction Pediatrician tested***1 wipe***For external use only. Do not use with electrocautery procedures. Sting will be experienced if contacts cut or open wound. INGREDIENTS: Isopropyl Alcohol, Butyl Ester of PVM/MA Copolymer, Acetyl Tributyl Citrate. ------------------- Brand: SKIN-PREP Protective Wipes Bulk Case:***smith&nephew***SKIN-PREP Wipes BULK*** REF 420471 QTY 1000 Wipes ***. ------------------- Brand: SKIN-PREP CE Protective Wipes - Pouch Label: ***smith&nephew*** #59420425***SKIN-PREP***Box Label: ***smith&nephew***#59420425 SKIN-PREP 50***Carton Label: smith&nephew Wipes For International Export ***Quantity 20 Cartons of 50 REF #59420425***. ------------------ Brand: PERI-PREP CE Protective Wipes - Pouch Label and Box Label: ***Peri-Prep Peristomal Protective Dressing Wipe Product Code 840001 FOR ***SALTS HEALTHCARE***WARNINGS: Use only as directed. For external use only. do not apply to open wounds or mucus membrane. Avoid contact with eyes. Vapor may be harmful - use with adequate ventilation. Do no use with electrocautery procedures. FLAMMABLE: Do not use near heat, sparks or open flame. Keep out of reach of children. Seek medical advice before use on neonates. FIRST AID TREATMENT: If swallowed, give victim milk or water and induce vomiting. Call physician or poison control center immediately. If inhaled, remove to fresh air. If not breathing give artificial respiration, call physician. In case of contact with eyes, flush with water for 15 minutes including under eyelids. INGREDIENTS; Isopropyl Alcohol, Butyl Ester of PVM/MA Copolymer, Acetyl Tributyl Citrate. Brand: PERI-PREP CE - Case Label: ***smith&nephew Wipes Re-order #84001 ***PERI-PREP CE FLAMMABLE*** Quantity 20 Cartons of 50 REF #5132***. --------------- The following brand name products are manufactured using the same formulation . 1) SKIN-PREP Protective Wipes 50/Box Formulation F-06, Product Code 420400. 2) SKIN-PREP Protective Wipes Bulk Case 1000/Case Formulation F-06, Product Code 420471. [1000 individual wipes in a poly bag placed into a shipping carton.] 3) SKIN-PREP CE Protective Wipes 50/Box Formulation F-06, Product Code 59420425. 4) PERI-PREP CE Protective Wipes 50/Box Formulation F-06, Product Code 5132. Product Usage: Alcohol based liquid film-forming skin preparations that, upon application to intact skin, form a protective film to help reduce friction during removal of tapes and films. Skin-Prep can also be used to prepare skin attachment sites for drainage tubes, external catheters, surround ostomy sites and adhesive dressings. Recall # Z-2749-2011;3) Brand: UNI-SOLVE Adhesive Remover Wipe Pouch, 50 Count Box Label ***smith&nephew***#402300*** UNI-SOLVE Adhesive Remover Wipe Effectively removes tapes and adhesives Reduces irritation and risk of skin stripping Easy to use, no mess Gentle***1 wipe*** For external use only. Avoid eyes - Use with adequate ventilation. Keep out of reach of children. INGREDIENTS: C10-11 Isoparaffin, Isopropyl Alcohol, Dipropylene Glycol Methyl Ether, Aloe Extract, Fragrance. Brand UNI-SOLVE Adhesive Remover Wipes - Carton Label: smith&nephew Adhesive Remover Wipes ***UNI-SOLVE***Quantity 20 Cartons of 50 Code #402300*** -------------------- Brand: REMOVE CE Adhesive Remover Wipe - Pouch Label and 50 Count Box Label: ***smith&Nephew***#59403125***REMOVE***US Patent no. 5336207***CE***. Formulation F-57 S&N Product Code 402300 UNI-SOLVE Adhesive Remover Wipes. Formulation F-57 S&N Product Code 59403125 REMOVE CE Adhesive Remover. Product Usage: Reduce adhesive trauma to the skin by thoroughly dissolving dressing tape and appliance adhesives. Recall # Z-2750-2011;4) Brand REMOVE Universal Adhesive Remover Wipe - Pouch Label and 50 count box Label: ***smith&nephew***#403100*** REMOVE Universal Adhesive Remover Wipes Gently removes tapes and adhesives Reduces risk of irritation and skin stripping Contains Aloe***1 wipe and 50 wipes*** For external use only. Avoid eyes - Use with adequate ventilation. Keep out of reach of children. INGREDIENTS: Dipropylene Glycol Methyl Ether, C10-11 Isoparaffin, Aloe Extract, Benzyl Alcohol, Fragrance. ------------------- Brand: Universal Adhesive Remover Wipes - Carton Label: ***smith& nephew Universal Adhesive Remover Wipes ***Quantity 20 Cartons of 50 Code #403100***. Product Usage: Adhesive removers gently clean all types of adhesive residue from the skin, including hydrocolloid-based, acrylic-based and rubber-based adhesives. Recall # Z-2751-2011

MANUFACTURER:  Recalling Firm: Smith & Nephew Inc., Saint Petersburg, FL, by letter dated April 8, 2011.Manufacturer: H&P Industries dba HH&P LLC, Hartland, WI. Firm initiated recall is ongoing.

REASON:  These products were manufactured by H&P Industries dba The Triad Group who has initiated a recall of products manufactured in their facility for potential microbial contamination.

PRODUCT: 

Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system. Recall # Z-2754-2011

MANUFACTURER:  Medtronic Vascular, Danvers, MA, by letter dated June 7, 2011. Firm initiated recall is ongoing.

REASON:  Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve.

PRODUCT

Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO. The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair. As configured, the Elevate Anterior device is used solely for prolapse repair. Recall # Z-2755-2011

MANUFACTURER:  American Medical Systems, Inc., Minnetonka, MN, by letter dated May 9, 2011. Firm initiated recall is ongoing.

REASON:  This is an important notification regarding the Elevate Anterior and Apical Prolapse Repair Systems, Part Number 720093-01, manufactured between August 3, 2010 and January 17, 2011. We have recently received complaints stating that the eyelets were missing from the center graft of some units within the scope of this issue. The complaint rate to-date for the affected product is 0.045%, however there have been no injuries reported to AMS. .

PRODUCT:

ARIA, versions 8.0 and 8.1. Product Usage: Aria Radiation Oncology product is a treatment and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies. Model Number HIT-INFSYS, Recall # Z-2763-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on May 17, 2011. Firm initiated recall is ongoing.

REASON:  An issue has been detected when using the RT Chart function in ARIA versions 8.0 and 8.1. When users select the "Convert to Setup Field" option, a Set-up field is created, that removes the DMLC plan components in order to create an open collimator field for setup purposes.

PRODUCT:

Clinac Linear Accelerator; Model numbers H14, H27 and H29. Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall # Z-2764-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on May 18, 2011. Firm initiated recall is ongoing.

REASON:  The Coolant System input water supply manifold may leak in some Clinac Linear Accelerators, posing a risk of electrical shock to any person working within the protective housing.

PRODUCT:

TrueBeam Linear Accelerators (aka Trilogy Mx). Product Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors , and conditions anywhere in the body where radiation treatment is indicated. Model numbers: H14, H19, H27, H29. Recall # Z-2766-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on May 19, 2011. Firm initiated recall is ongoing.

REASON:  Imaging arms of the TrueBeam Accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry.

PRODUCT: 

1) Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-1 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders. Recall # Z-2772-2011;2) Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-1 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders. Recall # Z-2773-20113) Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-4 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders. Recall # Z-2774-2011;4) Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-4 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders. Recall # Z-2775-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated March 31, 2011.Manufacturer: Diagnostic System Laboratories Inc., Webster, TX. Firm initiated recall is ongoing.

REASON:  The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calibration. Erroneously elevated results may lead to unnecessary ultrasound testing to confirm gestational age, patient psychological stress until diagnostic testing is completed, and/or medical decisions based on screening results without further diagnostic testing.

PRODUCT:

Eclipse Treatment Planning System; Release 6.5 through 10 (build 7.3.10 through 10.0.34) Varian Medical Systems, Inc. Used to plan radiotherapy treatments for patients with Malignant or benign diseases. Plans beam irradiation with photon, electron and proton beams, as well as for internal radiation treatments; Model number 48. Recall # Z-2780-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated May 13, 2011. Firm initiated recall is ongoing.

REASON:  In affected Eclipse versions, user editing of the MLC Leaf positions may not automatically invalidate calculated dose distributions.

PRODUCT:

DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, part # 9733933. DICOM Query/Retrieve software is installed on Medtronic StealthStation systems. Product Usage: DICOM Query/Retrieve software enables the user to query a hospital Picture Archiving and Communication System (PACS) for patient DICOM scans. The user can then transfer the identified scan to a Medtronic StealthStation system. Recall # Z-2781-2011

MANUFACTURER:  Medtronic Navigation, Inc., Louisville, CO, by letter dated June 2, 2011. Firm initiated recall is ongoing.

REASON:  Software allows incorrect patient or patient history to be displayed.

PRODUCT:

Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF 0700610, Sterile, Contents...1 Each - PTFE Introducer and Dilator, 6.5 FR. x 10 cm..., Assembled in Mexico. Product Usage: Designed for short or long term access to the central venous system. They are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. Recall # Z-2783-2011

MANUFACTURER:  Recalling Firm: Bard Access Systems, Salt Lake City, UT, by letter dated June 16, 2011.Manufacturer: Bard Reynosa S.A. De C.V. Reynosa, Tamaulipas, Mexico. Firm initiated recall is ongoing.

REASON:  The Kit label indicates dimension for a wrong enclosed introducer.

PRODUCT:

1) Abbott Vascular ACS .035 Torque Device Part Number: 1003279. For use in cardiac diagnostic or therapeutic procedures. Recall # Z-2791-2011;2) Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number: 1003330. For use in cardiac diagnostic or therapeutic procedures. Recall # Z-2792-2011;3) Guidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and 667552-100. For use in cardiac diagnostic and therapeutic procedures. Recall # Z-2793-2011

MANUFACTURER:  Abbott Vascular, Temecula, CA, by letter, dated January 7, 2011. Firm initiated recall is complete

REASON:  Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization.

PRODUCT:

Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web, 1,000 needles per case. Product Usage: Aspiration and injection of fluids for medical purposes. Catalog Number 431, Catalog Number 443, Catalog Number 100280. Recall # Z-2798-2011

MANUFACTURER:  Terumo Medical Corp., Elkton, MD, by letter dated June 8, 2010 and by telephone on June 7 thru 9, 2010. Firm initiated recall is complete.

REASON:  Hypodermic needle packaging defect could compromise sterility.

PRODUCT

REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H). Healing abutment*** STERILE. Rx Only. Biomet 3i healing abutments are temporary healing abutments for use in maintaining the soft tissue opening throughout the healing process of dental restoration. Recall # Z-2799-2011

MANUFACTURER:  Biomet 3i, LLC, Palm Beach Gardens, FL, by telephone and letter dated March 1, 2010. Firm initiated recall is ongoing.

REASON:  The Healing Abutment dimensions did not match outside label and laser etching on part. The product was actually 8mm but the package indicated 6mm.

PRODUCT

1) Syneture Sofsilk 0 18" BLACK GS-21 DT non-absorbable braided nylon sutures CS10M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery. Recall # Z-2810-2011;2) Syneture Sofsilk 3/0 18" BLACK CV-25 DT non-absorbable silk sutures GS33M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery. Recall # Z-2811-2011;3) Syneture Sofsilk 5/0 BLACK 5 X 18" CV-22 D*TACH non-absorbable silk sutures GS43M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery. Recall # Z-2812-2011;4) Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS44M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery. Recall # Z-2813-2011;5) Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS46M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery. Recall # Z-2814-2011;6) Syneture Sofsilk 2/0 BLACK 5x18" V-20 D-TACH non-absorbable silk sutures GS62M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery. Recall # Z-2815-2011;7) Syneture Sofsilk 3/0 18" BLACK V-20 DT non-absorbable braided nylon sutures GS63M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery. Recall # Z-2816-20118) Syneture Sofsilk 2/0 30" BLACK V-20 DT non-absorbable braided nylon sutures GS66M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery. Recall # Z-2817-2011;9) Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon sutures S194 Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery. Recall # Z-2818-2011;10) Syneture Sofsilk 0 BLACK 6X 18" PRE-CUT WAX/RACE non-absorbable braided nylon sutures S196 Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery. Recall # Z-2819-201111) Syneture Surgilon 5/0 Blk 5X18 T-37/CV-20 D-TACH non-absorbable braided nylon sutures Material 8886191022 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue. Recall # Z-2820-2011;12) Syneture Surgilon 0 Blk 3X18 CE-10/C-16 non-absorbable braided nylon sutures Material 8886193662 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue. Recall # Z-2821-2011;13) Syneture Surgilon 0 Blk 5X18 T-12/GS-21 D-TACH non-absorbable braided nylon sutures Material 8886196262 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue. Recall # Z-2822-2011;14) Syneture Surgilon 0 Black 5X18 T-3/GS-23 D-TACH non-absorbable braided nylon sutures Material 8886199362 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue. Recall # Z-2823-2011;15) Syneture Surgilon 4/0 BLK 5X18 CV-22 D*TACH JLDT non-absorbable braided nylon sutures Material 8886195332J Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue. Recall # Z-2824-2011;16) Syneture Ti-Cron 0 BLUE 6X18" PRE-CUT non-absorbable polyester sutures Material 8886300162 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures. Recall # Z-2825-2011;17) Syneture Ti-Cron 0 5X18" BLUE T-19/GS-22 D-TACH non-absorbable polyester sutures Material 8886325962 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures. Recall # Z-2826-2011;18) Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-TACH non-absorbable polyester sutures Material 8886326062 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures. Recall # Z-2827-2011;19) Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-TACH non-absorbable polyester sutures Material 8886337272 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures. Recall #Z-2828-2011;20) Syneture Ti-Cron 2 BLUE 5X18" HGS-22 non-absorbable polyester sutures Material 8886337282 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures. Recall # Z-2829-2011;21) Syneture Ti-Cron 0 5X18" BLUE T-40/HGS-22 D-TACH, non-absorbable polyester sutures Material 8886337962 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures. Recall # Z-2830-2011

MANUFACTURER:  Covidien LP, North Haven, CT, by letter dated June 3, 2011. Firm initiated recall is ongoing.

REASON:  Potential for the sterile barrier to be breached compromising the sterility of the product.

PRODUCT:

1) "REF: 922070 TMJ System Arthrosimplicity KIT***Sterile Product***STERILE EO". THIS KIT WAS DISCONTINUED. Kit Contained: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; 60ml syringe; Gauze sponges; Extension tubing; Chloraprep swabsticks; Utility Bowl. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a TMJ arthrocentesis procedure. Recall # Z-2849-2011;2) "REF: 24-3050 TMJ SYSTEM OnPoint Scope Procedure Kit***Sterile Product ***STERILE EO***Kit Contains Both Sterile and Non-Sterile Components”. Kit Contains: Drape with pouch; 22g1.5in needle; OR towel; Towel clips; Skin marker with rule; Band-aids; Syringe pump tubing set; Cotton ball; 60ml syringe; Facial ice pack; Extension tubing; Chloraprep Swabsticks. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope. Recall # Z-2850-2011;3) "REF: 922090 TMJ System InnerVue Scope Procedure Kit***Sterile Product***STERILE EO***Kit Contains Both Sterile and Non-Sterile Components" KIT WAS DISCONTINUED. Kit Contains: Drape with pouch; 22g1.5in needle; OR towel; Towel clips; Skin market with rule; Band-aids; Syringe pump tubing set; Cotton ball; 60ml syringe; Facial ice pack; Extension tubing; Choloraprep Swabsticks; Shelf drape. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope. Recall # Z-2851-2011;4) “REF: 24-4050 TMJ System ArthroSimplicity Kit***Sterile Product***STERILE EO***Kit Contains Both Sterile and Non-Sterile Components" Kit Contains: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; Gauze sponges; Extension tubing; Cholarprep swabsticks; Utility Bowl. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope. Recall # Z-2852-2011

MANUFACTURER:  Biomet Microfixation, Inc., Jacksonville, FL, by letter on October 7, 2010. Firm initiated recall is ongoing.

REASON:  Biomet Microfixation is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ System ArthroSimplicity Kit REF 922070 & 24-4050; TMJ System InnerVue Scope Procedure Kit REF 922090. The OnPoint Scope Kits and ArthroSimplicity Kits contain Chloraprep Swabsticks that do not contain any warnings regarding the use of the product on eyes, ears or mouth.

PRODUCT:

Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. Recall # Z-2853-2011

MANUFACTURER:  Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on July 1, 2011 and sent a follow up letter dated July 6, 2011, Manufacturer: Baxter Healthcare SA, Singapore, Singapore. Firm initiated recall is ongoing.

REASON:  While replacing a defective pump head mechanism and performing calibration, Baxter's Service center may have failed to apply GLYPTOL (a red insulating varnish) on a potentiometer that helps maintain pump accuracy for detecting an air bolus.

PRODUCT:  Arthrex Reciprocating Saw Attachment Type: V-600SR. The system Is a modular electric system, consisting of a hand piece drive, various accessories, and a charging station for machining bones. It can be used in the following areas of application: orthopedic and A&E Interventions, such as osteotomies, large and small bone operations, and joint replacement operations. The charging station is intended exclusively for charging V 600 Li-Ion and V 300 LiIon rechargeable batteries. Recall # Z-2879-2011

MANUFACTURER:  W & H DentalWerk Buermoos GMBH, Burmoos, Austria, by letter dated May 24, 2011. Firm initiated recall is ongoing.

REASON:  Reciprocating saw attachment V 600 Sr (REF: 17306210), screws can become loose or come off (the attachment) and fall into the surgical wound and may not be noticed due to its small size.

PRODUCT:

Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized. The Biliary Drainage Bag is used to aid with fluid drainage involving abscess, biliary and nephrostomy. Mechanical failure of this device would result in patient discomfort. This device is not life sustaining no life supporting. The medical device is not intended to be implanted. This medical device has surface contact with the patient. Improper use of this device could cause fluid back-up and result in invasive contact through the catheter. The drainage bag will be used in conjunction with a nephrostomy/biliary drainage catheter. Recall # Z-2405-2011

MANUFACTURER :  Remington Medical, Inc., Alpharetta, GA, by letter dated January 12, 2011. Firm initiated recall is ongoing.

REASON:  There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.

PRODUCT:

12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with Limb Leads: The main cable includes the proximal connector which attaches to the monitor and four incorporated limb lead wires that terminate with ECG electrode snaps. All signals travel through this cable for cardiac monitoring and for 12-lead ECGs. Precordial Lead Attachment: The precordial lead attachment includes the precordial connector which attaches to the main cable with six precordial leads (also terminated with ECG electrode snaps). This attachment is used when a 12-lead ECG is needed. The main cable includes a cover over the connector for the precordial lead attachment to protect it from contaminants if the precordial lead attachment is not connected. This 12-lead ECG Cable Assembly is designed for use in the Pre-hospital and hospital environment. The 12-lead ECG cables are currently available for the LIFEPAK 12 Defibrillator/Monitor and LIFEPAK 15 Monitor/Defibrillator. The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST elevation myocardial infarction (STEMI). Documentation of transient or intermittent arrhythmias and other electrophysiologic events that occur in the pre-hospital setting can assist in diagnosis and treatment decisions in the Emergency Department. 12-lead ECG Cable with Limb Lead Attachment Part Numbers: 3302822-000-AHA; 3302822-002-AHA; 3302822-001-IEC; 3302822-003-IEC. Precordial Lead Attachment Part Numbers: 3302823-000-AHA and 3302823-001-IEC for 12-Lead ECG Cable. Recall # Z-2625-2011

MANUFACTURER:  Physio Control, Inc., Redmond, WA, by letter dated May 2011. Firm initiated recall is ongoing.

REASON:  The 12-lead ECG cables have experienced premature failures which cause the shielding and conductors to break internally creating ECG noise or "lead off" indications.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  July 27, 2011.

CLASS II

PRODUCT:

Condyle Kit with Hexalobular, REF 114700 Discovery Elbow System, Humeral Condyle Set - Hexalobular, CO-CR-MO YI-GAL-4V Alloy, If Used For Revision Surgery, Instruments 414926 & 414923 May be Required Lot 183300, 1 Set, Expiry Date: 2021-03 Elbow joint replacement prosthesis intended for primary and revision joint arthroplasty for use in cemented applications. Recall # Z-2660-2011

MANUFACTURER:  Biomet, Inc., Warsaw, IN, by letter dated May 25, 2011. Firm initiated recall is ongoing.

REASON:  The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle.

PRODUCT:

Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. It gives the capability to notify users of actions that need to take place prior to treatment, to display reference images for set up purposes and to auto setup the machine to predefined settings. Recall # Z-2662-2011

MANUFACTURER:  Impac Medical Systems Inc., Sunnyvale, CA, by letter on March10, 2011. Firm initiated recall is ongoing.

REASON:  There's a problem in the database conversion program that is used when upgrading from the Multi-ACCS to MOSAIQ or from one version of MOSAIQ to another. If the gantry start angle is incorrect prior to pressing beam-on, the patient will be mistreated.

PRODUCT:

Sequoia final driver closure top retention, non-sterile, REF 3384-2. The device is used to apply final torque to closure tops of the implant. The Sequoia Final Driver is used in conjunction with a counter torque tube to apply final torque to closure tops that secure the rod component to the screw head component until the torque limiting handle pops once, indicating the implant has been locked. This process is repeated with all closure tops in a construct (assembly). The Sequoia Final Driver is also used to tighten the set screw feature and lateral locking cams on the SpeedLinkII transverse connectors when used and is used to remove previously inserted closure tops during construct removal. Recall # Z-2705-2011

MANUFACTURER:  Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated April 4, 2011.Manufacturer: Zimmer Spine Austin, Inc., Austin, TX. Firm initiated recall is ongoing.

REASON:  A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdriver is not fully engaged and/or the screwdriver is used off axis, the hex tip of the screwdriver can become rounded or partially rounded.

PRODUCT

SoftReports versions 1.1.6.x and 1.1.7.x SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data from other SCC products. SoftReports enables users to customize standard reports generated by SCC systems to meet their specific needs. This system performs the following functions: 1. The ability to customize report layouts using beginner, intermediate, or advanced options. 2. The ability to import and export reports. 3. The ability to provide custom desktops to launch SQL's within other SCC applications. 4. The ability to preview and modify layouts specific to users' needs. 5. The ability to modify elements of reports using the comprehensive control formatting toolbar. 6. The ability to incorporate charts and graphics into reports. 7. The ability to modify existing query templates. 8. The ability to create independent and embedded queries. 9. The ability to pars SQL statements and notify users of errors within the syntax. 10. The ability to easily update criteria parameters to indicate input needed for executing queries. 11. The ability to view and print any report that is created using the Designer. 12. The ability to schedule, execute, and track ad-hoc reports. This system does not perform the following functions: 1. SoftReports is not configured to write back to the database. 2. SoftReports does not support user-created Ad Hoc reports being used for diagnostic purposes. 3. SoftReports is not intended to alter the meaning of patient result reports (test reports). Recall # Z-2714-2011

MANUFACTURER:  SCC Soft Computer, Clearwater, FL, by letter dated June 9, 2010. Firm initiated recall is ongoing.

REASON:  Potential hazard - when using SoftReports Layout Designer, results displayed in the report may not match the patient information in the report header.

PRODUCT:

TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System, part number 07-008, catalog number REF 8002. Recall # Z-2742-2011

MANUFACTURER:  Haemoscope Division of Haemonetics Corp., Niles, IL, by letter dated March 2, 2011. Firm initiated recall is ongoing.

REASON:  Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude).

PRODUCT:

Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, Sterile. This device is intended for use in the storage and retrieval of guide wires up to 9.8 ft. in length and recommended for guide wires of .018 to .038 inches in diameter. Recall # Z-2746-2011

MANUFACTURER:  Stryker Instruments Division of Stryker Corp., Kalamazoo, MI, by letter dated May 27, 2011. Firm initiated recall is ongoing.

REASON:  The towel clamps packaged with the wire caddy have been found to have blood stains on them which could result in infection or blood borne pathogen transmission.

PRODUCT:

Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to connect the catheter to the PD transfer set; Covidien product code 8814-661001, Baxter product code 5K4560. Recall # Z-2747-2011

MANUFACTURER:  Recalling Firm: Baxter Healthcare Renal Division, Mc Gaw Park, IL, by letter dated May 19, 2011.Manufacturer: Covidien LP, Mansfield, MA. Firm initiated recall is ongoing.

REASON:  A change made in the Quinton BETA-CAP adapter used to connect the patient PD catheter to the Baxter transfer set has resulted in a reduction in thread engagement which may lead to an increased risk of separation and the potential to develop peritonitis.

PRODUCT:

The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system. It is part of the position sensor system used to calculate the position of the instrument. The Tool Connection Unit is a component of the PercuNav Image Guided Intervention System. It is used to connect tracked instruments to the PercuNav system unit. It has a System Part Number: 989605392501, 989605396032, 989605395201. Tool Connection Unit Part Number: 453561426002, 453561443201 The model number: Stand-alone PercuNav: TX2-120, PercuNav integrated on iV22: TXV2. PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-operative guidance for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device. The system can support a diagnostic mode in which fused images are used to help locate and evaluate targets visible on one modality on a second modality. The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to another. Recall # Z-2769-2011

MANUFACTURER:  Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, byletter dated May 27, 2011.Manufacturer: Traxtal Technologies Inc., Toronto Ontario, Canada. Firm initiated recall is ongoing.

REASON:  PercuNav Tool Connection Unit may contain an electronic component that does not meet specification, which could cause registration difficulties and/or inaccurate instrument tracking.

PRODUCT:

Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands, H14, H19, H27, H29, Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-2778-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated May 13, 2011. Firm initiated recall is ongoing.

REASON:  Some drive stand bolts may fail to meet mechanical specifications.

PRODUCT:

Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Recall # Z-2782-2011

MANUFACTURER:  Recalling Firm: Bard Access Systems, Salt Lake City, UT, by letter dated June 2011.Manufacturer: Dymax Corp., Warrendale, PA. Firm initiated recall is ongoing.

REASON:  Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.

PRODUCT:

Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. Used for urine collection. a) Catalog number: A1300VA, b) Catalog number: A1300. Recall # Z-2831-2011

MANUFACTURER:  Teleflex Medical, Durham, NC, by letter dated June 27, 2011. Firm initiated recall is ongoing.

REASON:  The Kit contains Skin-Prep protective wipes that were manufactured by the Triad Group and are being recalled by Smith & Nephew, due to possible bacterial contamination.

PRODUCT:

LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000. The product is labeled in part: "Marus Dental". Product Usage: The intended use of the dental light is used for illuminating the oral cavity during the performance of dental procedures. Recall # Z-2834-2011

MANUFACTURER:  Dental Equipment LLC, Newberg, OR, by letter on June 24, 2011. Firm initiated recall is ongoing.

REASON:  Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient.

PRODUCT:

OneTouch Delica Lancing Device; Testing of Blood Glucose Levels. Model Number 022-137-01. Recall # Z-2835-2011

MANUFACTURER:  Recalling Firm: Lifescan Inc., Milpitas, CA, by letter dated May 27, 2011.Manufacturer: Facet Technologies LLC, Kennesaw, GA. Firm initiated recall is ongoing.

REASON:  Individuals attempting to remove a lancet from the OneTouch Delica lancing device without following instructions for use may experience an accidental needle stick.

PRODUCT:

Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit. Product code: CLXUSA. Recall # Z-2839-2011

MANUFACTURER:  Therakos Inc., Raritan, NJ, by letter dated December 2, 2010. Firm initiated recall is ongoing.

REASON:  Cellex Procedural kits may have minor tears in their Tyvek covers.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  July 20, 2011.

CLASS II

PRODUCT:

Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following size containers 5 gram tube, 2 ounce and 4 ounce tubes, 4 ounce bottle, 3 and 5 gram packets Intended use: A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. Brand names: 1) Allegiance, Cat. LJT2. Net Wt. 2 oz, Cat. LJF3, Net Wt. 3g, Cat. LJT4, Net Wt. 4 oz., Cat. LJT5, Net Wt. 5 g; 2) Select medical products, Reorder #137, 3 g/packet, Reorder #136, 4 oz; 3) Novaplus, Cat. No. V10-8344, Net Wt. 3 grams, Cat. No. V10-8919, Net Wt. 4 oz, Cat. No. V10-8917, Net Wt. 2 oz; 4) Triad Group, Inc., Cat. No. 10-8917, Net Wt. 2 oz, Cat. No. 10-8946, Net Wt. 5 g, Triad Plus Cat. No. 11-8344, 3 g, Cat. No. 11-8472, 5 grams, Cat. No. 10-8919, Net Wt. 4 oz, Cat. No. 10-8500, Net Wt. 4 oz; 5) IMCO, Reorder No. 8919-IMC Net Wt. 4 oz; 6) McKesson Medi-Pak Performance, Reorder No. 66-8919, Net Wt. 4 oz; 7) Henry Schein, Net Wt. 4 fl. oz. Recall # Z-0934-2011

MANUFACTURER:  H & P Industries, Inc. dba Triad Group, Hartland, WI, letter dated December 22, 2010. FDA initiated recall is ongoing.

REASON:  Triad Group is recalling all lots of Sterile Lubricating Jelly manufactured by Triad Group. This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products.

PRODUCT:

Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Ureteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first used to establish entry to various portions of the urinary tract (urethra, bladder, ureter), then a guidewire is threaded through the introducer. Following placement of the guidewire, various urological devices can be introduced into the targeted portion of the urinary tract for various therapeutic and diagnostic procedures. Recall # Z-2383-2011

MANUFACTURER:  Recalling Firm: Gyrus Acmi, Inc., Southborough, MA, by letter dated April 15, 2011.Manufacturer: Gyrus Medical, Inc., Osseo, MN. Firm initiated recall is ongoing.

REASON:  As a result of a manufacturing error in the production this lot of guidewires, some units of product were loaded in the dispenser backwards. In such cases, the stiff end of the guidewire would be dispensed from the product first and, if undetected, could be inserted into the patient. Depending on the specific clinical circumstances of the patient, this could potentially cause perforation of the ureter and surrounding anatomy. Therefore Gyrus ACMI has chosen, out of an abundance of caution, to conduct a voluntary recall of this lot of product.

PRODUCT:

Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed. Models: Eleganza 3 (1GZ17045 with Scale) or (1GZ07045 without Scale), Accessory: Mobi-lift handle (P/N D310105B) (Located towards the foot side of bed on both sides). Recall # Z-2411-2011

MANUFACTURER:  Recalling Firm: Linet Americas Inc., Charlotte, NC, by telephone on May 5, 2011 and letter dated May 11, 2011.
Manufacturer:Linet Spol Sr.O, Slany, Czech Republic. Firm initiated recall is ongoing.

REASON:  Linet has been made aware that there has been breakage of the Mobi-lift handle on a few beds which may cause failure during patient assist use.

PRODUCT: 

XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2579-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by notice dated September 14, 2010. Firm initiated recall is ongoing.

REASON:  XiO: When the beam template is recalled, XiO prematurely initiates a dose calculation, re-snaps the MLC or Port to the structure of the current patient , but then fails to re-calculate dose for the new MLC or Port position. If no subsequent change is made to force a dose recalculation, XiO will display the dose from the original MLC/Port shape dose instead of the dose from the re-snapped MLC/Port shape.

PRODUCT:

DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS DE INFUSION I.V.***REF 259-0250***50 Units***STERILE OE***Latex-Free. To control intravascular infusion of medication. Recall # Z-2601-2011

MANUFACTURER:  Leventon S. A. U., Barcelona, Spain, by letter dated March 11, 2011. Firm initiated recall is ongoing.

REASON:  Product has potential to leak.

PRODUCT:

BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing. Recall # Z-2608-2011

MANUFACTURER:  Recalling Firm: Becton Dickinson & Co., D Diagnostic Systems, Sparks, MD, by letter dated April 2011.

Manufacturer: Becton-Dickinson Diagnostics, Inc., Madison, WI. Firm initiated recall is ongoing.

REASON:  Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens.

PRODUCT:

Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. The owner's manual is labeled in part: "Pro Trainers' Choice' Company, Inc.***. The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***". Recall # Z-2659-2011

MANUFACTURER:  Pro Trainers' Choice Co., Kingston, WA, by letters on April 18, 2011 and April 20, 2011. Firm initiated recall is ongoing.

REASON:  The control panel of the Precision Ice One Patient Use Control Unit and Wrap System has a overheating issue. The control panel printed circuit boards were missing a jumper connection across resistors R28 A, B, C, and D.

PRODUCT:

1) ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7R20P14CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only. Recall # Z-2664-2011;2) HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number D7T20282CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only. Recall # Z-2665-2011;3) LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081- S, Catalog Numbers D7L2020CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only. Recall # Z-2666-2011;4) LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-1220-82-S, Catalog Numbers 07L2015CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only. Recall # Z-2667-2011

MANUFACTURER:  Biosense Webster, Inc., Irwindale, CA, by letter, dated May 24, 2011. Firm initiated recall is ongoing.

REASON:  20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.

PRODUCT:

1) RUSCH CrystalClear Tracheostomy Tube, Cuffed, Sterile Pack Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway. Catalog number: 121610 and 858510. Recall # Z-2695-2011;2) RUSCH Crystal Clear PDT, Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway. Catalog number: 121502. Recall # Z-2696-2011;3) RUSCH Percutwist Set with Crystal Clear Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patient's trachea surgically via the neck to maintain an open airway. Catalog number: 121556. Recall # Z-2697-2011

MANUFACTURER:  Recalling Firm: Teleflex Medical, Durham, NC, by notice dated January 4, 2011Manufacturer: Teleflex Medical Sdn Bhd, Kamunting Perak, Malaysia. Firm initiated recall is ongoing.

REASON:  Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.

PRODUCT:

NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test. Recall # Z-2740-2011

MANUFACTURER:  Recalling Firm : bioMerieux, Inc., Durham, NC, by letter on/about May 10, 2011.Manufacturer: Biomerieux Vitek Inc., Lyon, France. Firm initiated recall is ongoing.

REASON:  The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples.

PRODUCT: 

Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Sterile, Single Use, Rx ONLY For Functional Endoscopic Sinus Surgery for the incision of soft and osseous tissue in the sinus cavities, open plastic, and reconstructive surgery of the head and neck; Part number 5290-744-100. Recall # Z-2794-2011

MANUFACTURER:  Recalling Firm: Stryker Instruments Division of Stryker Corp., Kalamazoo, MI, by letter on June 13, 2011.Manufacturer: Stryker, Arroyo, PR. Firm initiated recall is ongoing.

REASON:  Recalled device was packaged with the incorrect angled blade. The labeling indicates a 12 degree angle but the product has a 40 degree angle.

PRODUCT:

XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex during perfusion of donor lungs. Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018. Recall # Z-2795-2011

MANUFACTURER:  Recalling Firm: Vitrolife, Inc., Englewood, CO, by letter on May 13, 2011.Manufacturer: Vitrolife Sweden Ab, Goteborg, Sweden. Firm initiated recall is ongoing.

REASON:  Precipitation observed in some bottles of electrolyte used for perfusion of donor lungs.

PRODUCT:

Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Product Codes: a) 2 M8153 and b) 2M8163. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Recall # Z-2796-2011

MANUFACTURER:  Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone beginning May 4, 2011.Manufacturer: Baxter Healthcare SA, Singapore, Singapore. Firm initiated recall is ongoing.

REASON:  The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.

PRODUCT

Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per case; product code 2N3375 Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device. Recall # Z-2837-2011

MANUFACTURER:  Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated July 6, 2011.Manufacturer: Baxter Healthcare of Puerto Rico S.A., Aibonito, PR, Firm initiated recall is ongoing. 

REASON:  Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  July 13, 2011.

CLASS II

PRODUCT:

DrugCheck, Model numbers: a) 70801-4 (NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-BUP-pH,SG-NI,CR, Export Only); b) 65500-4A (AMP-COC--OP1-TCH-MET-ALC-pH,SG-NI,CR, For forensic use only); c) 30705 ( DIP DRUG TEST, AMP500/COC/MDMA/MET500/MTD/OP1300/TCH); d) 60702-6A AUS (AMP300-COC300-OP1300-OP12000-MET300-TCH50-BZ0200-ALC-pH,SG,OX-NI,CR-GL, Export Only); e) 60600-A (AMP-COC--OP1-TCH-MET-BZO-ALC, For forensic use only); f) 61205 (AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC); g) 70701-4 (NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-pH, SG-NI,CR, Export Only); h) 31012-6 (DIP DRUG TEST, AMP/BAR/BZO/COC/MDMA/MTD/OPI/OXY/ PCP/THC/pH SG, OX/NI, CR, GL); i) 31003 (AMP/COC/OP10300/THC/MET/BZO/BAR/PCP/MTD/TCA/MET); Intended use: The DrugCheck Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine. Recall # Z-2387-2011

MANUFACTURER:  Express Diagnostics Int'l., Inc., Blue Earth, MN, by letter dated April 19, 2011. Firm initiated recall is ongoing.

REASON:  This recall was due to incorrect product expiration dating after findings from an FDA inspection. Use of expired product may not work properly, and may give incorrect screening results.

PRODUCT:

1) URI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732000 Intended use: Collector urine from male patients (and accessories) for indwelling catheter. Recall # Z-2392-2011; 

2) URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732500 Intended use: Collector urine from male patients (and accessories) for indwelling catheter. Recall # Z-2393-2011; 

3) URI-DRAIN Male Urinary Control Device - Large Product ID: 8884732598 (sold in Canada only) Intended use: Collector urine from male patients (and accessories) for indwelling catheter. Recall # Z-2394-2011

MANUFACTURER:  Recalling Firm: Covidien LP, Mansfield, MA, by letter dated April 29, 2011.Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is ongoing.

REASON:  A component of the Uri-Drain device recalled the Skin-Prep, a protective wipe due to bacterial contamination.

PRODUCT:

Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2561-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter on January 13, 2011. Firm initiated recall is ongoing.

REASON:  Monaco: For VMAT plans, the measured dose of radiation delivered is lower than the software calculated dose by about 5% in Monaco Release 2.03.00 and 2.04.00.

PRODUCT:

Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation. emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. including Neurosurgery. Gastrointestinal and affiliated organ surgery. Urological surgery. Plastic and Reconstructive surgery. General surgery, Orthopedic surgery. Gynecological surgery, Thoracic surgery. laparoscopic surgery and Thoracoscopic surgery. Recall # Z-2585-2011

MANUFACTURER:  Recalling Firm: Integra Limited, Plainsboro, NJ, by letter dated May 2, 2011.Manufacturer: Integra Lifesciences (Ireland) Limited, Sragh, Tullamore, CO, Ireland;Integra Radionics Inc., Burlington, MA. Firm initiated recall is ongoing.

REASON:  The insulated covering of a wire cable that powers the vacuum pump in the CUSA NXT Service Module can become abraded over time resulting in the exposure of bare wire. If this bare wire were to come in contact with the metal surface of the pump, it could result in a short circuit and a loss of aspiration.

PRODUCT:

Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, Provides direct tracheal access for airway management, a) Catalog # 180-060, and b) Catalog # 180-080. Recall # Z-2657-2011

MANUFACTURER:  Arcadia Medical Corp., Crown Point, IN, by email on May 8, 2011 and by letter on May 9, 2011. Firm initiated recall is ongoing.

REASON:  The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. This eliminates the user's ability to suction secretions through this suction port, necessitating that the user revert to standard of care methods for suctioning secretions from around the cuffed trach tube shaft.

PRODUCT:

Triad Alcohol Prep Pads, 0200086, 100 box 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test System; 0100007, Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombinme/lNR Testing Kit, Self- Test System; 0100072, Alcohol Prep Pads, packaged in the INRatio Starter Kit. Recall # Z-2661-2011

MANUFACTURER:  Alere San Diego, San Diego, CA, by letter on February 28, 2011. Firm initiated recall is ongoing.

REASON:  The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria Bacillus cereus, which could lead to life-threatening infections.

PRODUCT:

Infusable and InfusaScan Single Patient Use Pressure Infusors. A pressure infusor for an IV bag is a device consisting of an inflatable cuff which is placed around and IV bag. When the device is inflated, it increases the pressure on the IV bag to assist the infusion of the fluid. IN800012; IN80048; IN80020; IN900012; IN900048; IN900020; IN950006; IN950012. Recall # Z-2663-2011

MANUFACTURER:  Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated February 25, 2011.Manufacturer: Vital Signs Inc., Totowa, NJ. Firm initiated recall is ongoing.

REASON:  Infusable and InfusaScan Pressure Infusors may leak and not apply desired pressure to their IV solution bag and subsequently the rate of infusion may be inadequate.

PRODUCT:

1) AMS Acticon Neosphincter Pump, Product Number 72402287, Sterilization Method Steam. The Acticon Neosphincter is an implantable device used to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for less invasive forms of restorative therapy. Recall # Z-2668-2011; 

2) AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, InhibiZone Antibiotic Surface Treatment, AMS 800 Urinary Control Pump with InhibiZone, REF 72404127, Sterilization Method ETO. The AMS Urinary Control System (of which the pump is a component) is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. Recall # Z-2669-2011

MANUFACTURER:  American Medical Systems, Inc., Minnetonka, MN, by letter dated May 9, 2011. Firm initiated recall is ongoing.

REASON:  American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activation of the control pump which could lead to a health consequence.

PRODUCT:

1) Jet-Ventilator Catheter for Adults, 14G, Sterile, No Latex, REF 30-02-914-1. Allows a safe and atraumatic transtracheal access for oxygenation/ventilation with a manual jet ventilator or an automatic high frequency jet ventilator. Article number ACU 1060.2. Recall # Z-2675-2011;2) Jet-Ventilator Catheter for Adults, 14G, Sterile, No Latex, REF 30-02-918-1. Allows a safe and atraumatic transtracheal access for oxygenation/ventilation with a manual jet ventilator or an automatic high frequency jet ventilator. Recall # Z-2676-2011

MANUFACTURER:  Recalling Firm: VBM Medical Inc., Noblesville, IN, by letter dated May 9, 2011.Manufacturer: VBM Medizintechnik GmbH, Sulz Am Neckar, Germany. Firm initiated recall is ongoing.

REASON:  Product labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants.

PRODUCT:

Oxford Femoral Knee System REF 154600, WARNING DO NOT RESTERILIZE, Sterile Unless Pack Damaged, (510K# K011138). This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis. Recall # Z-2698-2011

MANUFACTURER:  Biomet U.K., Ltd. Bridgend, South Wales, United Kingdom, by letter dated April 21, 2011. Firm initiated recall is ongoing.

REASON:  This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device.

PRODUCT:

Codman Enterprise Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812. Recall # Z-2701-2011

MANUFACTURER:  Codman & Shurtleff, Inc., Raynham, MA, by letters on March 21, 2011. Firm initiated recall is ongoing.

REASON:  Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length.

PRODUCT:

Eclipse Radiation Treatment Planning System, model H48. Recall # Z-2702-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on May 3, 2011. Firm initiated recall is ongoing.

REASON:  In affected Analytical Anisotropy Algorithm versions when modeling the second source, the collimator jaw positions are read from the first control point of the field. This can cause the delivered dose to be higher than planned locally by up to 10%.

PRODUCT:

Broselow/Hinkle Pediatric Emergency System. The kit contains oxygen masks and blood pressure cuffs use on pediatric patients. Expiration for kit is four years. Oz Masks #D075986 Class I Exempt Device If you have purchased directly from Vital Signs, the product codes affected are: 7700BAW2, 7700GAW2, 7700OAW2, 7700PAW2, 7700RAW2, 7700WAW2, 7700YAW2, Kits with masks included: 7730ALS, 7730BLU5, 7730FLY, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5. If you have purchased directly from Armstrong Medical, the Product Codes affected are: a) AE-4700, , AE-4712, AE-4701, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, 7730GRN, 7700RAW, 7700PAW, 7700YAW, 7700WAW, 7700BAW, 7700OAW, 7700GAW. Medical Device Listing Blood Pressure Cuffs If you have purchased directly from Vital Signs, the product codes affected are: BP4030BR, BP4530BR, 7730POCH, 7730IALS If you have purchased directly from Armstrong Medical, the product codes affected are: b) AE-4703, AE- 4700, AE-4706, AE-4707. Recall # Z-2704-2011

MANUFACTURER:  Vital Signs Devices, a GE Healthcare Co., Totowa, NJ, by letter dated April 26, 2011. Firm initiated recall is ongoing.

REASON:  Broselow Pediatric Emergency System Kit may contain oxygen masks that may contain a potentially sticky substance on the inside and/or outside of the mask.

PRODUCT:

Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens Common Names Collamer single piece IOL Collamer plate haptic IOL. The Device is intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy). Recall # Z-2706-2011

MANUFACTURER:  Staar Surgical Co., Monrovia, CA, by letter on May 20, 2011. Firm initiated recall is ongoing.

REASON:  The recall was initiated by Staar Surgical due to an error in the Directions for Use (DFU) for Staar Surgical's Collamer Ultraviolet Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens (Collamer IP IOL), also known as the nanoFLEX IOL. The Device Description erroneously indicates that the lens could be implanted in the ciliary sulcus.

PRODUCT:

Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use, nonpyrogenic fluid pathway for use with 6200 and 6300 series Flo-Gard Volumetric Infusion Pumps; product code 2C7554s The tubing set is intended for use with Flo-Gard Infusion Pumps to provide epidural delivery of anesthetic or analgesic drugs for periods up to 96 hours. Recall # Z-2708-2011

MANUFACTURER:  Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated May 31, 2011.Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing.

REASON:  Product is being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.

PRODUCT: 

1) Comprehensive Shoulder Instruments Primary Shoulder Stem Inserter, REF 407398.  Instrument used to introduce the stem into the canal. The instrument is used to insert the shoulder implant into the shoulder. Recall # Z-2712-2011;2) Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF 31-406901. Instrument used to introduce the stem into the canal. The instrument is used to insert the shoulder implant into the shoulder. Recall # Z-2713-2011

MANUFACTURER:  Recalling Firm: Biomet, Inc., Warsaw, IN, by letters dated April 7, 2011 and April 12, 2011.Manufacturer: B & M Instruments, Inc., Warsaw, IN. Firm initiated recall is ongoing.

REASON:  When the surgeon attempts to remove the inserter from the stem, the inserter may become stuck not allowing it to disengage from the stem. The stem may have to be removed from the patient in order to disengage the inserter from the stem. If the stem is removed from the patient, it could potentially cause a significant delay in the procedure or damage/fracture of the humerus which may require intervention.

PRODUCT:

1) ECMO Heater Model 333, Cardiopulmonary bypass temperature controller. Part Number: 86130. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers. Recall # Z-2720-2011; 

2) ECMO Heater Model: 333W, Cardiopulmonary bypass temperature controllers. Part Number: 86135 (115V), 86136 (230V) and 86138 (240V).This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers. Recall # Z-2721-2011

MANUFACTURER:  Cincinnati Sub-Zero Products Inc., Cincinnati, OH, letter on May 2, 2011. Firm initiated recall is ongoing.

REASON:  The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use.

PRODUCT:

SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia. Recall # Z-2733-2011

MANUFACTURER:  St Jude Medical CRMD, Sylmar, CA, by letter on March 25, 2011. Firm initiated recall is ongoing.

REASON:  The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. The user is presented with the option to upgrade new software into the SJM Confirm ICM after the device is interrogated by a Mertin programmer with 10.1.1.2 software.

PRODUCT:

Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial baseplate stem. P/N 801-01-013. Recall # Z-2734-2011

MANUFACTURER:  Encore Medical, LP., Austin, TX, by letter dated April 20, 2011. Firm initiated recall is ongoing.

REASON:  Strike plate may dislodge from the broach stem handle during impaction of the device.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 6, 2011.

CLASS I

PRODUCT:

1) MicroStream Filterline Infant/Neonatal products: Part # 006285 - FILTERLINE H SET INF/NEO 25 UN PHYSIO (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in incubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807. Recall # Z-2233-2011; 

2) MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO 25 UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in incubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807. Recall # Z-2234-2011; 

3) MicroStream Filterline Infant/Neonatal products: Part # 008598 - FILTERLINE H SET INF/NEO 25UN DRAEGER (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in incubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807. Recall # Z-2235-2011; 

4) Micro Stream Filterline Infant/Neonatal products: Part # 010807 - VlTALINE H SET INFANT/NEONATAL 25UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in incubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807. Recall # Z-2236-2011

MANUFACTURER:  Oridion Medical 1987 Ltd, Jerusalem, Israel, by telephone, email and letter dated March 25, 2011. Firm initiated recall is ongoing.

REASON:  Fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient.

PRODUCT:

ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, glucose monitoring test strips. Recall # Z-2570-2011

MANUFACTURER:  Roche Diagnostics Operations, Inc., Indianapolis, IN, by press release on May 18, 2011. Firm initiated recall is ongoing.

REASON:  Erroneous results: Internal investigations revealed that the test strips exhibited a performance issue that can cause test strip errors or a bias in test result that exceed the tolerance range according to EN ISO 15197.

PRODUCT:

1) Integra LifeSciences Corporation Disposable, Convenience Kit PICC INSERTION TRAY Reorder Number 3403203 Sterile/EO. Recall # Z-2575-2011; 

2) Integra LifeSciences Corporation Disposable, Convenience Kit PICC INSERTION TRAY Reorder Number 10-2334, Sterile/EO. Recall # Z-2576-2011

MANUFACTURER:  Recalling Firm: Integra LifeSciences Corp. Plainsboro, NJ, by letter on May 20, 2011.Manufacturer: Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT. Firm initiated recall is complete.

REASON:  Kits contain protective wipes that may be contaminated with Bacillus cereus.

CLASS II

PRODUCT:

2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion. Recall # Z-1678-2011

MANUFACTURER:  Animas Corp., West Chester, PA, by letter dated February 22, 2011. Firm initiated recall is ongoing.

REASON:  Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking.

PRODUCT:

Precision 500D X-ray systems with under-table collimator part number 5234960 is designed to perform radiographic and fluoroscopic x-ray examinations. Recall # Z-1971-2011

MANUFACTURER:  GE Healthcare, LLC, Waukesha, WI, by letter on June 10, 2010. Firm initiated recall is ongoing.

REASON:  Use of high force when moving the image carriage/IDD into forward/park position can cause changes to the mechanical alignment of the collimator blades and allow the blades to open wider than specified, consequently allowing radiation outside the permitted field without warning to the user. This issue manifests with symptoms wherein the user cannot fully close down the lateral blades.

PRODUCT:

Lockheed Martin Aculight Capella-r 1850 Laser. The Capella Laser is intended for use in user-defined scientific applications and non-human-use research on infrared nerve stimulation. Recall # Z-2069-2011

MANUFACTURER:  Lockheed-Martin Aculight, Bothell, WA, by letter on November 19, 2010. Firm initiated recall is ongoing.

REASON:  It has been determined that there are certain software driven operating sequences involving off-on cycling of the key-switch that do not result in a reset of the Stim Enable button, and emissions can resume after a standard 5 second countdown without pressing this button a second time.

PRODUCT

1) Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V Alloy, REF 141224, Sterile, I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement. Recall # Z-2104-2011; 

2) Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V Alloy, REF 141232, Sterile, I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement. Recall # Z-2140-2011

MANUFACTURER:  Biomet, Inc., Warsaw, IN, by electronic communication on March 3, 2011. Firm initiated recall is ongoing.

REASON:  The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".

PRODUCT:

APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. Recall # Z-2129-2011

MANUFACTURER:  Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letters dated March 15, 2011.Manufacturers: Baxter Healthcare Corp., Singapore, Singapore;Baxter Healthcare Corp., Mountain Home, AR.Firm initiated recall is ongoing.

REASON:  Clinicians are being reminded of the current warning in The HomeChoice APD Systems Patient At-Home Guide, 07-19-61-244 (October 2,2009), which states on page 3-13 "To reduce the risk of burns, electrocution, fire, or injury to persons: Close supervision is necessary when this product is used by, on, or near children or those unable to care for themselves." Tubing entanglement around the neck may result in loss of consciousness, anoxic brain injury or death if the patient is in an incapacitated state resulting from a fall, seizure, medication effects, or any underlying condition with cognitive impairment and muscle weakness or inability to speak.

PRODUCT:

Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496. Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01. The data sheet is labeled in part: "***91387-27 SL2700 Patient Monitor***91387-28 SL2800 Advanced Patient Monitor***91387-38 SL3800 Central Monitor***Spacelabs Healthcare ***Ultraview SL***The Ultraview SL 2700 and SL2800 bedside modules, use external flat panel displays, and include a DC power supply that provides power for the monitor and up to three Flexoria system interfaces. The monitors include interactive networking, graphic and tabular trends, remote view and alarm watch support. They accommodate two single-high parameter SL3800 central monitor includes interactive networking, graphic and tabular trends, remote view, alarm watch, and central alarm manager. The central monitor accommodates a dual-high recorder module, uses an external flat panel display, and includes a DC power supply. In addition to central monitoring, the SL3800 provides bedside monitoring operation through Biomed-level control***". Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexport interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine: a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow net worked based applications to open Windows and display information on other net worked monitors. Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. Recall # Z-2134-2011

MANUFACTURER:  Spacelabs Healthcare, LLC, Issaquah, WA, by letter dated April 1, 2011. Firm initiated recall is ongoing.

REASON:  The circuit that supplies backup power to the modules in the Medical Patient Monitor, Model 91387, is not working. If there is a power interruption, the three-minute backup may not be operational and customers may lose any changes they have made to the alarm settings.

PRODUCT:

Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1. STERILE. To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures. a) Part: 103532; and b) Part: 103533. Recall # Z-2135-2011

MANUFACTURER:  Biomet, Inc., Warsaw, IN, by letter dated March 23, 2011. Firm initiated recall is ongoing.

REASON:  One lot of 30 mm screws was switched with one lot of 25 mm screws.

PRODUCT:

HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/carton. Each kit contains 100 tab electrodes and 26 alcohol pads. The electrodes are used to measure bodyfat analysis. The alcohol pads (non-sterile) are used for cleaning the skin to help the electrodes adhere better. There are no instructions for use with the kit. Recall # Z-2136-2011

MANUFACTURER:  Recalling Firm: Vermed, Inc., Bellows Falls, VT, by letter, telephone and e-mail on February 8, 2011.Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is ongoing.

REASON:  Vermed kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential Bacillus cereus contamination.

PRODUCT:

NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for the radiographer throughout the imaging process. NX communicates seamlessly with the hospital's picture archiving and communication system (PACS), radiology information system (RIS) and hospital information system (HIS). It is DICOM compliant and meets IHE guidelines. Recall # Z-2137-2011

MANUFACTURER:  Recalling Firm: AGFA Corp., Greenville, SC, by letter on March 4, 2011.Manufacturer: Agfa Gevaert Healthcare Gmbh, Peissenberg, Germany. Firm initiated recall is ongoing.

REASON:  When a radiographer is working on two open studies on an NX workstation and, in specific situations, a problem of image/annotation mix-up can occur on the NX system.

PRODUCT:

OSSEOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** REF IOSS413***Rx Only***BIOMET 3i Dental Iberica S.L. Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. Recall # Z-2139-2011

MANUFACTURER:  Biomet 3i, LLC, Palm Beach Gardens, FL, by letter, e-mail or fax on March 14, 2011. Firm initiated recall is ongoing.

REASON:  Biomet 3i is recalling their product Osseotite Certain Implant Device IOSS413. The internal thread was not manufactured correctly.

PRODUCT

Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes. Catalog number K1270. Recall # Z-2154-2011

MANUFACTURER:  Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated June, 2010. Firm initiated recall is ongoing.

REASON:  Results may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL across the assay range.

PRODUCT:

1) Brightview XCT, 3/8" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat panel x-ray imaging components. Brightview ECT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. Model number: 4535-607-49161, catalog number 882482. Recall # Z-2155-2011;2) Brightview XCT, 3/4" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flaot panel x-ray imaging components. Brightview ECT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. Model number: 4535-604-62131: catalog number 882350. Recall # Z-2156-2011

MANUFACTURER:  Recalling Firm: Philips Medical Systems, San Jose, CA, by letter in April 2011. Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. Firm initiated recall is ongoing.

REASON:  The current Headholder to support Bright View XCT brain imaging allowed for imaging the brain but dosen’t allow for imaging of the associated shoulder/neck area of the body.

PRODUCT

UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial). Recall # Z-2157-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc. Brea, CA, by letter on February 11, 2011. Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

REASON:  The recall was initiated because: The handheld barcode scanner does not read barcode labels using NW 7 symbology. Impact: Specimens with NW7 labels cannot be read by the handheld scanner.

PRODUCT:

1) BD Visitec High Viscosity Injector 4mm .90 (20G) [Hammer] REF 585173 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place. Recall # Z-2159-2011;

2) BD Visitec High Viscosity Injector 6mm [Hammer] .90mm (20G) Catalog Number: 585184 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place. Recall # Z-2160-2011;3) BD Visitec High Viscosity Injector 4mm [Hammer] .90 (20G) Catalog Number: 585208 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place. Recall # Z-2161-2011;4) BD Visitec High Viscosity Injector 6mm .90mm (20G) [Hammer] Catalog Number: 585228 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place. Recall # Z-2162-2011;5) S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place. Recall # Z-2163-2011;6) S5-7606 Silicone Oil injection Cannula 6mm Long - 20G REF 585247 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place. Recall # Z-2164-2011

MANUFACTURER:  Becton Dickinson and Co., Waltham, MA, letter dated December 7, 2010. Firm initiated recall is ongoing.

REASON:  Restricted or no fluid flow for Visitec High Viscosity Injector.

PRODUCT:

Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus. Recall # Z-2165-2011

MANUFACTURER:  Instrumentation Laboratory Co., Bedford, MA, by letter dated February 2011. Firm initiated recall is ongoing.

REASON:  Measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during patient blood analysis, leading to erroneously high results.

PRODUCT:

Statspin Express 4 Centrifuge Model Number: SSH4 Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes. Recall # Z-2169-2011

MANUFACTURER:  StatSpin, Inc., dba Iris Sample Processing, Westwood, MA, by letter in August 2010. Firm initiated recall is ongoing.

REASON:  Rotors may fail due to wire spokes breaking.

PRODUCT:

Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472 Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c), in human whole blood, on the Beckman Coulter AU680 with whole blood automated pretreatment (APT) capability only. For in vitro diagnostic use only. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio, and must not be used individually for diagnostic purposes. Recall # Z-2170-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on March 1, 2011. Manufacturer: Beckman Coulter Biomedical Ltd., Clare, Ireland. Firm initiated recall is ongoing.

REASON:  The recall was initiated because Beckman Coulter has identified a problem with two lots of HbA1c APT reagent OSR61177. When HbA1c APT reagent lots 9390 and 9472 are calibrated with HbA1c calibrator ODR3032, elevated recovery may be observed for patient samples. Falsely elevated HbA1c values may be interpreted as increased risk for diabetes or poorly controlled diabetes. Consequent medical actions include additional testing and administration of oral or increased doses of glucose lowering agents.

PRODUCT:

Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC. Kit contains components which are used to monitor Intra Cranial Pressure and provide access to the cerebral ventricles for Cerebro-spinal fluid sampling, drainage and fluid injection. Recall # Z-2171-2011

MANUFACTURER:  Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated February 22, 2011.Manufacturer: Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT. Firm initiated recall is complete.

REASON:  Outer box of Monitoring Kit was mislabeled with the incorrect part number.

PRODUCT:

UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial). Recall # Z-2172-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on February 11, 2011.Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

REASON:  The recall was initiated because: Specimen tubes may fall out of a Type A cassette (PN A53551, kit of 20) when the analyzer inverts the cassette in the mixing station, or when an operator manually inverts a cassette The impact: - Specimen tubes may fall out of cassettes and be misplaced inside the instrument - Specimen tubes may break upon impact, causing possible biohazard exposure - Patients may require a redraw for 'lost' or broken tubes.

PRODUCT: 

AutoMate TM Sample Processing System, P/N A20745 Basic Assembly - Automate The AutoMate system prepares sample tubes for diagnostic testing and for storage. The AutoMate system contains an automated track that connects to Input/Output, Centrifuge, Serum Level Detection, Decapper, and Output modules. The AutoMate TM 800 model also contains and Aliquot module. Recall # Recall # Z-2212-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated May 7, 2009.Manufacturers: Beckman Coulter Inc., Brea, CA; Ids Co., Ltd., Kumamoto, Japan. Firm initiated recall is ongoing.

REASON:  The recall was initiated because Beckman Coulter has confirmed an issue with the AutoMate Sample Processing Systems. If during the recovery from Error 81201001, a stuck sample carrier with a tube is moved backwards to the loading position, sample tube/input tray information will become mismatched for samples being loaded onto the AutoMate.

PRODUCT:

Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors. Software Releases A, B, C, D.0, D.01, E.0, E.01, F.0, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. Recall # Z-2217-2011

MANUFACTURER:  Philips Healthcare Inc., Andover, MA, by letter dated April 28, 2011. Firm initiated recall is ongoing.

REASON:  PAS-210 Kit Remote Active Speaker Assembly used with the IntelliVue Information CenterSpeaker cable connection may lead to intermittent or loss of audio alarm annunciation.

PRODUCT:

a) AVOXimeter 1000, b) AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use in the cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated. Recall # Z-2218-2011

MANUFACTURER:  International Technidyne Corp. Edison, NJ, by letter dated March 23, 2011. Firm initiated recall is ongoing.

REASON:  An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.

PRODUCT:

Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US market) The carbon-fibre MAGNUS table top serves to support and position patients for surgical procedures and interventional examination immediately before, during and after the surgical phase. The table top is radio translucent and enables intra-operative use of x-ray equipment. Recall # Z-2238-2011

MANUFACTURER:  Maquet Inc., Wayne, NJ, by letter dated April 15, 2011. Firm initiated recall is ongoing.

REASON:  Maquet GmbH's quality monitoring detected that incorrect cover sheets were installed with some Magnus carbon fiber table tops.

PRODUCT:

Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. The Bard Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropylene monofilaments. The device classification name is "Mesh, Surgical, Polymeric". Recall # Z-2239-2011

MANUFACTURER:  Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter dated April 25, 2011.  Manufacturer: Bard Shannon LTD, Humacao, PR. Firm initiated recall is ongoing.

REASON:  Mislabeling: complaints of product labeled as Bard Soft Mesh 4" x 6" containing Bard Soft Mesh 6" x 6".

PRODUCT

NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. Recall # Z-2241-2011

MANUFACTURER:  Philips And Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning, China, by letter dated February 9, 2011. Firm Initiated recall is ongoing.

REASON:  Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image.

PRODUCT:

Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help. Product code 1600-14-50. Recall # Z-2242-2011

MANUFACTURER:  Salter Laboratories, Division of Regulatory Affairs, Arvin, CA, by letter dated April 19, 2011. Firm initiated recall is ongoing.

REASON:  One complaint received of product in box different from what was on label.

PRODUCT:

ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system; Therapist Express Basic Part number 08515289; syngo RT Therapist Part Number 08162815; and syngo RT Therapist Connect/MOSAIQ OIS Part number 08168754. The ONCOR and PRIMUS may be updated to utilize the RTT v4.x software. Recall # Z-2243-2011

MANUFACTURER:  Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, letter on March 31, 2011.Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.

REASON:  Siemens found a potential safety issue related to patient treatment with table offsets on syngo RT Therapist (RTT) 4.1 and 4.2 which could result in dose being delivered to wrong location.

PRODUCT:

BacT/ALERT - FA Reagent Bottle The BacT/ALERT Microbial Detection System is used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having bacteremial/fungemia. The BacT/ALERT System and culture bottles provide both a microbial detection system and a culture media with suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and other normally sterile body fluid infections. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FA bottle. BacT/ALERT FA Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacterial and fungi) from blood and other normally sterile body fluids. Catalog number: 259791. Recall # Z-2244-2011

MANUFACTURER:  BioMerieux, Inc., Durham, NC, by Notice dated April 13, 2011. Firm initiated recall is ongoing.

REASON:  The charcoal suspension in a portion of the lot does not meet the intended density.

PRODUCT:

OSSEOTITE Tapered Certain Implant 4 x 11.5mm, REF INT411***Sterile Using Radiation***Rx Only. Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. Recall # Z-2245-2011

MANUFACTURER:  Biomet 3i, LLC, Palm Beach Gardens, FL, by letter dated March 14, 2011. Firm initiated recall is ongoing.

REASON:  The product is being recalled because the internal thread was not manufactured correctly.

PRODUCT:

IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range of users on any appropriate, networked workstation they have access to. Recall # Z-2246-2011

MANUFACTURER:  Recalling Firm: AGFA Corp. Greenville, SC, by letter on April 14, 2011.Manufacturer: Agfa Healthcare Corp., Carlstadt, NJ. Firm initiated recall is ongoing.

REASON:  Software issue that occurs after dictation of a study.

PRODUCT:

1) Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2541-2011; 2) Bio-modular reverse shoulder humeral tray with lock ring, 44 mm standard, sterile, single use, REF 11-113680. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2542-2011;3) Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, single use, REF 115348. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2543-2011;4) Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2544-2011; 5) Comprehensive reverse shoulder humeral tray with locking ring, 44 mm standard, sterile, single use, REF 115340. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2545-2011;6) Custom bi-angular to reverse shoulder humeral tray 44 mm sterile, REF CP561548. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2546-2011;7) Custom solar comprehensive reverse humeral tray with lock ring 44 mm +5mm, sterile, REF CP561659. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2547-2011;8) Custom biomodular humeral tray 44 mm sterile, REF CP561686. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2548-2011;9) Custom comprehensive reverse humeral tray set w/ lock rings 44 mm + 15 mm & + 18 mm sterile, REF CP561705. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2549-2011;10) Custom comprehensive reverse shoulder bio-modular base 44 mm humeral tray standard, REF CP561510. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2550-2011

MANUFACTURER:  Biomet, Inc. Warsaw, IN, by letter dated April 22, 2011. Firm initiated recall is ongoing.

REASON:  The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.

PRODUCT:

The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory, and metabolic status. Mainstream monitoring uses a self-calibrating CO2 sensor to ensure continuous monitoring without interruption of connection. Reusable, lightweight (<14 grams), or single-use airway adapters are available for both adult and neonatal (low dead space) patients. Respiration can be monitored via an airway adapter and endotracheal or tracheostomy tubes using the mainstream function of the module. The intended use statement that apply to the 91517 are continuous monitoring of carbon dioxide and oxygen. The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients. The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (i.e., clinic), or intra-hospital transport. This product is not designed for home use or for use in transport vehicles. Recall # Z-2573-2011

MANUFACTURER:  Spacelabs Healthcare, LLC, Issaquah, WA, by letter dated May 12, 2011. Firm initiated recall is ongoing.

REASON:  Capnography Module, Model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. This reset clears the RAM and the module returns to default settings.

PRODUCT:

B.Braun Celsa Medical, Celsite Venous Access Ports. Model ST301, ST305V, ST301G, ST501G and ST315 Reference # Model # 04430425 ST301 04430095 ST305V 04433823 ST301G 04437025 ST501G 04436725 ST315. Recall # Z-2671-2011

MANUFACTURER:  Recalling Firm: B. Braun Interventional Systems, Plymouth, MN, by letter on April 16, 2011.Manufacturer: B.Braun Celsa Medical, Chasseneuil, France. Firm initiated recall is ongoing.

REASON:  The affected products contain the incorrect winged Surecan needle accessory component in certain Celsite Access Port package configurations. The winged Surecan needle is used to deliver medications and fluids into implanted Celsite Access Ports. Two winged Surecan needle sizes are provided in Celsite U.S. package configurations: 20G (PN 4058631) or 22G (PN 16006593A). A 20G or 22G needle is provided dependent on the port size. The clamp of the incorrect needles identifies a maximum pressure of 325 psi; the current winged Surecan needles distributed in the U.S. Celsite package configurations do not identify a maximum pressure. Hazards associated with high pressure injection into these Celsite Access Ports could include: catheter migration and leak/product extravasations.

PRODUCT:

1) Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog AVHCT. Recall # Z-2678-2011;2) Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blood parameter module and hematocrit/saturation probe, catalog 500AHCT. Recall # Z-2679-2011;3) Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial and venous blood parameter modules, catalog 500AV. Recall # Z-2680-2011;4) Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blood parameter module, catalog 500A. Recall # Z-2681-2011;5) Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with venous blood parameter module, catalog 500V. Recall # Z-2682-2011;6) Terumo Cardiovascular Systems, CDI 101 Hematocrit/Oxygen saturation monitoring system, catalog 101. Recall # Z-2683-2011;7) Terumo Cardiovascular Systems, CDI 100 Hematocrit/Oxygen saturation monitoring system, catalog 100. Recall # Z-2684-2011

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated April 21, 2011. Firm initiated recall is ongoing.

REASON:  Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the CDI 500 system in a way that would cause inaccurate pH values. Because the pH value is used to calculate other values, these parameters could also be affected by the presence of Methylene Blue: K+, Base Excess, Bicarbonate, O2 Saturation, O2 Consumption. Methylene Blue and other vascular dyes could potentially interfere with readings on any CDI system, including the CDI 100 or 101 Hematocrit/Oxygen Saturation Monitor. It is possible that a user would make a decision to administer or withhold treatment during a cardiac surgical procedure based on the readings provided by a CDI system. If the readings were incorrect, then such an action might be incorrect and possibly harmful to a patient. Terumo CVS is updating the Operator's Manuals for all CDI systems with an updated WARNING and CAUTION statement.

CLASS III

PRODUCT:

Integra NeuroSciences, Combo Kit. A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement. Recall # Z-2194-2011

MANUFACTURER:  Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated February 22, 2011.Manufacturer: Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT, Firm initiated recall is ongoing.

REASON:  Outer packaging of Combo Kit was mislabeled with an incorrect lot number.

PRODUCT:

Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid Part number: 08-4000-LB. Formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates. Recall # Z-2551-2011

MANUFACTURER:  Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, by telephone and letter dated April 18, 2011.Manufacturer: Haemanuotec Inc., Quebec, Canada. Firm initiated recall is ongoing.

REASON:  Mislabeled: incorrect lot number printed on case labels.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  June 29, 2011.

CLASS II

PRODUCT:

1) Nexgen Complete Knee Solution Femoral and Provisional Impactor/Extractor, Nonsterile, REF 00-5901-026-00. Intended use: The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-2173-2011; 

2) Nexgen Complete Knee Solution Femoral Replacement Jaw for use with Femoral and Provisional Impactor/Extractor, Nonsterile, REF 00-5901-026-40. Intended use: The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-2174-2011

MANUFACTURER:  Zimmer Inc., Warsaw, IN, by letter dated March 14, 2011. Firm initiated recall is ongoing.

REASON:  The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of which were reported that the patient had to undergo additional x-rays to ensure the fractured clip had not been left in-vivo.

PRODUCT:

1) CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. Recall # Z-2185-2011; 

2) CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation probe, Catalog 500AHCT. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. Recall # Z-2186-2011; 

3) CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules, Catalog 500AV. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. Recall # Z-2187-2011; 

4) CDI Blood Parameter Monitoring System 500 with Arterial Blood parameter module Catalog number 500A. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. The CDI 500 system is a stand alone system that is used during extracorporeal procedures to continuously monitor the blood in the extracorporeal circuit, providing ongoing information about the blood parameters. Recall # Z-2188-2011; 

5) CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog number 500V. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. The CDI 500 system is a stand alone system that is used during extracorporeal procedures to continuously monitor the blood in the extracorporeal circuit, providing ongoing information about the blood parameters. Recall # Z-2189-2011

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated October 27, 2010. Firm initiated recall is ongoing.

REASON:  The CDI 500 monitor may display inaccurate values. These errors include inaccurate potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccurate values.

PRODUCT

Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guides, and freezer gel packs. Note: the kits do not contain the drug, Forteo. Intended use: Travel starter kits to hold the drug Forteo and supplies needed to deliver the subcutaneous injection. It is important to note that this recall does not affect or involve the Forteo Delivery Device. The starter kits did not contain the Forteo Delivery Device. Recall # Z-2191-2011

MANUFACTURER:  Eli Lilly and Company, Indianapolis, IN, by letters dated March 18, 2011 and March 28, 2011. Firm initiated recall is ongoing.

REASON:  Recalling the alcohol prep pads due to potential contamination with the bacteria, Ba-cillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

PRODUCT

Varian brand Clinac, Medical Linear Accelerator, All Varian Clinac with Model Numbers: H14, H18, H26, H27, H28, H29, Hcx; The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Recall # Z-2195-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated March 28, 2011. Firm initiated recall is ongoing.

REASON:  Varian has identified an anomaly whereby, following prolonged use, the screw fastener holding the wedge body to the tray may fail.

PRODUCT

Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO. The cannula perfuses blood to the ascending aorta during short-term (<6 hours) cardiopulmonary bypass procedures. The device is a Duraflo coated cannula intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Recall # Z-2196-2011

MANUFACTURER:  Edwards Lifesciences LLC, Draper, UT, by letter dated January 21, 2011. Firm initiated recall is complete.

REASON:  Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation.

PRODUCT:

Manta Ray" Anterior Cervical Plate (ACP) System, Intended use: The Manta Ray ACP System is an anterior cervical plate that is indicated for temporary stabilization of the cervical spine from C2-C7. Part Numbers: 22-10-0118, 22-10-0120, 22-10-0122, 22-10-0124, 22-10-0126, 22-10-0128, 22-10-0130, 22-10-0132, 22-10-0134, 22-10-0231, 22-10-0234, 22-10-0237, 22-10-0240, 22-10-0243, 22-10-0246, 22-10-0249, 22-10-0252, 22-10-348, 22-10-0351, 22-10-0354, 22-10-0357, 22-10-0360, 22-10-0363, 22-10-0366, 22-10-0369, 22-10-0372, 22-10-0375, 22-10-0468, 22-10-0472, 22-10-0476, 22-10-0480, 22-10-0484, 22-10-0488, 22-12-4014, 22-12-4015, 22-12-4016, 22-12-018, 22-13-4513, 22-13-4515, 22-13-4517, 22-14-4513, 22-14-4515, 22-14-4517, 22-15-4010, 22-15-4012, 22-15-4013, 22-15-4014, 22-15-4015, 22-15-4016, 22-5-4018, 22-16-4010, 22-16-4012, 22-16-4013, 22-16-4014, 22-16-4015, 22-16-4016, 22-16-4018, 22-17-4513, 22-17-4515, 22-17-4517, 22-18-4513, 22-18-4515, 22-18-4517, 22-20-0118, 22-20-0120, 22-20-0122, 22-20-0124, 22-20-0126, 22-20-0128, 22-20-0130, 22-20-0132, 22-20-0134, 22-20-0231, 22-20-0234, 22-20-0237, 22-20-0240, 22-20-0243, 22-20-0246, 22-20-0249, 22-20-0252, 22-20-0348, 22-20-0351, 22-20-0354, 22-20-0357, 22-20-0360, 22-20-0363, 22-20-0366, 22-20-0369, 22-20-0372, 22-20-0375, 22-20-0468, 22-20-0472, 22-20-0476, 22-20-0480, 22-20-0484, 22-20-0488, 22-20-0492, 22-21-4010, 22-21-4011, 22-21-4012, 22-21-4013 & 22-21-4014. Recall # Z-2197-2011

MANUFACTURER:  Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated January 10, 2011.Manufacturer: Theken Spine LLC, Akron, OH. Firm initiated recall is ongoing.

REASON:  The Package Insert (Information for Use) and information in the Surgical Technique should be revised to include additional warnings, precautions and possible adverse events.

PRODUCT

BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4. The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, for patients of all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. Recall # Z-2214-2011

MANUFACTURER:  Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letters dated January 19, 2011 and March 11, 2011.

Manufacturers: Ge Hangwei Medical Systems Co., Ltd., Beijing, China;

Yokogawa Medical Systems, Ltd., Hino-Shi, Tokyo, Japan.

Firm initiated recall is ongoing.

REASON:  GE Healthcare has become aware of a potential set of circumstances that could cause X-ray continuation during an unexpected table stop on certain BrightSpeed systems (BrightSpeed Excel/Edge/Elite Select and BrightSpeed Elite Computed Tomography X-ray Systems ) if this event were to occur on your system, patient safety may be impacted.

PRODUCT

Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies. Recall # Z-2215-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 18, 2010.

Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.

REASON: The recall was initiated because In addition to Access Tg Sample Diluent, an additional diluent, Access Wash Buffer II, was added to Thyroglobulin instructions for use (IFU) for evaluation of samples having Tg levels above the reportable range of the assay. When customers interchange between diluents there is an unacceptable shift in results. A median difference of 16% (ranging from 14% to 23%) between Wash Buffer II (revised diluent) and Thyroglobulin Sample Diluent(current diluent) was observed.

PRODUCT

ARTISTE, ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2. The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 software. The RT Oncologist v4.2 is currently only on Non-US systems. Intended use: Radiation therapy. Therapist Exoress Basis Part number 08515289 syngo Therapist Express Part Number 08162815 syngo RT Therapist Connect/ MOSAIQ OIS Part number 08168754. Recall # Z-2216-2011

MANUFACTURER:  Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 31, 2011.

Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.

REASON:  Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the ARTISTE Linac RT Therapist v4.2 in combination with RT Oncologist v.4.2 and use the remote "Online 2D Image Review.

PRODUCT

Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; Model Number: H48. The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. Recall # Z-2220-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated April 4, 2011. Firm initiated recall is ongoing.

REASON:  An anomaly in Eclipse Treatment Planning System, versions 8.0 to 8.6, whereby Actual SSD (source surface distance) value may not correspond to the Planned SSD value after Planning Approval.

PRODUCT: 

204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90. 204589 Robot Arm Label***PN 203999 SN ROB XXX 2011-01.***V 100/120/230 A 9.6/8.0/4.2 Hz 50/60***Weight 39.4kg***Class I Equipment Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1:2003 CAN/CSA-C22.2 No. 601-1-M90. 204588 Label With Guidance Module Number***PN 201251 SN GUD XXX 2011-01***Weight 51.7kg***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, En 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90***Manufactured in USA. THE RIO uses an infra-red camera for the purpose of spatial navigation. This camera is present on the Camera Stand and communicates with the Guidance Module to provide the locations of the tracked instruments (i.e. robotic-arm, patient trackers, probes, etc). The information is then used to provide the virtual representation of the patient anatomy and the tools on the monitor, and provides necessary information to the robotic-arm to ensure proper bone preparation.  Recall # Z-2232-2011

MANUFACTURER:  MAKO SURGICAL COR., Ft. Lauderdale, FL, by letter on November 22, 2010. Firm initiated recall is ongoing.

REASON:  This component can function improperly and cause the accuracy of the system to be outside of the specification listed by the manufacturer. An electrical component of the camera was purchased from a non approved vendor.

PRODUCT:

Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2564-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letter dated June 24, 2010. Firm initiated recall is ongoing.

REASON:  Monaco: due to a software defect, the Radiological Depth (cm) and SSD to DRP (cm) parameters are reported incorrectly on the Beam Summary Report. This occurs for all Monaco IMRT plans. One complaint was received.

CLASS III

PRODUCT:

Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Ref 8046M7. Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as masolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Recall # Z-2221-2011

MANUFACTURER:  Merz Aesthetics, Inc., Franksville, WI, via e-mail on April 6, 2011. Firm initiated recall is ongoing.

REASON:  The lot was supposed to be scrapped because it had failed to meet its Loss On Drying (LOD) specification. Unfortunately it had been marked as approved, released and shipped.

     CLASS I

PRODUCT:

1) Philips Microstream Model M1923A FILTERLINE H SET INF/NEO 25UN PHILIPS These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This is performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine. Manufactured from October 2010 through February 2011. The M1923A Filterline H Set is also shipped as part of the M3015A Measurement Server Extension, Product Option #K33. Recall # Z-2247-2011;

 2) Philips Microstream Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS. These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This is performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine. Manufactured from October 2010 through February 2011. Recall # Z-2248-2011

 MANUFACTURER:  Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated April 2011.Manufacturers: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Germany;Oridion Medical 1987 Ltd., Jerusalem, Israel. Firm initiated recall is ongoing.

REASON:  Fine plastic strands on inner surface of the infant/ neonatal airway adapter may become dislodged and inhaled by the patient.

CLASS II

PRODUCT:

1)  Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), and CELL-DYN 3700 SL (Sample Loader), Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories. 3700CS, list numbers: 02H30-01, 02H30-03; 3700SL, list numbers: 02H31-01, 02H31-03. Recall # Z-1701-2011;

2) Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample Loader). Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories. 3200CS list numbers: 04H59-01, 04H59-03; 3200SL, list numbers: 04H60-01, 04H60-03. Recall # Z-1702-2011

 3) Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample Loader). Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories. List numbers: 3500CS: 91340-01, 91340-03; 3500SL: 91350-01, 91350-03. Recall # Z-1703-2011;

 4) Abbott CELL-DYN 3000CS (Closed Sampler), CELL-DYN 3000SL (Sample Loader). Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories. List numbers: 91323-01, 91313-03 (3000CS) and List numbers 91325-01, 91325-03 (3000SL). Recall # Z-1902-2011

MANUFACTURER:  Abbott Laboratories, Santa Clara, CA, by letters, dated March 22, 2011. Firm initiated recall is complete.

REASON:  FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and smoking.

PRODUCT:

1) Toshiba Infinix-i, INFX-8000C. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1871-2011;

2) Toshiba Infinix-i, INFX-8000F. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1872-2011;

3) Toshiba Infinix-i, INFX-8000V. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1873-2011;

 4) Toshiba Infinix-i, DFP-8000D. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1874-2011

MANUFACTURER:  Toshiba American Medical Systems Inc., Tustin, CA, by letter beginning December 21, 2010. Firm initiated recall is ongoing.

REASON:  Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value.

PRODUCT:

i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia. Recall # Z-2022-2011

MANUFACTURER:  Abbott Point of Care, Nepean Ontario, Canada, by letter dated February 2011. Firm initiated recall is ongoing.

REASON:  i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit.

PRODUCT:

1) Hospira Latex-Free Blood Secondary Set, 26 Inch with Secure Lock; a sterile Rx tubing set for the administration of fluids from a blood bag in series with an I.V. solution bottle and I.V. set; List No. 4602-58 For the administration of fluids from a blood bag in series with an I.V. solution bottle and I.V. set. Recall # Z-2024-2011;

2) Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 100 Inch with Clave and Secure Lock; a sterile Rx tubing set for the alternate administration of fluids from a blood bag and I.V. solution container; List No. 12450-48 For the alternate administration of fluids from a blood bag and I.V. solution container. Recall # Z-2025-2011;

3) Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 99 Inch with Drip Chamber Pump, 210 Micron Filter, Prepierced Injection Site and Secure Lock; a sterile Rx tubing set for the alternate administration of fluids from a blood bag and I.V. solution container; List No. 12698-65 For the alternate administration of fluids from a blood bag and I.V. solution container. Recall # Z-2026-2011;

4) Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a sterile Rx tubing set for epidural administration of fluids with the Gemstar Pump; List No. 13744-28 For epidural administration of fluids with the Gemstar Pump. Recall # Z-2027-2011

MANUFACTURER:  Recalling Firm: Hospira, Inc., Lake Forest, IL, by letter dated March 28, 2011.

Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.

REASON:  There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.

PRODUCT:

1) Codman Disposable Twist Drill Product code: 80-1200. This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures. Recall # Z-2028-2011;

2) Ghajar Guide Ventriculostomy Kit Product Code: 80-1185 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures. Recall # Z-2029-2011;

3) Codman Metal Disposable ICP Kit Product Code: 80-1190. This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures. Recall # Z-2030-2011;

4) Codman Plastic Disposable ICP Kit, Adult Product Code: 80-1196. This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures. Recall # Z-2031-2011;

5) Codman Cranial Hand Drill Product Code: 82-6607. This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures. Recall # Z-2032-2011;

6) Codman Plastic Disposable ICP Kit, Complete, Adult Product Code 80-1197. This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures. Recall # Z-2033-2011

MANUFACTURER:  Codman & Shurtleff, Inc., Raynham, MA, by letters dated November 30, 2010 and January 31, 2011. Firm initiated recall is ongoing.

REASON:  Packaging defect may compromise sterility of device.

PRODUCT:

1) **REF MCA5-1SB*** 1 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA). ***ANSPACH***Sterile. Sterilized using Irradiation***Rx Only.***Made in the USA. Intended usage: Cutting and shaping bone including bones of the spine and cranium. Recall # Z-2034-2011;

2) ***REF MCA5-15SB ***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only*** Made in the USA. Intended usage: Cutting and shaping bone including bones of the spine and cranium. Recall # Z-2035-2011;

 3) ***REF MCA5-2SB*** 2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA). ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only*** Made in the USA. Intended usage: Cutting and shaping bone including bones of the spine and cranium. Recall # Z-2036-2011;

4) ***REF MCA7-15SB*** 1.5 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only*** Made in the USA. Intended usage: Cutting and shaping bone including bones of the spine and cranium. Recall # Z-2037-2011;

5) ***REF MCA7-1SB*** 1 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA). ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA. Intended usage: Cutting and shaping bone including bones of the spine and cranium. Recall # Z-2038-2011;

6) ***REF MCA7-2SB***2 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA). ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA. Intended usage: Cutting and shaping bone including bones of the spine and cranium. Recall # Z-2039-2011

MANUFACTURER:  Anspach Effort, Inc. Palm Beach Gardens, FL, by letter dated October 6, 2010. Firm initiated recall is ongoing.

REASON:  Anspach Effort, Inc. is recalling their Sterile Bone Cutting Burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. Anspach has not received any complaints related to this problem.

PRODUCT:

Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server software, Model 6465 for European Union LATITUDE 6.2 Patient Management System Website Server software, Model 6441 for Canada Server software, Model 6442 for Australia / New Zealand Intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. Recall # Z-2052-2011

MANUFACTURER:  Boston Scientific CRM Corp., Saint Paul, MN, by letter dated January 2011. Firm imitated recall is ongoing.

REASON:  Boston Scientific has determined that data within certain printed reports obtained from the LATITUDE Patient Management System may not be accurate, in that, the Most Recent Presenting Electrogram (MRP-EGM) for some of the selected patients may be either missing or incorrect.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  June 8, 2011.

CLASS I

PRODUCT:

1) VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic Use, 20 cards/box. The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall # Z-2049-2011;

 2) VITEK 2 Gram Negative Susceptibility Card, AST-N184, REF 411 154, For In Vitro Diagnostic Use, 20 cards/box. The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall # Z-2050-2011

MANUFACTURER:  Biomerieux Inc., Hazelwood, MO, by letter dated March 30, 2011 and April 4, 2011 and by press release on April 8, 2011. Firm initiated recall is ongoing.  

REASON:  The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

CLASS II

PRODUCT:

1) Rapid Response H.U.T. (Head Up Tilt) Table. Model 1017. Powered electrophysiology tilt table. Table can tilt -15 degrees to 90 degrees (Trendelenburg). Used in clinical and hospital settings by trained radiologists. Recall # Z-1973-2011

2) Rapid Response HUT (Head Up Tilt) Table. Model 1117. Powered electrophysiology tilt table with single drop section. Table that can tilt -15 degrees to 90 degrees (Trendelenburg). Used in clinical and hospital settings by trained radiologists. Recall # Z-1974-2011;

 3) Rapid Response HUT (Head Up Tilt) Table. Model 1217. Powered electrophysiology tilt table with dual 2 way drop section. Table that can tilt -15 degree to 90 degree (Trendelenburg). Used in clinical and hospital settings by trained radiologists. Recall # Z-1975-2011

MANUFACTURER:  Medical Positioning Inc., Kansas City, MO, by letter on February 1, 2010. Firm initiated recall is complete.

REASON:  The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures.

PRODUCT:

SoftPerm (synergicon A) Daily Wear Contact Lenses, Rx Only, Sterile. Contents: One sterile contact lens, rigid center/soft hydrophilic skirt (25% water), in normal saline solution buffered with sodium bicarbonate. SoftPerm contact lenses are indicted for daily wear (class II device) for correction of visual accuracy for keratoconus and in non-aphakic persons with non-diseased eyes that are myopic or hyperopic. Recall # Z-1976-2011

MANUFACTURER:  CIBA Vision Puerto Rico, Inc., Cidra, PR, by letters dated June 2010 and February 1, 2011. Firm initiated recall is ongoing,

REASON:  Out of specification values were obtained for sterility testing. The pH of the saline solution may be higher than the spec (up to pH 8.6 compared to a spec limit of pH 7.8). The osmolarity of the saline solution may be lower than specification (263 mOsm/kg compared to a spec limit of 270)

PRODUCT:

1) Sarns Flexible Weighted Sucker, Sterile, catalog 804113. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2001-2011;

 2) Sarns Flexible Weighted Sucker in K9 Pack (custom pack), catalog number 63635-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2002-2011;

 3) Sarns Flexible Weighted Sucker in WI CARDIOVASCULAR PUMP & TABLE PACK (custom pack), catalog number 64789-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2003-2011;

4) Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-02, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2004-2011;

5) Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-03, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall# Z-2005-2011;

6) Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-04, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2006-2011;

7) Sarns Flexible Weighted Sucker in PUMP & TABLE PACK with PALL (custom pack), catalog number 70579-04, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2007-2011;

8) Sarns Flexible Weighted Sucker in PUMP & TABLE PACK with PALL (custom pack), catalog number 70579-05, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2008-2011;

9) Sarns Flexible Weighted Sucker in X-COATED CUSTOM TUBING PACK, catalog number 70932-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2009-2011;

10) Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number 73013-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Flexible Intracardiac Sucker and Weighted Flexible Sucker are indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2010-2011;

11) Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number 73013-02, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Flexible Intracardiac Sucker and Weighted Flexible Sucker are indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2011-2011;

12) Sarns Flexible Weighted Sucker in X-COATED PUMP & TABLE PACK, catalog number 73067-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Flexible Intracardiac Sucker and Weighted Flexible Sucker are indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2012-2011

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter on

REASON:  The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. The firm has determined that the product’s instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However this is not stated in the IFU. The firm is conducting this recall to inform users of the hazards associated with using the weighted sucker to drain a cardiac chamber or placing it through a valve.

PRODUCT:

Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERILE EO;  (2) DeRoyal(R) Water Soluble Lubricant, 1 / Pack, Size: 2 oz Rx Only, REF 31-704, STERILE EO; (3) DeRoyal(R) Lubricant, Size: 5 Gram, Rx Only, REF 31-938, STERILE EO, Lubricating body orifices.  Recall # Z-2013-2011

MANUFACTURER:  Recalling Firm: DeRoyal Processing Center, New Tazewell, TN, by letter dated March 18, 2011.

Manufacturer: H & P Industries, Inc., Hartland, WI, Firm initiated recall is ongoing.

REASON:  Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies.

PRODUCT:

1) CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS Analyzer (refurb). Designed for in vitro diagnostic use in clinical laboratories. a) List Number 02H30-01; b) Refurbished list number: 02H030-03. Recall # Z-2014-2011;

2) CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL Analyzer (refurb). Designed for in vitro diagnostic use in clinical laboratories. a)List Number 02H31-01; b) Refurbished list number: 02H31-03. Recall # Z-2015-2011;

3) CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL Analyzer (refurb). Designed for in vitro diagnostic use in clinical laboratories. a) List Number 91350-01; b) Refurbished list number: 91350-03. Recall # Z-2016-2011;

4) CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS Analyzer (refurb). Designed for in vitro diagnostic use in clinical laboratories; a) List Number 04H59-01; b) Refurbished list number: 04H59-03. Recall # Z-2017-2011;

5) CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb). Designed for in vitro diagnostic use in clinical laboratories. a) List Number 04H60-01; b) Refurbished list number: 04H60-03. Recall # Z-2018-2011;

6) CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. List Number 08H67-01. Recall # Z-2019-2011;

7) CELL-DYN Sheer Valve Assembly Driver. a) List Number 8921204902, Pallet ID 48312339; Date Code 08-Feb-2011 Pallet ID 95795162. List Number 8921167602: Date Code 13-Dec-2010 Pallet ID 80671954; Date Code 15-Dec-2010 Pallet ID 32777397; Date Code 16-Dec-2010 Pallet ID 46425128; Date Code 18-Jan-2011 Pallet ID 42387574; and Date Code 20-Jan-2011 Pallet 81-GKZ. Recall # Z-2020-2011

MANUFACTURER:  Abbott Laboratories, Santa Clara, CA, byletters on March 15, 2011. Firm initiated recall is ongoing.

REASON:  The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.

PRODUCT:

Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation. Recall # Z-2067-2011

MANUFACTURER:  Therakos Inc., Raritan, NJ, by letter dated February 1, 2011. Firm initiated recall is ongoing.

REASON:  Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).

PRODUCT:

ACUSON S2000 ultrasound system. Intended for the following applications: Fetal, abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular Applications. Model Number 10041461-ACUSON S2000. Recall # Z-2051-2011

MANUFACTURER:  Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on March 15, 2011. Firm initiated recall is ongoing.

REASON:  The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report.

PRODUCT

S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. The User information is labeled in part: "***iE33 Ultrasound System ***User Information Update***4535 614 04811 Rev A***New S8-3t TEE Transducer*** This release of the iE33 Ultrasound System supports the S8-3t transesophageal echocardiographic (TEE) transducer. The S8-3t transducer is indicated for adult cardiac, pediatric cardiac and transesophageal uses, and operates in the following modes: B, M, Color M, CWD, PWD, high PRF, color Doppler, harmonic, XRES. The S8-3t Micro TEE is indicated for use on patients weighing at least 2.5 kg undergoing echocardiography exams in the ICU, echocardiography lab, interventional suite, or in the operating room during cardiac surgery. The S8-3t Micro TEE transducer can be identified by the designation "S8-3t" printed on the connector housing of the transducer. Recall # Z-2062-2011

MANUFACTURER:  Recalling Firm: Philips Medical Systems Nederlands, Best, Netherlands, by letter on March 28, 2011.

Manufacturer: Philips Medical Systems North America Co. Phillips, Bothell, WA. Firm initiated recall is ongoing.

REASON:  Users of the Philips model S8-3t Micro TEE Transducer have reported that significant image quality degradation may occur after a number of use/cleaning cycles. If users do not inspect the transducer for such damage prior to each use, imaging may not always be available, which could pose a risk for patients.

PRODUCT

Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and InterX Personal Sport packaged with Triad alcohol wipes. The alcohol wipes manufactured by the Triad Group were labeled under brand names Triad, Select, Select Medical Products, PSS Select or PSS World Medical Inc. Alcohol wipe is provided as a cleaning convenience for device electrodes. Recall # Z-2105-2011

MANUFACTURER:  Recalling Firm: Neuro Resource Group Inc., Plano, TX, by press release on February 7, 2011 and by e-mail on March 2, 2011.

Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is ongoing.

REASON:  Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.

PRODUCT:

AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Made in China; Article #9207010. Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps. Article #9207010 Transformer (The transformer can be found as an individual item shipped with the products listed below) a) 57018W Kit PNSA W/O Bat PK WIC b) 57027 Kit PNSA Shoulder Bag c) 57027-03 Kit PNSA Shoulder Bag CS/3 d) 57027POP Display PNSA e) 57027T Kit PNSA w/Battery Pack f) 57036 Kit PNSA Metro g) 57036-03 Kit PNSA Black Metro h) 57036T 57036-03 Metro Tagged i) 57038 Pump ADV POP Medical Ast. j) 57043 PNSA Without Kit k) 57045W Kit PNSA W/BAT PK WIC l) 57045WT KIT PNSA WIC W/BAT PK m) 57046 PNSA Tote without Kit n) 57062 Kit PNSA Backpack o) 57062-03 Kit PNSA Backpack CAl3 p) 57062T Kit PNSA Tagged Backpack q) 57063 PNSA Tote r) 57063-03 PNSA Tote 3-Pack s) 57063T PNSA Tote Tagged t) 6007113 Kit Motor Replacement Metro 2008. Recall # Z-2386-2011

MANUFACTURER:  Medela Inc., McHenry, IL, by letter dated April 4, 2011. FDA initiated recall is ongoing.

REASON:  The power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged if not properly handled

PRODUCT:

 Xpert Infinity Software, V 4.1a. System software for GeneXpert Infinity 48. Recall # Z-2401-2011

MANUFACTURER:  Cepheid, Sunnyvale, CA, by letter dated April 13, 2011. Firm initiated recall is ongoing.

REASON:  A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession.

PRODUCT:

XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2408-2011

MANUFACTURER:  Computerized Medical Systems Inc., Maryland Heights, MO, by letters beginning September 2010.  Firm initiated recall is ongoing.

REASON:  XiO Software is not transferring the correct information regarding coordinates for the radiation beam. The coordinates may not be accurate. If all the information is transferred at once, the information appears to be correct. If something is changed, edited, or the information is transmitted in parts, the coordinate information may not be accurate. Two patients were mistreated.

CLASS III

PRODUCT:

Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized. The Biliary Drainage Bag is used to aid with fluid drainage involving abscess, biliary and nephrostomy. Mechanical failure of this device would result in patient discomfort. This device is not life sustaining no life supporting. The medical device is not intended to be implanted. This medical device has surface contact with the patient. Improper use of this device could cause fluid back-up and result in invasive contact through the catheter. The drainage bag will be used in conjunction with a nephrostomy/biliary drainage catheter. Recall # Z-2405-2011

MANUFACTURER:  Remington Medical Inc., Alpharetta, GA, by letter dated January 12, 2011. Firm initiated recall is ongoing.

REASON:  There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  June 1, 2011.

CLASS I

PRODUCT:

Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version 2.004 or earlier. The product under correction is the DDU-100 AED. The AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is unconscious, unresponsive and not breathing. The indications for use also state that for patients under 8 years old, child/ infant electrode pads are to be used and that therapy should not be delayed to determine the patients exact age or weight. The AED must also be used by or on the order of a physician. These AEDs are sold under the brand names Lifeline AED and ReviveR AED. Recall # Z-2064-2011

MANUFACTURER:  Defibtech, LLC, Guilford, CT, by letter dated March 11, 2011. Firm initiated recall is ongoing.

REASON:  Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process.

CLASS II

PRODUCT:

Luxtec MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light Source This light source is designed to supply high-intensity light to a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure. Recall # Z-2060-2011

MANUFACTURER:  Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated March 8, 2011 and by telephone on March 9, 2011.
Manufacturers: Integra Radionics Inc., Burlington, MS;

Integra Luxtec, Inc., West Boylston, MA. Firm initiated recall is ongoing.

REASON:  Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.

PRODUCT:

LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Electronic patient records management system. Model Product Number LANTIS COMMANDER 4503178 LANTIS System 5835991 LANTIS Commander 6.1 5493072 LANTIS 6.1 Complete 8147527 LANTIS 6.1 Essential 8147535 LANTIS 8.3 Complete 8147543 LANTIS 8.3 Essential 8147550 LANTIS 8.3 Commander 8148178. Recall # Z-2151-2011

MANUFACTURER:  Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 23, 2011.

Manufacturer: Impac Medical Systems Inc., Sunnyvale, CA. Firm initiated recall is ongoing.

REASON:  There is a potential safety issue in regard to data transfer between LANTIS OIS system and the hospital Information System (HIS) when the HL7 (ADT) interfact is used.

PRODUCT:

The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber. Recall #Z-2199-2011

MANUFACTURER

Recalling Firm: Fresenius Kabi, LLC, Redmond, WA, by letter dated May 6, 2011.

Manufacturer: Fresenius Hemocare Netherlands B.V, Emmer-Compascuum, Netherlands. Firm initiated recall is ongoing.

REASON:  Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and recall expansion of Z-0616-2011.

PRODUCT:

Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports. Recall # Z-2201-2011

MANUFACTURER:  Recalling Firm: Bio-Rad Laboratories, Redmond, WA, by letter dated July 19, 2010, via FedEx.

Manufacturer: Bio Rad Laboratories, Marnes La Coquette, France. Firm initiated recall is ongoing.

REASON:  The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.

PRODUCT

1) Brilliance iCT, Computed Tomography X-Ray System, including the Brilliance iCT SP system, Model Numbers: 728311 and 728306. The affected systems are equipped with the following software version: 3.2.0.19010. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-2205-2011; 

2) Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity CT. The recalled units are equipped with software versions: 3.5.21028 and 3.5.25028. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-2206-2011; 

3) Brilliance Big Bore Computed Tomography X-Ray System, Model Number: 728243. The units subject to correction are equipped with software version: 3.5.17030. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-2207-2011

MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on March 8, 2011. Firm initiated recall is ongoing.

REASON:  A program software error in the algorithm produces image artifacts that could possibly lead to a misdiagnosis of patients who have small metal implants.

PRODUCT:

1) DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction. Recall # Z-2208-2011; 

2) DePuy Mitek GRYPHON T BR Anchor w/ORTHOCORD Product Code: 210812 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.Recall #Z-2209-2011; 

3) DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD Product Code: 210813 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction. Recall # Z-2210-2011; 

4) DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD Product Code: 210814 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction. Recall # Z-2211-2011

MANUFACTURER:  Recalling Firm: DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, by letter dated February 24, 2011.

Manufacturer: DePuy Mitek Sarl, Neuchatel, Switzerland. Firm initiated recall is ongoing.

REASON:  Metal debris in the shaft component of the device.

PRODUCT:

PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911. Designed to be used only with the PercuNav" image guided intervention system. The Field Generator Stand (with articulating Mounting Arm) is used to position the Field Generator near the area of interest. Recall # Z-2219-2011

MANUFACTURER:  Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on April 4, 2011. 

Manufacturer: Traxtal Technologies Inc., Toronto Ontario, Canada. Firm initiated recall is ongoing

REASON:  The PercuNav Field Generator Stand could tip over during set up, during use, or during transport.

PRODUCT:

Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Padgett Dermatomes - Model S, SB, and S6, Device Listing #E208841, 510 (k) exempt. The Integra Padgett Dermatomes are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. The Model S and S6 dermatomes are intended for professional use in hospitals, and similar medical facilities, where the patient will be under the supervision of trained personnel. The Model SB dermatomes are used in skin banks for the harvesting of cadaver tissues. Universal Power Supply, Part Number DP0007 and DP0800 , used in the Integra Padgett Dermatome, Model S, Part Numbers 3539-700; and the Integra Padgett Dermatome, Model SB, Part Number 3539-800; and the Integra Padgett Dermatome, Model S6, Part Number: 3539-900. Recall # Z-2225-2011

MANUFACTURER:  Recalling Firm: Integra LifeSciences Corp. Plainsboro, NJ, by telephone on March 10, 2011 and letters on March 11, 2011, March 14, 2011 and on April 12, 2011.

Manufacturer: Integra LifeSciences Corp., Cincinnati, OH. Firm initiated recall is ongoing.

REASON:  Dermatome power supply units distributed by the recalling firm may not meet the required medical device electrical safety regulations which can result in an increased potential for electric shock to the device user and/or patient.

PRODUCT:

Unicel DxH 800 Coulter Cellular Analysis System. A quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. Part # 629029. Recall # Z-2227-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on April 12, 2011.Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

REASON:  The recall was initiated because Beckman Coulter has confirmed the auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old.

PRODUCT:

Stryker, Impression, Non-Powered Mattress, Model 2980. The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for use on Stryker frames and on other frames supporting a 84" x 35" x 6" mattress. Recall # Z-2240-2011

MANUFACTURER:  Recalling Firm: Stryker Medical Division of Stryker Corp., Portage, MI, by letter dated April 29, 2011.  

Manufacturer: Flextronics Ems Ca, L'isletville, Canada. Firm initiated recall is ongoing.

REASON:

Affected mattresses may not conform to federal flammability standards.

PRODUCT:

syngo Dynamics version 9.0. The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images. Recall # Z-2293-2011

MANUFACTURER:  Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by letter dated March 24, 2011. Firm initiated recall is ongoing.

REASON:  If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a "Preliminary" watermark displayed.

PRODUCT

Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11. The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The E Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The E Series may be used for the monitoring a patients electrocardiogram (ECG). Recall # Z-2294-2011

MANUFACTURER:  ZOLL Medical Corp., Chelmsford, MA, by letter dated April 22, 2011. Firm initiated recall is ongoing.

REASON:  Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  May 25, 2011.

CLASS II

PRODUCT:

DigiView software release 3.4.4.4 through 3.5.5.2. Digiview is a digital image management and reporting system with an associated clinical database. It provides capture, review and storage of images together with report creation and data basing. Recall # Z-2166-2011

MANUFACTURER:  Digisonics, Inc., Houston, TX, by telephone and e-mail on October 17, 2008. Firm initiated recall is ongoing.

REASON:  Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed.

PRODUCT:

1) Philips NM3 Monitors, Model 7900 PHILIPS NM3 Monitor, English - P/N 1051674 PHILIPS NM3 Monitor, English Refurbished - P/N U1051674 PHILIPS NM3 Monitor, English, Demo Unit - P/N DU1051674 PHILIPS NM3 Monitor, Spanish - P/N 1060462 NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations. Recall # Z-2167-2011; 

2) Philips FloTrak Elite modules: FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations. Recall # Z-2168-2011

MANUFACTURER:  Respironics Novametrix, LLC., Wallingford, CT, by letter on January 4, 2011. Firm initiated recall is ongoing.

REASON:  Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than actual.

PRODUCT:

COULTER LYSE S III diff Lytic Part Number: 8546796. COULTER LYSE S III diff Lytic Reagent For use as an erythrocyte lytic agent for the quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER GEN S, MAXM, HmX, LH500, LH 750, and LH 780 hematology analyzers. Use with only ISOTON III or LH Series diluent. Refer to your instrument product manuals and/or online help, as applicable. Recall # Z-2213-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated December 28, 2010.

Manufacturer: Beckman Coulter Inc., Florence, KY. Firm initiated recall is ongoing.

REASON:  The recall was initiated by Beckman Coulter because the COULTER LYSE III diff Lytic Reagent Lot number 101554F was released for distribution to customers between November 17 and December 1, 2010 prior to completion of QC testing.

PRODUCT:

Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: a) 2M8151, b) 2M8161 and c) 2M9161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. Recall # Z-2222-2011

MANUFACTURER:  Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on April 14, 2011 and by letter dated April 27, 2011.

Manufacturer: Baxter Healthcare SA, Singapore, Singapore. FDA initiated recall is ongoing.

REASON:  The Hi-Pot safety testing may not have been conducted on the affected pumps during service, prior to being returned to the end user.

PRODUCT:

V-CATH Insertion Kits, Sterile; Product Code Number: 301-00. Recall # Z-2223-2011

MANUFACTURER:  Recalling Firm: Neo Medical, Inc., Fremont, CA, by fax on April 5, 2011, by telephone on April 7, 2011 and letters on April 11, 2011.

Manufacturer: Centurion Medical Products, Salisbury, NC. Firm initiated recall is ongoing

REASON:  Firm received recall notice from their contract manufacturer due to visible particulates in Bacteriostatic Sodium Chloride Injection, USP 0.9%, 30 mL vials that are included in insertion kits.

PRODUCT:

Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-2224-2011

MANUFACTURER:  Varian Medical Systems, Inc., Oncology Systems, Palo Alto, CA. by letter and on-site visit on March 31, 2011. Firm initiated recall is ongoing.

REASON:  The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing.

PRODUCT:

SYNCHRON Systems Calibrator 1, Part Numbers: 468405, The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON reagents, is intended for the calibration of immunoprotein tests on SYNCHRON LX and UniCel DxC Systems. Recall # Z-2226-2011

MANUFACTURER:  Beckman Coulter Inc., Brea, CA, by letter on the week of March 14, 2011. Firm initiated recall is ongoing.

REASON:  The recall was initiated because standardization of the Synchron Systems Calibrator 1, used for both the Synchron LX and UniCel DxC systems, has been established to the new IFCC Reference Preparation for Plasma Proteins, ERM-DA470k (formerly CR470) beginning with lot number M005558. During the standardization to the new IFCC standard, ERM-DA470k, we confirmed that Complement C4 (C4) had been recovering low compared to the old IFCC standard, CRM470. However, beginning with Synchron Systems Calibrator 1 lot M005558, the setpoint for C4 has been value-assigned to produce C4 assay recovery to match the ERM-DA470k target value. Internal studies show Quality Control and patient sample recovery for the other analytes defined in LX Calibrator 1 were not affected. The Synchron Systems Calibrator 1 lots listed above would have resulted in approximately 30% lower results. Revised Quality Control ranges and a patient correlation for C4 are attached for your convenience.

PRODUCT:

COULTER Ac"T" 5diff Fix Reagent. Part Number: 8547171 COULTER AC"T" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to differentiate subpopulations of cells on COULTER Ac"T 5diff hematology analyzers. Intended for use only with specific Ac"T 5diff reagents. Refer to the instrument product manuals and/or online help, as applicable. Recall # Z-2231-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on April 8, 2011.

Manufacturer: Horiba ABX SAS, Montpellier, France. Firm initiated recall is ongoing.

REASON:  The recall was initiated because Beckman Coulter has confirmed that an issue has been identified with one of the raw materials used to manufacture the Coulter A T 5 diff PN 8547171.

PRODUCT:

Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D) Adaptor. Single Patient Use. Do not Sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help. Product Code: 4707-7-7-25. Recall # Z-2237-2011

MANUFACTURER:  Salter Laboratories, Division of Regulatory Affairs, Arvin, CA, by letter dated April 19, 2011. Firm initiated recall is ongoing.

REASON:  Complaint received that the product in the box was different from labeled product.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  May 18 2011.

PRODUCT:   

Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. a) Catalog Numbers: 270-2415 and b) 270-2417; The Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II. TURBO Hemoglobin Alc Program is intended for Professional Use Only--For In Vitro Diagnostic Use. Reagent Kit Information: The VARIANT II TURBO Hemoglobin A1c program utilizes principles of ionexchange high performance liquid chromatography (HPLC). The VARIANT II Hemoglobin A1c Program is based on chromatographic separation of HbAlc on a cation exchange cartridge. System Overview: The VARIANT II TURBO Hemoglobin testing System provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin Alc in EDTA human whole blood. Technology Overview: The V ARIANT II TURBO Hemoglobin Testing is a fully automated, high-throughput hemoglobin analyzer. It consists of two modules- the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT II TURBO System using Clinical Data Management (CDM) software. CDM is a dedicated software package of instrument control, data control, results analysis, calibration, quality control and service software. Recall # Z-1932-2011

MANUFACTURER:  Bio-Rad Laboratories Inc., Hercules, CA, by letter dated December 1, 2009. Firm initiated recall is ongoing.

REASON:  Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping baseline can affect hemoglobin test results.

PRODUCT:   

1) UniCel DxI 800 Access Immunoassay Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanufactured A25288, DxI 800 with spot B A71456, DxI 800 Reconditioned A25285 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Recall # Z-1938-2011;

 2) UniCel DxI 600 Access Immunoassay Systems; Part Number(s): DxI 600: A30260, DxI 600 with spot B A71460 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Recall # Z-1939-2011;

3) UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems; Part Number(s): DxC 660i: A64871, DxC 680i: A64903, DxC860i: A64935, DxC 880i: A59102 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Recall # Z-1940-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, letter dated January 26, 2011.  

Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.

REASON:  The recall was initiated due to Beckman Coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. The first rack of the two was not scanned. This is referred to as a "pushed pair." If a pushed pair event occurs, results may be associated with the incorrect patient identification. The association of results with the incorrect patient identification may lead to misdiagnosis, inappropriate testing, inappropriate treatment, and/or delayed treatment.

PRODUCT:   

1) Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116. Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray. Recall # Z-1941-2011;

 2) Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE. Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating atomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray. Recall # Z-1942-2011

MANUFACTURER:  OEC Medical Systems, Inc., Salt Lake City, UT, by letter dated March 1, 2011. Firm initiated recall is ongoing.

REASON:  Sensor cables may suffer material degradation when exposed to certain sterilization procedures.

PRODUCT:   

Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation. Recall # Z-2067-2011

MANUFACTURER:  Therakos Inc., Raritan, NJ, by letter dated February 1, 2011. Firm initiated recall is ongoing.

REASON:  Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).

PRODUCT:

Biomet CC I-Beam Tibial Plate 75mm Interlok 67mm Fixed CR Tibia Plate 67mm REF 141224, Biomet, Interlok 75MM Fixed I-Beam Tibial Plate with Locking Bar, CO-CR-MO/TI 6AL 4V Alloy, qty 1, Sterile R, 2010-09, Expiry Date: 2020-09 I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.

Recall #Z-2104-2011

MANUFACTURER:  Biomet, Inc., Warsaw, IN, by electronic communication on March 3, 2011. Firm initiated recall is ongoing.

REASON:  The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".

PRODUCT:   

1) Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8111KCV (30 Test Kit), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices. Recall #  Z-2106-2011;

 2) Clearview iFOB, Clearview - Sample Kit (5 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8112KCV (5 Test Kit), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices. Recall # Z-2107-2011;

 3) Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (25 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8114KCV (25 Test Kit), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices. Recall # Z-2108-2011;

 4) Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8115KCV (25 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices. Recall # Z-2109-2011;

 5) Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory) Product Part Number: 8116KCV Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices. Recall # Z-2110-2011;

 6) Clearview iFOB, Clearview - Clearview iFOB Return Mailer (accessory) Product Part Number: 8117KCV Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices. Recall # Z-2111-2011

MANUFACTURER:  Recalling Firm: Alere North America, Orlando, FL, by letter dated March 21, 2011Manufacturer: Tianjin New Bay Bioresearch Co., Ltd., Tianjin, China. Firm initiated recall is ongoing.

REASON:  Potential for false negatives test results and negative/faint positive controls.

PRODUCT:

UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). Recall # Z-2114-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, letter on October 20, 2010.

Manufacturer: Beckman Coulter, Inc., Miami, FL.  Firm initiated recall is ongoing. 

REASON:  For Panels containing CBC: The RBC and HCT are improperly corrected and not flagged when there is a WBC Pump Failure and the WBC ~ 140x103/uL. For Body Fluid Panels: The RBC is improperly corrected and not flagged when there is a WBC Pump Failure. IMPACT: Erroneous RBC and/or HCT could affect the interpretation and management of patients at risk with various types of anemias.

PRODUCT:   

The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. Recall #Z-2119-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on February 28, 2011. Firm initiated recall is ongoing.

REASON:  A software anomaly, in that the Multileaf Collimator (MLC) message displayed on the 4DITC on versions 8.6 and below, does NOT interlock beam delivery.

PRODUCT

UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).  

Recall # Z-2121-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 20, 2010.Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

REASON:  RETIC results may be invalid when the instrument user interface allows reflex processing of a pre-diluted specimen in the RETIC test panel. Beckman Coulter has validated pre-diluted specimen processing in CBC panels. RETIC test panel using pre-diluted samples has not been validated. IMPACT: The reticulocyte value is an indicator for assessing red cell production. Erroneous results could impact clinical decision making involving reticulocyte percentages or absolute counts

PRODUCT:

Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link. Recall # Z-2175-2011

MANUFACTURER:  Philips Healthcare Inc., Andover, MA, by letter on March 16, 2011. Firm initiated recall is ongoing.

REASON:  Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended.

PRODUCT:

Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System. Recall # Z-2177-2011

MANUFACTURER:  Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated June 2010. Firm initiated recall is ongoing. 

REASON:  Patient results may be falsely depressed or falsely elevated across the assay range.

PRODUCT:

Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound System. Recall # Z-2179-2011

MANUFACTURER:  Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter on April 20, 2010.

Manufacturer: Toshiba Electron Tubes & Devices Co., Ltd., Otawa-Shi, Tochigi, Japan

REASON:  There is a possibility of the system shutting down owing to the power supply unit causing the protection function to activate thus turning off the system prematurely.

PRODUCT

Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19; Code numbers: H191011, H191019, H191027, H191033, H191012, H191021, H191028, H191037, H191013, H191023, H191030, H191043, H191016, H191025, H191031, H191045, H191018, H191026, H191032, H191047. Recall # Z-2181-2011

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on April 5, 2011. Firm initiated recall is ongoing.

REASON:  Position sensor failure mode may result in an inaccurate position calculation. The error manifests itself in one of two possible ways. 1. The video returned by one of the two cameras inside the Spectra is all white or all black. The consequence of this failure symptom is that the Spectra stops tracking immediately. 2. The video returned by one of the two cameras inside the Spectra is returned but certain video intensities are not available. This results in a video image where transitions from dark to light portions of the image are more abrupt than normal, without the shades of gray that would normally separate the dark and light regions of the image.

CLASS III

PRODUCT:

Quest MPS and MPS 2 Consoles, Quest Medical, Inc., an Atrion Company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery. Recall #Z-1924-2011

MANUFACTURER:  Quest Medical, Inc., Allen, TX, by letter in July 2010. Firm initiated recall is ongoing. 

REASON:  User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.

PRODUCT:   

Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, A1 c) in whole blood. The separation is based on the principles of high performance liquid chromatography. Technology Overview: The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-1 0 incorporates the use of a dedicated software system for instrument control, data collection and analysis. The D-10 Software performs reduction of raw data collected from each analysis. Reagent Kit Information: The D-10 Hemoglobin A1c Program utilizes principles of ion-exchange High-performance liquid chromatography (HPLC). The D-10 Hemoglobin Ale Program is based on chromatographic separation of HbA1c on a cation exchange cartridge. The Bio-Rad D-10 Hemoglobin Ale Program is intended for the percent determination of hemoglobin A1 c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad D-10 Hemoglobin A1c Program is intended for Professional Use Only. The D-10 Hemoglobin A1c Program is for use only with the Bio-Rad D-10 Hemoglobin Testing System. Recall # Z-1969-2011

MANUFACTURER:  Bio-Rad Laboratories Inc., Hercules, CA, by letter dated September 8, 2010. Firm initiated recall is ongoing.

REASON:  The firm discovered that the Update Kit Floppy Diskette included in the reorder pack was mislabeled with an incorrect Lot Number for the Calibrator/Diluent Set as: S01819; The correct Lot Number for the Calibrator/Diluent Set is: S01704.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  May 4, 2011.

CLASS II

 PRODUCT:

1. Ellex Super Q LQP3106 ophthalmic laser. Recall # Z-1840-2011;2) Ellex Ultra Q LQP3106-U ophthalmic laser. Recall # Z-1841-2011;
2. Alcon 3000LE ophthalmic laser. Recall # Z-1842-2011;
3. Ellex Tango LT5106-T ophthalmic laser (not sold in USA). Recall # Z-1843-2011;
4. Ellex Solo LT5106-S ophthalmic laser (not sold in USA). Recall # Z-1844-2011

MANUFACTURER:  Ellex Medical Pty Ltd, Adelaide, Australia, by Service Bulletin dated 25 February 2011. Firm initiated recall is ongoing.

REASON:  Unintended laser emission while the user was moving the joystick for targeting.

PRODUCT:

Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Recall # Z-1901-2011

MANUFACTURER:  Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO, by letter dated March 14, 2011.

Manufacturer: Gambro Lundia Ab - Disposables Division, Lund, Sweden. FDA initiated recall is ongoing.

REASON:  Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure.

PRODUCT:

STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressible, reusable, critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. Devices processed in a SYSTEM IE have been chemically sterilized using S40 Sterilant Concentrate, a peracetic acid liquid chemical sterilant and rinsed with extensively treated, potable water. Recall # Z-1960-2011

MANUFACTURER

Steris Corporation Hopkins Facility, Mentor, OH, by letter dated March 14, 2011. FDA initiated recall is ongoing.

REASON:  The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing System are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the warning messages used in the printout, display, and Operator Manual omits the qualifying term: *liquid chemically* (not **sterilized), when alerting the user to incomplete processing.

PRODUCT: 

1. ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Recall # Z-1962-2011; 
2. ExactaMix EVA Container, 250mL, REF: 737, Sterile R. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Recall # Z-1963-2011 
3. ExactaMix EVA Container, 500mL, REF: 738, Sterile R. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Recall # Z-1964-2011; 
4. ExactaMix EVA Container, 1000mL, REF: 739, Sterile R. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Recall # Z-1965-2011; 
5. ExactaMix EVA Container, 2000mL, REF: 740, Sterile R. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Recall # Z-1966-2011; 
6. ExactaMix EVA Container, 3000mL, REF: 741, Sterile R. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Recall # Z-1967-2011

MANUFACTURER: Baxa Corp., Englewood, CO, by letter dated March 8, 2011. Firm initiated recall is ongoing.

REASON:  TPN bags may leak during filling operation, due to bag manufacturing error.

PRODUCT:

UniCel DxC Clinical Systems with UniCel DxC 600 Part #: A10405, UniCel DxC 600 PRO Part #: A11810, UniCel DxC 600i Part #: A27318, UniCel DxC 660i Part #: A64871, UniCel DxC 680i Part #: A64903, UniCel DxC 800 Part #:A11816, UniCel DxC 800 PRO Part #: A11812, UniCel DxC 860i Part #: A64935, and UniCel DxC 880i Part #: A59102 Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP, CFR, CDQ, CEM, CGN, CGZ, CHL, DCK, DFT, JFP, JGS, JHI, JIY, JJE, JLW, JMG, JXM, LCD & LCP. Recall # Z-1972-2011

MANUFACTURER:  Beckman Coulter Inc., Brea, CA, by letter dated November 16, 2010. Firm initiated recall is ongoing.  

REASON:  The hose clamps in the DxC (with serial numbers less than 3412, labeled behind the lower right side instrument door) hydropneumatic system are sharp and pose a possible risk of injury. An operator could be cut by the hose clamps, which could in turn result in increased exposure to any waste products (biohazards) that might be present on the assembly.

PRODUCT:   

1. UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). Recall # Z-1977-2011; 
2. UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). Recall # Z-1978-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 20, 2010.Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

REASON:  There is a possibility that a specimen could be diluted if a user requests Diluent Dispense while specimens are being automatically processed in cassette presentation. The dilution may cause erroneous results. IMPACT: Erroneous results from a diluted specimen could impact clinical decision making in cases such as blood transfusion, chemotherapy or antibiotic administration- particularly for populations with small volume specimen draws such as newborns.

PRODUCT:   

Coulter AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356. The Coulter ACT-T 5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial). Recall # Z-1979-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated February 23, 2011Manufacturer: Horiba ABX SAS, Montpellier, France. Firm initiated recall is ongoing.

REASON:  The recall was initiated because Beckman Coulter identified a problem with occasional unexpectedly high results for RBC, HCT, PLT and MPV without instrument generated messages, for the first run of a capped patient sample. Upon repeat analysis the results are correct. Patients could be affected as described below: (1) False high RBC and HCT may result in a delay of treatment, or the delivery of temporarily ineffective treatment, due to HCT 4.0 - 9.8% misleading effects on diagnoses for anemia, internal bleeding, Polycythemia Vera or dehydration; (2) False high PLT may cause permanent damage to patients with critically low PLT who require immediate corrective or prophylactic platelet transfusion; (3) A false high MPV is unlikely to affect immediate clinical assessment of a patient.

PRODUCT

UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). Recall # Z-1980-2011

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 20, 2010.Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

REASON:  Sharp edges on drawer slides within the DxH800 Floor Stand (Cabinet) may expose operators to physical injury while replacing reagents and waste containers. IMPACT: There is potential for exposure to blood borne pathogens such as HIV, HBV, and HCV.

PRODUCT:

Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009 The Maxi Sky 1000 is designed for lifting patients in a homecare setting, at nursing homes and other assisted living centers, as well as in institutional or hospital settings. Patient transferring is performed under the supervision of an appropriately trained caregiver staff, in accordance with the instructions for use. All other uses must be avoided. Recall # Z-1983-2011.

MANUFACTURER:  Arjo, Inc. dba ArjoHuntleigh, Addison, IL, byletter dated March 4, 2011.Manufacturer: B.h.m. Medical, Inc., Magog Quebec, Canada. Firm initiated recall is ongoing.

REASON:  The battery-powered control board in the ceiling lift motor may overheat, resulting in smoke and possibly flames and the lift becoming inoperable.

PRODUCT:

1. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution, Femoral and Provisional Impactor/Extractor, REF 00-5901-026-00. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1985-2011; 
2. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Posterior Referencing Sizer, REF 00-5901-040-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1986-2011; 
3. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Posterior Referencing Sizer Boom, REF 00-5901-040-10, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1987-2011; 
4. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Patella Peg Drill Guide Handle, REF 00-5903-060-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1988-2011; 
5. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Quick-Connect Handle, REF 00-5901-034-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1989-2011; 
6. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Modular T-Handle, REF 00-5901-061-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1990-2011; 
7. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Extramedullary Distal Telescoping Tube, REF 00-5901-071-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1991-2011; 
8. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Extramedullary Proximal Telescping Rod, REF 00-5901-072-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1992-2011 
9. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Extramedullary Modular Spike Arm Post, REF 00-5901-074-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1993-2011; 
10. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Distal Femoral Resection Guide, REF 00-5901-063-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1994-2011; 
11. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Femoral Valgus Alignment Guide, REF 00-5901-067-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1995-2011; 
12. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Patella Clamp, REF 00-5901-067-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1996-2011; 
13. Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Patella Osteotomy Guide, REF 00-5903-010-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1997-2011

MANUFACTURER:  Zimmer Inc., Warsaw, IN, by letter dated March 14, 2011. Firm initiated recall is ongoing.  

REASON:  The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.

PRODUCT:

GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; list 13092-04-01. A stand-alone PC application for administration of medications specific to the GemStar Infuser. Recall # Z-1999-2011

MANUFACTURER:  Recalling Firm: Hospira Inc., Lake Forest, IL, letters dated March 23, 2011.Manufacturer: Hospira Inc., Morgan Hill, CA. Firm initiated recall is ongoing.

REASON:  The software enables programming of the GemStar device for a Bolus Lower Lockout Limit outside of the hard limits entered into the GemStar SP Infusion Suite Database PC application.

PRODUCT:

MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Recall #Z-2059-2011

MANUFACTURER:  Recalling Firm: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated March 10, 2011.

Manufacturer: Philips And Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning, China. Firm initiated recall is ongoing.

REASON:  The Philips MX 16-slice CT scanners are subject to recall/field correction due to a problem encountered with the units when using the 'Combine Viewing' Option. The firm determined that inaccurate dimension measurements display when using the Combine Viewing Option. Moreover, if the dimension measurements from merged images created using this option are used, there is a potential for applying inaccurate dimension information to patients, which could result in misdiagnosis.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 27, 2011.

CLASS II

PRODUCT:  
Penumbra brand Penumbra Coil System, Penumbra Coil 400. The Penumbra Coil System (Penumbra Coil 400 TM) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae. The coils are also intended for arterial and venous embolization in the peripheral vasculature. The coils function to selectively embolize aneurysms or targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Penumbra Coil System is compatible with the Penumbra PX 400 Micro catheter. Recall # Z-1906-2011

MANUFACTURER:..Penumbra Inc., Alameda, CA, by letter dated March 3, 2011. Firm initiated recall is complete.

REASON: The diameter of a component of the device is out of tolerance specification; the Delivery Pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the coil.

PRODUCT:
1) DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management. Recall #Z-1946-2011; 
2) DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing Product Code: 281103 Fluid Tissue Management. Recall # Z-1947-2011; 
3) DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) (International Distribution Only) Product Code: 281102 Fluid Tissue Management. Z-1948-2011

MANUFACTURER: Recalling Firm: DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, letter dated December 2, 2010.  
Manufacturer: COFAT, LA MARSA, Tunisia. Firm initiated recall is ongoing.

REASON: Product sterility may be compromised due to breach in sterile packaging.

PRODUCT:
Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent pack lots The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism. Recall # Z-1949-2011

MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated March 20, 2011.Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.

REASON: The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously low (20%) when measured using the Access Total T4 assay. Erroneously low results which are actually high (outside of the normal reference range) could mask hyperthyroidism. Failure to diagnose or treat hyperthyroid disease associated with pregnancy could result in serious, permanent harm to the fetus/neonate.

PRODUCT:  
ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.

MANUFACTURER: ArthroCare Corp., Sunnyvale, CA, by letters on September 30, 2011. Firm initiated recall is ongoing.

REASON: During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.

PRODUCT:  
Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy. Model number H83. Recall # Z-1957-2011

MANUFACTURER: Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on February 7, 2011. Firm initiated recall is ongoing.

REASON: An issue with the Varis Vision software where treatment can occur without the dynamic Multileaf Collimator component and may deliver a higher than expected dose of radiation.

PRODUCT :
Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuStar; and Pelton & Crane. Part number for the bolt: 022R065 Product is labeled in part: DCI Equipment, Mfg By: Dental Equipment, LLC. DC1235, Marus Dental, Mfg By: Dental Equipment, LLC. DC1490, DC1690, and DC1700, and DC1702, Pelton & Crane, Spirit SP17. Recall # Z-1958-2011

MANUFACTURER: Dental Equipment LLC, Newberg, OR,  by letter on March 8, 2011. Firm initiated recall is ongoing.

REASON: Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair.

PRODUCT:  
LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT Therapist system, as part of the ARTISTE And PRIMUS system. Electronic record management system as part of a linear accelerator system used to keep track of notes and database for oncology electronic medical records. Part numbers 8149259, 8164787, 8166527. Recall # Z-1970-2011

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter dated September 8, 2010.
Manufacturer: Impac Medical Systems Inc., Sunnyvale, CA. Firm initiated recall is complete.  

REASON: When editing the note type of a previously entered note, then reverting to the original type, data may be lost.

PRODUCT : 
1) SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S. Recall # Z-1981-2011; 
2) SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD. Recall # Z-1982-2011

MANUFACTURER: Recalling Firm: Hsmg, Inc., D/b/a Smartinfuser USA, Houston, TX, by e-mail and telephone on March 17, 2010.
Manufacturer: Medical Flow Systems, Ltd, Shlomi, Israel. Firm initiated recall is ongoing.

REASON: Elastomeric tube in product's compression unit has the potential to burst following filling.

PRODUCT:  
Magnetom Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging. Model numbers 10018165, 10018221, 10018222, 7387074, 7391167. Recall # Z-2021-2011

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated November 24, 2010,Manufacturer: Siemens Medical Solutions Inc., D-91056 Erlangen, Germany. Firm initiated recall is ongoing.

REASON: Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.

PRODUCT:
Siemens brand 550 TxT Patient Treatment Table, part number 7346534; The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to position the patient accurately according to the treatment plan for various radiation therapy treatment techniques. Recall # Z-2023-2011

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter dated March 21, 2010.  Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.

REASON: Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent.

PRODUCT:  
1) Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. Recall # Z-2040-2011;2) Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3 and Part numbers 9869-401-02401, 9869-401-02501, 9869-401-02601, 9869-401-02701, 9869-401-02801, 9869-401-02901. Recall # Z-2041-2011

MANUFACTURER: Gendex Dental Systems, Des Plaines, IL, by letter on February 4, 2011. Firm initiated recall is ongoing.

REASON: There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obvious these images cannot be used for diagnostic purposes

PRODUCT: : 
Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system. Catalog # PH-09806. Recall # Z-2048-2011

MANUFACTURER: Arrow International Inc., Reading, PA, by letter dated March 25, 2011. Firm initiated recall is ongoing.

REASON: Labeling discrepancy: The outer corrugate as well as a card inside the package state the product contains dry natural rubber – this is not duplicated on the unit packaging.

PRODUCT:
1) R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1): Primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, a vascular necrosis or traumatic arthritis. Recall # Z-2053-2011; 
2) R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, QTY (1). Recall # Z-2054-2011; 
3) R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 52 MM O.D., REF 71338952, STERILE R, QTY (1). Recall # Z-2055-2011;
4) R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, QTY (1). Recall # Z-2056-2011; 
5) R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE R, QTY (1). Recall # Z-2057-2011; 
6) R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, QTY (1). Recall # Z-2058-2011

MANUFACTURER: Recalling Firm: Smith & Nephew Inc., Memphis, TN, by e-mail and letter on March 11, 2011.Manufacturer: Smith & Nephew, Tuttlingen, Germany. FDA initiated recall is ongoing.

REASON: During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. This has the potential to result in lower than expected strength for the liners.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 20, 2011.

CLASS II

PRODUCT:
2380 MINI Hand-Held Tube Sealer Power Source (including a 23802000 Battery Pack) The Model 2380 Power Source is an instrument that generates RF power for making seals on tubing made of RF reactive thermoplastic materials typically used in blood banks, blood processing facilities and transfusion centers. Recall # Z-1899-2011

MANUFACTURER: Haemonetics Corp., Braintree, MA, by letter dated January 28, 2011. Firm initiated recall is ongoing.

REASON: Battery pack may have exposed wire becoming hot.

PRODUCT:    
Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461; The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. Recall # Z-1900-2011

MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on January 14, 2009. Firm initiated recall is complete.

REASON: The product has a software problem in which previous patient measurement data gets associated with another patient's image.

PRODUCT:
Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Recall # Z-1901-2011

MANUFACTURER: Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO, by letter dated March 14, 2011.  
MANUFACTURER: Gambro Lundia Ab - Disposables Division, Lund, Sweden. FDA initiated recall is ongoing.

REASON: Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure.

PRODUCT:    
Curvtek Eye Needle, 12 MM large, Stainless Steel Gamma Sterilized, PKG/3, Sterile. After the Curvtek device is used to drill a "C" shaped tunnel through the patient's bone, the device is used to pass suture through the tunnel so that soft tissue may be tied down directly onto the bone; Part Number 906764. Recall # Z-1903-2011

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated March 10, 2011. Firm initiated recall is ongoing.

REASON: The firm initiated a recall due to the discovery that the devices were not sterilized, as required, prior to distribution.

PRODUCT:
8V3c transducer used with the ACUSON SC2000 ultrasound system. 8V3c transducer model number 10433823; ACUSON SC2000 model number 10433816. High-density array transducer for pediatric and fetal echocardiography applications. Recall # Z-1907-
2011  

MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on February 4, 2011. Firm initiated recall is ongoing.

REASON: When using the 8V3c transducer in color mode, the derated Ispta 3 (Spatial Peak-Temporal Average Intensity) may exceed the limit stated in the instructions for use.

PRODUCT:    
1) SPIDER Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device. Model number: 9000020. Recall # Z-1909-2011; 
2) SPIDER ADVANCED Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device.Model number: 9000021. Recall # Z-1910-2011

MANUFACTURER: Transenterix, Inc., Morrisville, NC, by letter dated February 25, 2011. FDA initiated recall is ongoing.

REASON: Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.

PRODUCT:
Inflow/Outflow Cannula; Qty: 1; the inflow/outflow cannula is intended as a general purpose, concomitant suction and irrigation device for use in endoscopic surgeries. It will be used by orthopedic surgeons in arthroscopic knee and shoulder procedures as well as used in conjunction with the Stryker Flow Control Arthroscopy pump and with all 502-477-xxx scopes. The design included dual scope sheaths made of metal that offer two important features. First, it will separate the inflow irrigation to the operative site from the outflow irrigation out of the operative site. Second, the cannula will have a dual stopcock design that will separately control the inflow and outflow irrigation ports; Part number 747-031-650. Recall # Z-1927-2011

MANUFACTURER: Stryker Endoscopy, San Jose, CA, by memo dated March 8, 2011. Firm initiated recall is ongoing.

REASON: Insufficient cleaning instructions were included for the Inflow/outflow Cannula in the user manual.

PRODUCT :  
Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; Neonatal Software catalog number: 159700; Neonatal Option catalog number: 159187. Hamilton Medical Intended for use in the hospital and institutional environment where healthcare professionals provide patient care. Recall # Z-1928-2011

MANUFACTURER: Recalling Firm: Hamilton Medical Inc., Reno, NV, by letter on February 16, 2011. 
MANUFACTURER: Hamilton Medical AG, Bonaduz, Switzerland. Firm initiated recall is ongoing.

REASON: The adaptive volume/pressure regulation can be automatically and permanently reduced to PEEP + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator.

PRODUCT:    
GE the CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE Monitor B850 host processing unit running the CARESCAPE Monitoring platform software, a display with integrated keyboard and a frame for the insertion of parameter measurement modules. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader), additional modules and frames and software options. The new subsystems include a host processing unit (CPU), a 15 inch LCD display with an integrated keypad, 19 inch LCD display with an integrated keypad and touch panel interface, a five slot parameter module frame, a seven slot parameter module frame, a cabled remote control, a cabled remote keypad, and the CARESCAPE Monitoring platform software. Some of these new major subsystems include non-patient contact accessory items (e.g. cables and mounting hardware). The CARESCAPE Monitor B850 interfaces to a variety of existing physiological parameter measurement modules. In addition, the CARESCAPE Monitor B850 interfaces to a variety of existing OEM medical devices via the existing network infrastructure. The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SpO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI. Recall #Z-1929-2011

MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated February 25, 2011. 
MANUFACTURER: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.

REASON: GE Healthcare has become aware of potential safety issues associated with the CARESCAPE" Monitor B850 when Patient Data Module (PDM), Tram Acquisition Module (Tram), Patient Side Module (E-PSM or E-PSMP), E- MASIMO or E-(P)RE(S)TN modules or Bed-to-bed alarming feature is used. 1. When CARESCAPE Monitor B850 is used with the above listed modules, some SpO2 alarms may be delayed or missed. 2. When bed-to-bed alarm settings are done in the CARESCAPE Monitor B850 some alarm settings may be delayed or not changed as set by the clinician. 3. When Patient Data Module or TRAM module is used in transport, arrhythmia alarms may be missed under certain circumstances. 4. When CARESCAPE Monitor B850 is used with the Patient Data Module (PDM) with Masimo SpO2 technology, SpO2 Probe Off alarm may be missed.

PRODUCT :  
1) GE Healthcare, CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, EGG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. Recall # Z-1930-2011;
2) GE Healthcare, CARESCAPE Monitor B850 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, EGG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. Recall # Z-1931-2011

MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letters dated March 23, 2011.  
MANUFACTURER: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.

REASON: GE Healthcare has become aware of a potential safety issue associated with the CARESCAPE Monitor B650 & B850 Cardiac Output measurement using Patient Data Module (PDM), and activation of ECG Leads Off alarm in specific cases. 1. When the CARESCAPE Monitor is used to measure Cardiac Output values with the Patient Data Module (PDM) or TRAM Module, Cardiac Output values may be calculated incorrectly if the default catheter settings are used. This may lead to improper treatment. However, with user-defined catheter settings, the values are calculated correctly. 2. The ECG Leads Off alarm may not be activated with a specific user workflow. This can happen in a workflow where the user chooses to Update Lead Set in the ECG menu, but does not complete the ECG lead placement correctly. There will be a message of Lead Off shown within the monitor ECG waveform display to inform user of a missing lead. If the Lead Off error is not corrected and additional leads are removed or become disconnected, a complete loss of ECG monitoring can occur without activation of any Leads Off alarms. No injuries or illnesses reported.

PRODUCT:
 Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. a)) Catalog No. 270-2415; b) Catalog No. 270-2417. The Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin Alc Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II TURBO Hemoglobin Alc program is intended for Professional Use Only—For InVitro Diagnostic Use. Reagent Kit Information: The VARIANT II TURBO Hemoglobin Alc program utilizes principles of ionexchange high performance liquid chromatograpy (HPLC). The VARIANT II Hemoglobin Alc Program is based on chromatographic separation of HbAlc on a cation exchange cartridge. System Overview: The VARIANT II TURBO Hemoglobin testing System provides an integrated method for sample preparation, separation and the percent determination of percent Hemoglobin Alc in EDTA human whole blood. Technology Overview: The VARIANT II TURBO Hemoglobin Testing is a fully automated, high-throughput hemoglobin analyzer. It consists of two modules- the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT II TURBO System using Clinical Data Management (CDM) software. CDM is a dedicated software package of instrument control, data Control, results analysis, calibration, quality control and service software. Recall # Z-1932-2011

MANUFACTURER: Bio-Rad Laboratories Inc., Hercules, CA, by letter dated December 1, 2009. Firm initiated recall is ongoing.

REASON: Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping baseline can affect hemoglobin test results.

PRODUCT:
Rolko Adjustable (retractable) Strap and Handle, type TGN-R100GR; a component of a Lifting Pole, an accessory to long term care hospital beds such as ArjoHuntleigh's Minuet 2 Community bed and Enterprise series hospital beds; Lifting poles are accessories intended to assist patients in positioning themselves on a hospital bed and the lifting pole is used in conjunction with a strap and handle. The strap and handle hangs from the lifting pole and the patient grasps the handle to pull upon the strap when repositioning themselves. Recall # Z-1933-2011

MANUFACTURER: Recalling Firm: Arjo, Inc. dba ArjoHuntleigh, Addison, IL, by letter on February 24, 2011. 
MANUFACTURER: Rolko Kohlgruber Gmbh, Borgholzhausen, Germany. Firm initiated recall is ongoing

REASON: Part of the housing of the strap retracting mechanism built into the handle may break while the patient is using the handle and strap.

PRODUCT:    
1) Liquid Waste Bottle to store waste material from completed assays. Part Number 6769C. Recall # Z-1934-2011;
 2)Access Immunoassay Systems, Part Number 81600N & 81600N. An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids. Recall # Z-1935-2011;
 3)UniCel DxC 600i Access Immunoassay Systems, Part Number A25656. An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids. Recall # Z-1936-2011;
 4) SYNCHRON LxI 725 Access Clinical Systems, Part Number: 386200. An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids. Recall # Z-1937-2011

MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on October 5, 2010.
MANUFACTURER: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.

REASON: The recall was initiated because Beckman Coulter confirmed Access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. Over time, waste bottles can degrade, become brittle and potentially crack.

PRODUCT:    
1) Terumo Cardiovascular Systems Corp, CDI 101 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass. Recall # Z-1943-201;
2) Terumo Cardiovascular Systems Corp, CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass. Recall # Z-1944-2011

MANUFACTURER: Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letter on November 1, 2010. Firm initiated recall is ongoing.

REASON: Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.

PRODUCT:
Access Free T4 Calibrator, Part Number: 33885, The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Recall # Z-1945-2011  

MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, letter dated November 29, 2010.  
MANUFACTURER: Beckman Coulter, Inc., Chaska, MN. FDA initiated recall is ongoing.

REASON: The recall was initiated because the stability claim is not met. The affected T4 calibrator lot can produce quality control and patient results that are erroneously low (by greater than 2 standard deviations). An erroneously low patient result may lead to misdiagnosis and/or delayed treatment.

PRODUCT:
1) Coulter LH750 Analyzer The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. Part number: 6605632, A85570. Recall # Z-1953-2011;
2) Coulter LH780 Analyzer The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. Part number: 723585, A90728. Recall # Z-1954-2011;
3) Coulter LH500 Series System The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semi-automated reticulocyte analysis. Part numbers: 178832, 178833, 178834, A91062, A90994. Recall # Z-1955-2011;  
4) Coulter GEN's The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semi-automated reticulocyte analysis. Part numbers: 6605381, 6605381R, 6605381U. Recall # Z-1956-2011

MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated January 31, 2011.   
MANUFACTURER: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

REASON: This recall was initiated because Beckman Coulter identified a problem with some date fields that are transmitted to the Laboratory Information System (LIS). Starting Jan 1, 2011, the date fields will transmit as a blank field to the LIS if the year is greater than 2010. The following dates are affected: Run date, Control expiration date, Date of birth (For individuals born in 2011 or later), and Sample Drawn date. In addition to the date fields being blank, if the 1G1 transmission format is used, the following fields from the Retic Parameter group will not be transmitted. Information for three of these fields (RETTIME, RID and RCASS/POS) are, however, available in the General Information group when specimens are analyzed in the CR, CDR or R test modes. For samples that have been collated, one of the primary identifiers (RCASS/POS or RID) will be used to will match the information in the General Information group.

PRODUCT:    
Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system. Model numbers 10093864 and 7414803. Recall # Z-1959-2011

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter dated February 15, 2011.
MANUFACTURER: Siemens Medical Solutions Inc., D-91056 Erlangen, Germany. Firm initiated recall is ongoing.

REASON: During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all Axiom Aristos FX and FX Plus systems with serial numbers up to and including 1216. When using the detector alpha rotation, the detector may descend unexpectedly during movement or in vertical or table mode. If this occurs in vertical modes, the possibility exists that the detector may impact the patient's lower extremities.

PRODUCT :  
Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Sterile Convenience Packs/Modules; The affected lots of modules actually contain a 1 oz. tube of Non-Sterile Kendall Vaseline White Petroleum Jelly. Designed to assist hospitals in preparing for procedures by grouping all of the necessary components used for a procedure in one wrapper. Lube Jelly, 1 oz. tube, component catalog #8884430200, packaged in the following Presource Custom Sterile Convenience Packs/Modules: Cat #MBA33BULFF; Cat #MMA33SCLFD; Cat #PB45LVPHS; Cat #PB95GYWMH; Cat #PB95LSWM3; Cat #PB95VHWMK; Cat #PBCGOTCD2; Cat #PC42OHNK1; Cat #PCVACV60I; Cat #PCVMOHB66C; Cat #PGVMLPBJ3; Cat #PL23LICVJ; Cat #POVFMJAGP; Cat #PPV2CYWCF; Cat #PU24CCJMT; Cat #PU42CCTMC; Cat #PU42RPHCE; Cat #PU60PYMME; Cat #PUOCUSRCL; Cat #PUVMCCCHJ; Cat #PUVMGMCHL; Cat #PUVMPYBJZ; Cat #PV35OTSTACat #PV35OTSTB; Cat #SBA11CSMMB; Cat #SBA11CYHHC; Cat #SBA11CYOHG; Cat #SBA11CYRHH; Cat #SBA11CYSBM; Cat #SBA11LESLB; Cat #SBA11TUPDA; Cat #SBA12CYGTV; Cat #SBA12CYNMD; Cat #SBA12CYYHJ; Cat #SBA12MCROO; Cat #SBA13CCCOH; Cat #SBA13CTAMA; Cat #SBA13CYBSN; Cat #SBA13CYDHG; Cat #SBA13CYMEC; Cat #SBA13CYRWG; Cat #SBA14CYMSM; Cat #SBA18COFHD; Cat #SBA18PRSFM; Cat #SBA22CYBAL; Cat #SBA23BOUCF; Cat #SBA23CPWMC; Cat #SBA23CTMRE; Cat #SBA23CYDH1; Cat #SBA23CYDH2; Cat #SBA23CYNCF; Cat #SBA23ENPAF; Cat #SBA23RPVDB; Cat #SBA23RUDUG; Cat #SBA24CYNOA; Cat #SBA26CYSUH; Cat #SBA29TRSHE; Cat #SBA31CYMDD; Cat #SBA33CYDWI; Cat #SBA33CYVAA; Cat #SBA35CYBHH; Cat #SBA35CYSTF; Cat #SBA35GPBPD; Cat #SBA35GUMOI; Cat #SBA35MUSFF; Cat #SBA35STBLH; Cat #SBA35TPPHG; Cat #SBA35TRVSA; Cat #SBA35URBLK; Cat #SBA36CYAGI; Cat #SBA36CYRHB; Cat #SBA3DCPMME; Cat #SBA41CYWRC; Cat #SBA42CSVCJ; Cat #SBA45CYVHG; Cat #SBA48CYMHF; Cat #SBA53CYPHC; Cat #SBA69CYFSF; Cat #SBA7ACTPNB; Cat #SBAHDCYRVB; Cat #SBAHDRBRVC; Cat #SBAHDTUMJD; Cat #SBAHFTUMDA; Cat #SBAOCCYWHD; Cat #SID11SPSBC; Cat #SLC23RPUCI; Cat #SLC69VLWSB; Cat #SLC81RPBGD; Cat #SMA11CYPCF; Cat #SMA11DCNYO; Cat #SMA11LASBL; Cat #SMA11VGMME; Cat #SMA12CPMWP; Cat #SMA12CYAIF; Cat #SMA12HSROM; Cat #SMA12TIKGH; Cat #SMA12VHROI; Cat #SMA13BCNAE; Cat #SMA13DCWOE; Cat #SMA14VGOGI; Cat #SMA18CASFE; Cat #SMA23DCALB; Cat #SMA23LVMRK; Cat #SMA23TUMRK; Cat #SMA23VAMRR; Cat #SMA40DCBYA; Cat #SMA81HYNME; Cat #SOT41CPHNE; Cat #SOT48RPSEA; Cat #SRHHFGMMMB; Cat #SRHHFGMMMC; Cat #SRHHFNYMMD; Cat #SRHHFOCMMB; Cat #SRHHFTBMMC; Cat #SRICY0567H; Cat #SRICY0695M; Cat #SRICY0736T; Cat #SRIGS1342L; Cat #SUT81CPBGF. Recall # Z-1968-2011

MANUFACTURER: Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letter dated February 28, 2011. 
Manufacturers: Cardinal Health, Mc Gaw Park, IL;
Cardinal Health Medical Products and Services, Fort Mill, SC;
Convertors De Mexico, S.A. De C.V., Ciudad, Juarez, Mexico
Firm initiated recall is ongoing.

REASON: The Presource kits were assembled with non-sterile petroleum base lubricant instead of the labeled sterile water base lubricating jelly.

CLASS III

PRODUCT:
Zoll Auto Pulse Resuscitation System; Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs. Model 100; AutoPulse product number 8700-0700-xx AutoPulse 1.5G; AutoPulse Battery Part Number 8799-0702-xx. Recall # Z-1904-2011

MANUFACTURER: Zoll Circulation, Inc., Sunnyvale, CA, by telephone on January 28, 2009. Firm initiated recall is ongoing.

REASON: Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).

PRODUCT:
Quest MPS and MPS 2 Consoles. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery. Recall # Z-1924-2011

MANUFACTURER: Quest Medical, Inc., Allen, TX, by letter in July 2010. Firm initiated recall is ongoing.

REASON: User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.

PRODUCT :  
1) Inhibin A ELISA kit, Part Number: DSL-10-28100-4 The Inhibin A ELISA kit is intended for the quantitative measurement of Dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.Recall # Z-1925-2011;
2) Inhibin A ELISA kit, Part Number: DSL-10-28100T-4 The Inhibin A ELISA kit is intended for the quantitative measurement of Dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders. Recall # Z-1926-2011

MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated December 21, 2010.
MANUFACTURER: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.

REASON: The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 13, 2011.

CLASS I

PRODUCT:   
Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up to 50kVp. Recall # Z-1865-2011

MANUFACTURER: Xoft Inc., Sunnyvale, CA, by letter dated February 3, 2011. Firm initiated recall is ongoing.

REASON: Xoft Axxent Flexishield Mini product may shed particles identified as tungsten, and may look like suspicious calcifications on follow up scans if the product was used during Intraoperative radiation therapy.

PRODUCT:   
1) Curlin 6000 CMS Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1867-2011; 
2) Curlin 6000 IOD Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1868-2011; 
3) Curlin PainSmart Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1869-2011; 
4) Curlin PainSmart IOD Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1870-2011

MANUFACTURER: Zevex International, Inc., Salt Lake City, UT, by letter dated February 28, 2011.MANUFACTURER: Zevex International, Inc., Salt Lake City, UT. FDA initiated recall is ongoing.

REASON: Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.  

CLASS II

PRODUCT:   
1) Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 and Allura CV20. Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. Recall # Z-1368-2011; 
2) Allura XPER FD 20 and Allura CV20; Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura CV20. Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. Recall # Z-1369-2011

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated November 4, 2010.
MANUFACTURER: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.

REASON: Adjustment of the micro-switches in the footswitch used on the Philips cardiovascular X-ray systems was not implemented. If it is programmed for exposure, it is possible that after pressing the pedal on the footswitch it does not release itself. The patient may be exposed to X-ray longer than intended.

PRODUCT:   
Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E Advanced Fresenius Polysulfone. Intended for use as an artificial kidney system to the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration and hemodiafiltration. Recall # Z-1622-2011

MANUFACTURER: Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, by telephone and follow-up letter on February 16, 2011.
MANUFACTURER: Fresenius Medical Care, North America, Ogden, UT. Firm initiated recall is ongoing.

REASON: There is an increased risk of an internal blood leak.

PRODUCT:   
AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile. Recall # Z-1643-2011

MANUFACTURER: Recalling Firm: Depuy Orthopedics, Inc., Warsaw, IN, bytelephone onJanuary 12, 2011 and January 14, 2011.
MANUFACTURER: Symmetry Medical USA, Inc., Warsaw, IN. Firm initiated recall is ongoing.

REASON: The firm received a complaint that the cannula for the drill is not the same size at both ends. The drill is grabbing the guidewire and advancing and not allowing to finish reaming, resulting in the possibility of the guide wire progressing through and penetrating the acetabulum.

PRODUCT:   
Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein) a) Catalog numbers: 300-50, b) Catalog numbers: 300-55. OP-1 Putty is authorized by Federal law for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes. Recall # Z-1727-2011

MANUFACTURER: Stryker Biotech, Hopkinton, MA, by letter on October 15, 2010. Firm initiated recall is ongoing.

REASON: A change to the Preparation for Use section was identified where 2.5cc was replaced with 2cc-3cc volume and was not approved.

PRODUCT:   
Dimension(R) Creatinine Flex(R) Reagent Cartridges The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System. Catalog Number DF33A. Recall # Z-1729-2011

MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated December 2010. Firm initiated recall is ongoing.

REASON: Firm has confirmed the potential for falsely elevated creatinine results with specified CREA Flex(R) reagent cartridge lots when processing tests from a well that has been punctured. This issue may affect creatinine results for quality control (QC) and patient samples.

PRODUCT:   
Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay. The Stratus(R) CS Acute CareTM Troponin I method (CTNI) is an in vitro diagnostic test for the measurement of cardiac Troponin I in heparinized plasma. Cardiac Troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). Cardiac Troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes (ACS) with respect to their relative risk of mortality. Recall # Z-1732-2011

MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated December 2010. Firm initiated recall is ongoing.

REASON: Low frequency of non-repeatable falsely elevated CTNI results without an associated error message.

PRODUCT:  
Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured in France. The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. Recall # Z-1733-2011

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letters dated March 23, 2010 and a follow-up letter dated July 1, 2010.  Firm initiated recall is ongoing.

REASON: Abbott has determined that gain settings for the non-standard specimen types may not match the gain settings for the standard specimen type. There is the potential for impact to product performance.

PRODUCT:  
115V Blanketrol III a) Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V; b) CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer. Recall # Z-1817-2011

MANUFACTURER: Cincinnati Sub-Zero Products Inc., Cincinnati, OH, by letters  dated October 18, 2010. Firm initiated recall is ongoing.

REASON: The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations.

PRODUCT:   
Access Thyroglobulin Antibody II, Part Number: A32898 The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. Recall # Z-1818-2011

MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on January 26, 2011. 
MANUFACTURER: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.

REASON: The recall was initiated after Beckman Coulter confirmed customer reports of reagent pack to pack variability for the Access Thyroglobulin Antibody II (TgAb) reagent lot numbers identified in the recall. Erroneous results for patient and quality control samples can be generated. The Thyroglobulin Antibody II (TgAbII) reagent lots may produce: (1) Erroneously high TgAb results for both quality control and patient samples; (2) Erroneously low TgAb results when the affected pack is used to calibrate the assay, and quality control and patient samples are read from an unaffected pack. False high results could affect or delay diagnosis or treatment, including unnecessary additional diagnostic testing. False low results could affect or delay diagnosis or treatment, including delay in detection of thyroid cancer recurrence.

PRODUCT:   
Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace?? (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The EBW is also provided as a component of PET/CT and SPECT/CT systems, performing the same function as indicated above (also referred to as the NM EBW). Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. EBW and NM EBW. Recall # Z-1819-2011

MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated September 29, 2010. FDA initiated recall is ongoing.  

REASON: The firm determined that the functional analysis feature in the Comprehensive Cardiac Analysis (CCA) was displaying incorrect values on the polar fields. The calculated results for the myocardial wall thickening was incorrect in that the numbers displayed for "Wall Thickening" actually represent a reduction in wall thickness from ES to ED.

PRODUCT:   
The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes; Model #728231. Recall # Z-1820-2011

MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated January 31, 2011. FDA initiated recall is ongoing.

REASON: During the version 2.6 software upgrade, the system was not recalibrated with the infant phantom for the infant protocol.

PRODUCT:   
24k Arthroscopy Outflow/Suction Tubing Set***REF 24k100***Qty 1***MADE IN USA***Rx Only. For use in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures. Recall # Z-1821-2011

MANUFACTURER: Recalling Firm: Linvatec Corp., dba ConMed Linvatec, Largo, FL, by letter on/about September 13, 2010.
MANUFACTURER: Harmac Medical Products, Inc., Buffalo, NY. Firm initiated recall is ongoing.

REASON: The 24k100 Arthroscopy Outflow/Suction Tubing Set may have been incorrectly assembled and could potentially allow waste to enter the sterile field.

PRODUCT:   
Ossur Total Knee, Model Number: 2100 The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee designed for multi-speed ambulators, higher impact levels and heavier loads. Recall # Z-1822-2011

MANUFACTURER: Ossur Engineering, Inc., Albion, MI, by letter on February 11, 2011. Firm initiated recall is ongoing.

REASON: Some units of the Total Knee 2100 produced from October 19th, 2010 until January 21st 2011, contained back links that may compromise knee function prematurely.

PRODUCT:   
1) Phoenix x/ray analyser series. Phoenix x|ray analyser series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology. Recall # Z-1825-2011; 
2) Phoenix x/ray inspector series. Phoenix x|ray inspector series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology. Recall # Z-1826-2011; 
3) Phoenix x/ray v/tome/x series. Phoenix x|ray v|tome|x series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology. Recall # Z-1827-2011 
4) Phoenix x/ray nanotom series. Phoenix x|ray nanotom series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology. Recall # Z-1828-2011

MANUFACTURER: GE Inspection Technologies, LP, Lewistown, PA, by letter on March 16, 2009. Firm initiated recall is ongoing.

REASON: Some of the systems do not have a safety interlock on the service access panel. Although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. Also, some systems lack proper placement of a caution label and others do not have this label affixed.

PRODUCT:   
1) Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265, Sterile. The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine. Recall # Z-1829-2011; 
2) Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407-266, Sterile, Stryker Instruments, Kalamazoo, MI. The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine. Recall # Z-1830-2011

MANUFACTURER: Recalling Firm: Stryker Instruments Division of Stryker Corp., Kalamazoo, MI, by letter dated February 3, 2011.
MANUFACTURER: Stryker Instruments, Arroyo, PR. Firm initiated recall is ongoing

REASON: The firm received five complaints that the stylet did not fit down the cannula. The investigation revealed that the incorrect probe assembly was packaged for two DeKompressor part numbers with the lot number of 10214012.

PRODUCT:   
The enGenTM Laboratory Automation System consists of 3 main components including Instrument Management Subsystem (Instrument Manager), Automated Track Subsystem (TCAutomation) and Configuration File developed by Ortho-Clinical Diagnostics (OCD). The Instrument Manager is a Windows-based software product that operates on a Pentium-class (or higher) PC processor. The instrument management subsystem is capable of connectivity with clinical analyzers, a Laboratory Information Systems (LIS), barcode label printers and other third party devices. The TCAutomation is a pre-analytical and post-analytical sample management system. The configuration file enables operational support of the site specific layout and instrument selection. The VITROS 5, 1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric Immunoassay methods.) Recall # Z-1831-2011

MANUFACTURER: Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY, by letter dated January 27, 2011.    MANUFACTURER: Thermo Electron Oy, Vantaa, Finland. Firm initiated recall is ongoing.

REASON: A software anomaly that can occur with analyzers connected to the Bypass modules listed below on an enGen" Laboratory Automation System using TCAutomation" Software Version 3.1.1 and below. When this anomaly occurs, it is possible for a sample other than the intended sample to be aspirated, potentially leading to test results being assigned to the wrong patient without error notification.

PRODUCT:   
Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Also for anatomical structures and calculation packages that provide information that provide information to the clinician...for clinical diagnosis purposes. Recall # Z-1832-2011

MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on February 16, 2010. Firm initiated recall is ongoing. 

REASON: The images captured from the device may be erroneous.

PRODUCT:   
REF 32-485050 Vanguard Knee Instrumentation Microplasty Slidex Anterior/Posterior, Qty: 1; The guide is used for femoral sizing - Neutral or 3 degree femoral rotation feet are attached to the slidex AP sizing guide. Recall # Z-1833-2011

MANUFACTURER: Recalling firm: Biomet, Inc., Warsaw, IN, by letter dated February 11, 2011.  
Manufacturers: Sandvik Medical Solutions Ltd, Sheffield, United Kingdom;
Biomet U.K., Ltd., Bridgend, South Wales, United Kingdom.
Firm initiated recall is ongoing.

REASON: Biomet has initiated this action due to the scale on the stylus of the Vanguard MP Slldex AP Sizer being incorrect for this assembly resulting in the scale being out of position.

PRODUCT:   
Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system. a) Part No. 081239953, b) SPI Patch, Part No. 08164365. Recall # Z-1834-2011

MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letter beginning November 2009. Firm initiated recall is ongoing.

REASON: Software defect problem is repeatable.

 PRODUCT:   
Triathlon PKR Peg Drill, Catalog Number: 5650-4-512 (Size 1-2 Peg Drill); Catalog Number: 5650-4-536 (Size 3-6 Peg Drill); The Triathlon-PKR Knee System is indicated for primary partial knee resurfacing (PKR). This system utilizes two fixation pegs on the femoral component for fixation and alignment. To prepare for these features, a peg drill, drill guide, and drill through femoral trial are provided. The femoral Trial Drill Guide is attached to the Modular Handle and assembled into the holes on the articulation surface of the Femoral Trial. Using the appropriately sized Peg Drill (Small Drill for sizes 1-2, Large Drill for sizes 3-6), both holes are drilled. The Peg drill is advanced until the step on the drill makes contact with the front face of the Femoral Trial Drill Guide. Recall # Z-1835-2011

MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on February 9, 2011, and February 10, 2011. Firm initiated recall is ongoing.

REASON: Stryker Orthopaedics has identified a trend of complaints involving reports of the peg drill cold welding to the drill guide, causing the Peg Drill to cease functioning. If cold welding of these components occurs, the following potential patient and/or surgeon or surgical staff harms may result.

PRODUCT:   
1) ACUSON and SONOLINE Antares and Antares PE ultrasound systems at product versions 4.0 and 5.0 with cardiovascular options installed; ACUSON Antares 4.0 & 5.0: 10032747, 10037592, 10040728; ACUSON Antares PE 4.0 & 5.0: 10032746, 10037591, 10038202, 10040729; SONOLINE Antares 4.0 & 5.0: 05936518, 08653771, 10037593; Antares Cardio Options: 10036613, 10036588, 10036585, 10436250; The ACUSON Antare is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, Harmonic Imaging, or 3D/4D imaging on a FPD display. The Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes. Recall # Z-1836-2011; 
2) ACUSON S2000 ultrasound systems (all versions) with cardiovascular options installed; ACUSON S2000: 10041461; S2000 Cardio Option: 10041853; The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. The ACUSON S2000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Recall # Z-1837-2011; 
3) ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options installed; ACUSON X300: 10037409, 10132987, 10038837; SONOVISTA X300: 10133170; ACUSON X300 PE: 10348531, 10348532, 10348533; X300 Cardiovascular Options: 10133037, 10348777, 10349032, 10427797, 10427822 10427816, 10563788; The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. Recall # Z-1838-2011

MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on August 17, 2010. Firm initiated recall is ongoing.

REASON: There is an error in the estimation of mean pressure gradient in the Cardiac measurement package. The currently implemented calculation will result in an underestimation of the mean pressure gradient (PGmean) when estimated from a trace of the Doppler waveform of the stenotic flow.

PRODUCT:   
The VARIANT Sickle Cell Short Program ROM Card; The VARIANT Sickle Cell Short Program is designed as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography. For in vitro diagnostic use. a) Catalog number 270-0500, which contains ROM Card b) Catalog # 270-0507. Rom Card is included in kit Lot number 70000349 and 70000353. Recall # Z-1846-2011

MANUFACTURER: Bio-Rad Laboratories Inc., Hercules, CA, by letter dated April 22, 2010. Firm initiated recall is ongoing.

REASON: The presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of Version 80300-S.

PRODUCT:   
BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton. The BD Phoenix Automated Microbiology System is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The Phoenix system provides results for most aerobic and facultative anaerobic Gram negative bacteria of human origin with the use of the NMIC/ID-123 panel type. Recall # Z-1847-2011

MANUFACTURER: Becton, Dickinson and Co., Sparks, MD, by letter dated January 28, 2011. Firm initiated recall is ongoing.

REASON: In vitro diagnostic test kit is defective and may cause false positive or false negative results.

PRODUCT:   
HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corporation The Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary and venous whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility and is not intended for home use. Recall # Z-1854-2011

MANUFACTURER: ITC-Nexus Dx, Inc., Edison, NJ, by letter dated January 21, 2011. Firm initiated recall is ongoing.

REASON: ITC has determined that results obtained using certain lots of Hgb Pro Professional Hemoglobin Test Strips may differ from results obtained using a reference hemoglobin testing system
.

PRODUCT:   
Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; The Xcelerate patella milling system (as detailed in surgical protocol LSPK35) was designed to prepare a patella to accept all Scorpio or Duracon patellar implants using either a resurfacing or recessed technique. Recall # Z-1862-2011

MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated January 27, 2011. Firm initiated recall is ongoing.

REASON: Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in a nominal condition) patella bone.

PRODUCT:   
1) a) Cardiac Marker Control Level 1, List Number 136601-06F12-02; b) Cardiac Marker Control Level 2, List number 136602/06F13-02; and 3) Cardiac Marker Control Level 3, List number 136603/06F14-02. Used to verify the integrity of newly received i-STAT cTnI cartridges. Recall # Z-1863-2011; 
2) Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02. Used to verify the accuracy of results over the measurement range of the i-STAT cTnI test. Recall # Z-1864-2011;

MANUFACTURER: Abbott Point Of Care Inc., Princeton, NJ, by letters on December 17, 2010. Firm initiated recall is ongoing.

REASON: Presence of CO2 in the head space of the vial can result in the generation of high results in Cardiac Marker Control Level 1, 2, and 3 which is used along with the Cardiac Marker Control Calibration Verification Set

PRODUCT:   
CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7 The device is used to cover and protect wounds. Recall # Z-1875-2011

MANUFACTURER: Pharmaplast S.A.E., Kafr El Zayat, Gharbia, Egypt, by telephone on February 17, 2011 and letter dated February 21, 2011. Firm initiated recall is complete.

REASON: The bandages are labeled as sterile, but failed sterility testing.

PRODUCT:   
1) CYTO-STAT? tetraCHROME" CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number: 6607013 Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5Al. Recall # Z-1876-2011; 
2) CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number: 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5Al. Recall # Z-1877-2011

MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated September 27, 2010. 
MANUFACTURER: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

REASON: A labeling error resulted in the specimen age stability and the prepared sample stability being stated incorrectly in the instructions for use. There is no impact to the product safety or functionality.

PRODUCT:   
1) King System , King LTSD Kit Size 4, non-sterile, REF KLTSD414. Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway. Recall: Z-1878-2011; 
2) King System , King LTS-D Kit Size 5, Sterile, REF KLTSD405. Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway. Recall # Z-1879-2011

MANUFACTURER: Recalling Firm: King Systems, Noblesville, IN, by letter dated January 24, 2011.
MANUFACTURER: Bates Industries, LLC, South Glens Falls, NY. Firm initiated recall is ongoing.

REASON: The products were below the specification for hardness. This could contribute to a higher incidence of problems during the insertion and final positioning of the airway in the patient. In rare instances the softness of the tube could cause the tube to fold over.

PRODUCT:   
Pouch/Carton Label: REF 5023-138***9.5 x 25.5 x 0.4mm***Qty 1***Micro Sagittal Blade, Fine***Sterile***Rx Only*** Made in USA*** To cut soft tissue or bone. Recall Z-1880-2011

MANUFACTURER: Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letter dated November 30, 2010. Firm initiated recall is ongoing.

REASON: Some units of Micro Sagittal Blade, Fine from Lot 180209 may have compromised seals in the sterile packaging.

PRODUCT :  
1) iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92; iSite PACS: iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems. Recall # Z-1881-2011
2) iSite PACS with iSite ViewForum Applications, R7.4V6 L1 L2, L3, Versions: 3.6.96, 3.6.101, 3.6.110, 4.1.96, 4.1.101, and 4.1.110; ViewForum Applications: iSite ViewForum Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. iSite ViewForum Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. iSite ViewForum Applications performs viewing, image manipulation, communication, printing, and quantification of images. Recall # Z-1882-2011

MANUFACTURER: Recalling Firm: Philips Medical Systems, Foster City, CA, by letter dated February 23, 2011.
MANUFACTURER: Philips Healthcare Informatics, Inc., Foster City, CA. Firm initiated recall is ongoing.

REASON: A software anomaly that occurs when clinicians use Volume Vision to view images in 3D and uses the measurement tool to measure regions of interest. This could lead to an incorrect interpretation of the measurements which could cause an incorrect diagnosis and incorrect treatment plan.

PRODUCT:   
MDI(R), S.A.L.T. Airway Device, Supraglottic Airway Laryngopharyngeal Tube, Intended for use with 6.5mm -9.00mm ET tubes, Including SALT(TM) airway, ET tube clamp, Latex-free securing strap, Tongue blade, Lubricating jelly, NON STERILE, REF 79-580, Manufactured in the Dominican Republic of U.S. Materials Supraglottic Airway Laryngopharyngeal Tube which can be used to facilitate blind, endotracheal intubation. Recall # Z-1885-2011

MANUFACTURER: Recalling Firm: Microtek Medical Inc., Columbus, MS, by letter dated January 17, 2011.
MANUFACTURER: Microtek Dominican, S.A., La Romana, Dominican Republic. Firm initiated recall is ongoing.

REASON: Product contains Triad Lubricating Jelly which was recalled.

PRODUCT:   
Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the monitor suspension arm to allow Customers to attach other medical devices, such as non-STERIS monitors, camera or other compatible items in place of the STERIS monitor. The Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The device is intended to be used by surgeons and other medical care practitioners in a surgical setting. Recall # Z-1886-2011

MANUFACTURER: Recalling Firm: Steris Corp., Mentor, OH, by letter dated February 18, 2011.
MANUFACTURER: Steris Corp., Montgomery, AL. Firm initiated recall is ongoing.

REASON: The arm adapter does not contain labeling specifying the applicable weight and moment limitations of the arm adapter.

PRODUCT:   
1) Face Tent with 15 mm Adapter, REF MD126. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. Recall # Z-1887-2011; 
2) Face Tent with 15 mm Adapter, REF S-MD126. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. Recall # Z-1888-2011; 
3) Aerosol Mask with 15 mm Adapter, REF MD127. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. Recall # Z-1889-2011; 
4) Aerosol mask with 15 mm adapter, REF S-MD127. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. Recall # Z-1890-2011 
5) Universal F2 Anesthesia Breathing Circuit, REF 5D440-61X-17. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. Recall # Z-1891-2011; 
6) Universal F Anesthesia Breathing Circuit, REF 5U345-611XB. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. Recall # Z-1892-2011

MANUFACTURER: Recalling Firm: King Systems Corp., Noblesville, IN, by letter dated January 24, 2011.
MANUFACTURER: Unomedical A Convatec Com., Hidalgo, TX. Firm initiated recall is ongoing.

REASON: The firm is conducting a subrecall of facetent masks because the masks could have a sticky substance on the inside or outside of the mask that may manifest itself 6-8 months after the manufacture date of the product. The sticky substance could result in inconvenience or in some remote cases cause patient harm.

PRODUCT:   
REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use*** Catalog No Product VPN6528 Articulating Arm, Secondary Flat Panel. 690-0024-00 Arm, Wall Mount, Flat Screen, GCX For mounting and positioning of flat screen monitors. Recall # Z-1893-2011

MANUFACTURER: Recalling Firm: Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letter on September 17, 2010.
MANUFACTURER: Gcx Corp., Petaluma, CA. Firm initiated recall is ongoing.

REASON: If the VHM Arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement

PRODUCT:   
BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a variety of ophthalmic surgery. Product is a cataract surgery knife designed for optimal tunnel architecture. Recall # Z-1894-2011

MANUFACTURER: Beaver-Visitec International Inc., Waltham, MA, by letter dated February 25, 2011. Firm initiated recall is ongoing.

REASON: Loose blades in the handle of knives due to uncured epoxy.

PRODUCT:   
Coulter PrepPlus 2 (part # 378600) is a microprocessor-controlled pipetting and diluting system. PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. The PrepPlus 2 is a compact, fully automated sample work station which can be programmed to perform a wide variety of liquid handling operations where volumes required range from 5 uL to 1000 uL. Recall # Z-1895-2011

MANUFACTURER: Beckman Coulter Inc., Brea, CA, by letter dated January 18, 2011. Firm initiated recall is ongoing.  

REASON: The recall was initiated after erroneous, though potentially credible; results due to intermittent reagent level sense failures could be generated. During these failures, the instrument fails to produce a warning that a reagent vial is low or out of reagent. The low or absent levels of reagent used during these failures may lead to insufficient antibody being dispensed into a daughter tube thereby generating an erroneous result. Erroneous results may lead to misdiagnosis, inappropriate testing, and/or delayed treatment of patients.

PRODUCT:   
1) Rusch Irrigation Tray w/Piston Catalogue Number 67890 For irrigation according to institutional guidelines. Recall # Z-1896-2011; 
2) Rusch Irrigation Tray w/Bulb, Catalogue Number 68895. For irrigation according to institutional guidelines. Recall # Z-1897-2011

MANUFACTURER: Teleflex Medical, Durham, NC, by letters dated February 24, 2011 and March 30, 2011.
MANUFACTURER: Medikmark, Inc., Waukegan, IL. FDA initiated recall is ongoing.

REASON: The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination.

PRODUCT:   
Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert. Integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. Model Number(s): 270-2417 (Kit), with 270-2420 (Cartridge set) Code(s): LCP Listing Number(s): DO48707 for CDM 3.6T software. Recall # Z-1898-2011

MANUFACTURER: Bio-Rad Laboratories Inc., Hercules, CA, by letter dated November 29, 2009. Firm initiated recall is ongoing.

REASON: Wrong lot number was found on the Hemoglobin Cartridge Insert. The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD.

PRODUCT:   
ARIA versions 8.0 and 8.1. The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provided tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information. Model number: HIT-INFSYS. Recall # Z-1905-2011

MANUFACTURER: Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated February 18, 2011. Firm initiated recall is ongoing.

REASON: An anomaly was identified in the ARIA version 8.0 and 8.1, when an image sequence template is added to a field in RT chart and a CIAO (Completely Irradiated Aperture Opening) is calculated, the resulting CIAO display at 4DITC may be incorrect.

PRODUCT:   
1) Penner Manufacturing Patient Transfer/Lift System, Cascade Transfer, Models: a) 380000-1 (white) and b) 380000-2 (gray). For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1911-2011; 
2) Penner Manufacturing Transfer Electric Cascade Patient Transfer/Lift System, Models: a) 382000-1 (right entry) and b) 382000-1L (left entry). For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1912-2011; 
3) Penner Manufacturing Bariatric Patient Transfer/Lift System, Cascade Transfer, Models 382500-1 (right entry). For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1913-2011; 
4) Penner Manufacturing Transfer Electric Cascade with Scale, Patient Transfer/Lift System, Models: a) 383000-1 (right entry) and b) 383000-1L (left entry). For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1914-2011; 
5) Penner Manufacturing Transfer Electric Bariatric with Scale, Patient Transfer/Lift System, Cascade Transfer, Models 383500-1 (right entry with scale). For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1915-2011; 
6) Penner Manufacturing Transfer Electric Superior right entry, Patient Transfer/Lift System, Models 384000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1916-2011; 
7) Penner Manufacturing Transfer Electric Superior left entry, Patient Transfer/Lift System, Models 385000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1917-2011; 
8) Penner Manufacturing Transfer Electric Superior end entry, Patient Transfer/Lift System, Models 386000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1918-2011; 
9) Penner Manufacturing Transfer Electric Superior right entry with scale, Patient Transfer/Lift System, Models 387000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1919-2011; 
10) Penner Manufacturing Transfer Electric Superior left entry with scale, Patient Transfer/Lift System, Models 388000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1920-2011; 
11) Penner Manufacturing Transfer Electric Superior end entry with scale, Patient Transfer/Lift System, Models 389000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1921-2011; 
12) Penner Manufacturing Transfer Electric Pacific Chair, Patient Transfer/Lift System, Models 393000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1922-2011; 
13) Penner Manufacturing Transfer Electric Pacific Chair with scale, Patient Transfer/Lift System, Models 394000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1923-2011

MANUFACTURER: Penner Mfg Inc., Aurora, NE, by letter on January 19, 2009. Firm initiated recall is complete.

REASON: Incomplete weld on the pillar mounting bracket.

CLASS III
PRODUCT   
10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709. This cable is used to connect an Auto 10 10-pole catheter to an EP recording system. Recall # Z-1839-2011

MANUFACTURER: Recalling Firm: Biosense Webster, Inc., Irwindale, CA, by letter dated March 16, 2011.
MANUFACTURER: Biosense Webster Inc., Diamond Bar, CA. Firm initiated recall is ongoing

REASON: The recall was initiated because Biosense Webster has confirmed that there is an inaccessibility of electronic version of the instruction for use (e-IFU) for the "10 ft. Interface Cable, 10 Pin-Shielded Tip Pins to 12 Pin-Blue", catalog number D128709, through the J&J Gateway (ie, e-IFU website).

PRODUCT:  
Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient. Catalog number 65652-123; Product code 65652-124. Recall # Z-1852-2011

MANUFACTURER: Cardinal Health Inc., Dublin, OH, by letter on February 18, 2011.
MANUFACTURER: Cardinal Health PR 218 Inc., Anasco, PR. FDA initiated recall is ongoing.

REASON: In one lot of product, the label for the small version of the sock was improperly used for the larger version of the product.

PRODUCT:   
HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of cathetcannulae.film, ers or 10cm x 12.5 cm. Recall # Z-1866-2011

MANUFACTURER: Recalling Firm: Hartmann USA, Inc., Rock Hill, SC, by letter on February 11, 2011.
MANUFACTURER: Paul Hartmann AG, Heidenheim An Der Brenz, Germany. Firm initiated recall is ongoing.

REASON: Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10.

 The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 6, 2011.

CLASS I

PRODUCT:
1) Universal Insertion Tray Bundle, CV13530, Sterile. These kits are used for dressing changes. Recall # Z-1460-2011;
2) Central Line Dressing Change Tray, DT10020, Sterile. These kits are used for dressing changes. Recall # Z-1461-2011;
3) Dressing Change Tray for CVC & PICC Lines, DT12105, Sterile. These kits are used for dressing changes. Recall # Z-1462-2011;
4) Dressing Change Tray for Hickman & Dialysis Catheters, DT12110, Sterile. These kits are used for dressing changes. Recall # Z-1463-2011;
5) Dressing Change Tray, DT12770, Sterile. These kits are used for dressing changes. Recall # Z-1464-2011;
6) Dressing Change Tray, DT13650, Sterile. These kits are used for dressing changes. Recall # Z-1465-2011;
7) Central Line Dressing Change Tray, DT13850, Sterile. These kits are used for dressing changes. Recall # Z-1466-2011;
8) PICC/Central Line Dressing Change Tray, DT14675, Sterile. These kits are used for dressing changes. Recall # Z-1467-2011;
9) OUT-PATIENT Port Access Dressing Tray, DT14875, Sterile. These kits are used for dressing changes. Recall # Z-1468-2011;
10) IN-PATIENT Port Access Dressing Tray, DT14880, Sterile. These kits are used for dressing changes. Recall # Z-1469-2011;
11) Dressing Change Kit, DT15215, Sterile. These kits are used for dressing changes. Recall # Z-1470-2011;
12) Dressing Change Tray, DT5880A, Sterile. These kits are used for dressing changes. Recall # Z-1471-2011
MANUFACTURER: Recalling Firm: Centurion Medical Products Corp., Williamston, MI, by letter dated January 12, 2011. 
Manufacturer: Centurion Medical Products, Salisbury, NC;
Centurion Medical Products Corp., Yuma, AZ. Firm initiated recall is ongoing.
REASON: The firm is conducting a sub-recall of kits containing Triad Groups alcohol prep pads. Triad initiated a recall of prep pads due to a concern about potential contamination of the products with an objectional organism, Bacillus cereus.

PRODUCT:
Millar Sensors Systems. Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F. Provide intravascular pressure readings and capability for the deliverance of high-speed injection of radiopaque contrast media used in vascular imaging to selected sites in the vascular system. Recall # Z-1725-2011
MANUFACTURER: Millar Instruments, Inc., Houston, TX, by email on March 8, 2011. Firm initiated recall is ongoing.
REASON: Possibility of epoxy debris particles inside the catheter lumen.

CLASS II
PRODUCT:
GE Senographe Essential Full Field Mammography System (SENO ESSENTIAL) The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer. Recall # Z-1041-2011
MANUFACTURER: GE Healthcare, LLC, Waukesha, WI, by letter beginning January 19, 2011. Firm initiated recall is ongoing.
REASON: During installation it was discovered that the duplicate of the 21 CFR 1010 Certification label for the X-ray Generator Cabinet was missing from the installation kits that allow installation of the Senographe Essential in a van (mobile unit).

PRODUCT:
1) GE Senographe Essential Full Field Mammography System (Seno Essential) The expected usage of this product is for the same clinical applications as traditional mammographic film/screen systems. It generates mammographic images which can be used for screening and diagnosis of breast cancer. Recall # Z-1043-2011;
2) GE Senographe DS Full Field Mammography System Mammographic Film Screen System. Recall # # Z-1044-2011
MANUFACTURER: GE Healthcare, LLC, Waukesha WI, by letter beginning July 20, 2010. Firm initiated recall is ongoing.
REASON: It was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There is a potential that other X-ray tube covers are missing the rating plate.

PRODUCT:
1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of the internal structures of the head or body. The images produced by the signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Recall # Z-1424-2011;
2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information). Recall # Z-1425-2011;
3) Signa Advantage (K911959 Signa Advantage MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information). Recall # Z-1426-2011;
4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa® HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. Recall # Z-1427-2011;
5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems) Signa HDxt (K052293 Signa HDx and HDxt MR Systems ) The GE Signa® HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. Recall # Z-1428-2011;
6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T) Signa Excite, 12x (K041476 Signa Excite 1.5T and 3.0T) The GE Signa® HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. Recall # Z-1429-2011;
7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa OpenSpeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa 0.7T Signa OpenSpeed with Excite Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa 0.7T Signa OpenSpeed with Excite Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spinlattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Due to the open design of the system, the Signa 0.7T Signa OpenSpeed with Excite may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles. Recall # Z-1430-2011;
8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Signa 3.0T with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. Recall # Z-1431-2011;
9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology) Signa Infinity MR System with EXCITE (K013636 Signa Infinity MR System with EXCITE Technology) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. Recall # Z-1432-2011;
10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K103330) The Brivo MR355/ Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Brivo MR355/ Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. Recall # Z-1433-2011
MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated November 5, 2010.   
Manufacturers: GE Medical Systems LLC, Waukesha, WI;
Yokogawa Medical Systems, Ltd., Hino-Shi, Tokyo, Japan. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patient safety. If the gradient cables are inadvertently swapped while servicing the gradients and the Service Engineer does not perform the geometry check as required in the service procedure, images may be flipped left-right with incorrect orientation annotation.

PRODUCT:
GE Healthcare, ApexPro Telemetry System. The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered. The physiological parameters monitored include ECG, noninvasive blood pressure, non-invasive temperature and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro Telemetry System is also intended to provide physiologic data over the Unity Network to clinical information systems for display. Recall # Z-1522-2011
MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated December 29, 2010.
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of a potential for loss of patient monitoring when ApexPro Telemetry System is used in conjunction with a mirrored view CARESCAPE CIC Pro in combination monitoring mode (combo mode). The safety issue includes the potential for a delay in annunciation of audible alarms when used in combo mode, and may result in the delay of treatment of a cardiac event.

PRODUCT:
Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS Part Number 190713, 2008T Hemodialysis System with CDX Part Number 190766, 2008T Hemodialysis System with biBag The Fresenius 2008T is indicated for acute and chronic dialysis therapy. Recall # Z-1526-2011
MANUFACTURER: Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, by letter on January 19, 2011.
Manufacturer: Fresenius USA, Inc., Walnut Creek, CA. Firm initiated recall is ongoing.
REASON: Cursor on the dialysis screen may disappear and not respond to user input.

PRODUCT:
The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are authorized by a physician/medical director. In manual mode, the operator determines whether or not a defibrillation shock is needed by looking at the ECG rhythm display. Advisory mode can be useful during monitoring; CPSS (Continuous Patient Surveillance System) runs in the background and alerts the operator when a shockable rhythm is detected. Recall # Z-1548-2011

MANUFACTURER: Physio Control, Inc., Redmond, WA, by letter beginning October 1, 2010. Firm initiated recall is ongoing.
REASON: L1FEPAK 12 Operating Instructions that describe the process for disconnecting the device from AC (wall) power are not always being followed. When the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power, the service indicator will illuminate and the device may fail to charge the defibrillator and/or initiate pacing.

PRODUCT:
Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System. The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy. Recall # Z-1558-2011

MANUFACTURER: Medtronic Navigation, Inc., Louisville, CO, by letter dated December 22, 2010 nationwide and internationally on December 27, 2010. Firm initiated recall is ongoing.
REASON: Position Sensor Unit may generate tracking errors or may stop tracking immediately.

PRODUCT:
Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1) Intraoral X-Ray Systems. The wall mounting plate is used to install the Master Control unit of the X-ray system to two wooden wall studs spaced at 16", or to a wall supported by steel studs. Part numbers D800WPEXPERT, D800WP, EXPERTDC55 NAWP, EXPERTDC65 NAWP and EXPERTDC75 NAWP. Recall # Z-1559-2011
MANUFACTURER: Gendex Dental Systems, Des Plaines, IL, by letter dated December 20, 2010 and a revised letter dated January 20, 2011.  Firm initiated recall is ongoing.
REASON: The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate.

PRODUCT:
1) Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Ref TRS100SB. The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery. Recall # Z-1590-2011;
2) Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 mm, 1550 mL capacity; 3 units per box; Ref TRS175SB. The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery. Recall # Z-1591-2011
MANUFACTURER: Anchor Products Company, Inc., Addison, IL, by letter dated December 8, 2010. FDA initiated recall is ongoing.   
REASON: The metal component within the unit can break and cause a malfunction. Use of the device may represent a potential health hazard if the metal component is not removed after breakage.

PRODUCT:
1) Philips BV Libra, Mobile X-ray unit, 718022. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety surgical and non-surgical applications including; cerebral, thoracic, abdominal, peripheral, orthopedic, cardiac, and vascular procedures. Recall # Z-1603-2011;
2) Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. Recall # Z-1604-2011;
3) Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. Recall # Z-1605-2011
MANUFACTURER: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters dated January 5, 2011.  
Manufacturer: Philips Medical Systems Nederland’s, Best, Netherlands. Firm initiated recall is ongoing.
REASON: The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems.

PRODUCT:
CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. Recall # Z-1607-2011
MANUFACTURER: Civco Medical Instruments Inc., Kalona, IA, by telephone and e-mail letter dated January 21, 2011. Firm initiated recall is complete.
REASON: Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information.

PRODUCT:
ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-011. Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. During assembly of a construct, the Anti-Splay Cap locks onto the Screw Body to prevent the Screw Body tabs from splaying (spreading apart). The Anti-Splay Cap is subsequently removed from the Screw Body after assembly of the construct. The Anti-Splay Cap is a stainless steel machined instrument. The instrument is used within the Firebird Reduction Kit (Domestic, 44-9050) and the ICON Reduction Kit (International, 68-0010). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II. Recall # Z-1608-2011
MANUFACTURER: Recalling Firm: Orthofix Inc., Lewisville, TX, by letter dated October 22, 2010.  
Manufacturer: Blackstone Medical, Inc., Wayne, NJ. Firm initiated recall is ongoing
REASON: There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies.

PRODUCT:
Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. Used for the termination of ventricular tachycardia and ventricular fibrillation. Recall # Z-1609-2011
MANUFACTURER: Philips Healthcare Inc., Andover, MA, by letter on February 7, 2011. Firm initiated recall is ongoing.
REASON: Software: EtCO2 and Ventilation Rate values may be labeled incorrectly.

PRODUCT:
1) STA-Flex SUBTALAR SCREW, 7 mm x 13 mm, REF 982361, Sterile. Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function. Recall # Z-1612-2011;
2) STA-Flex SUBTALAR SCREW, 8 mm x 14 mm, REF 982362, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function. Recall # Z-1613-2011;
3) STA-Flex SUBTALAR SCREW, 9 mm x 15 mm, REF 982363, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function. Recall # Z-1614-2011;
4) STA-Flex SUBTALAR SCREW, 10 mm x 16 mm, REF 982364, Sterile. Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function. Recall # Z-1615-2011;
5) STA-Flex SUBTALAR SCREW, 11 mm x 17 mm, REF 982365, Sterile. Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function. Recall # Z-1616-2011;
6) STA-Flex SUBTALAR SCREW, 12 mm x 18 mm, REF 982366, Sterile. Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function. Recall # Z-1617-2011;
7) STA-Flex SUBTALAR SCREW, 13 mm x 19 mm, REF 982367, Sterile. Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function. Recall # Z-1618-2011
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated January 21, 2011. Firm initiated recall is ongoing.
REASON: The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.

PRODUCT:
GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number 442640; SYNCHRON and UniCel Systems and Part Numbers: Synchron LX20, Part Number: 466200, Synchron LX20 PRO, Part Number: 476100, Synchron LXI 725, Part Number: 476501, UniCel DxC 600, Part Number: A10405, UniCel 600 PRO, Part Number: A11810, UniCel DxC 600i, Part Number: A27318, UniCel DxC 800, Part Number: A11816, UniCel DxC 800 PRO, Part Number: A11812, UniCel DxC 880i, Part Number: A59102, UniCel DxC 660i, Part Number: A64871, UniCel DxC 680i, Part Number: A64903, UniCel DxC860i, Part Number: A64935 (1) The Synchron LX and UniCel DxC Synchron Clinical Systems are fully automated, computer controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (Sample type is chemistry dependent). (2) GLUCm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF). Recall # Z-1619-2011
MANUFACTURER: Beckman Coulter Inc., Brea, CA, by letter dated August 10, 2010. Firm initiated recall is ongoing.
REASON: The recall was initiated because Cartridge Glucose (GLU) on UniCel DxC and Synchron LX instruments may give falsely high results for moderately hemolysed samples. The Impact: (1) Neonatal samples drawn by lancets are more likely to be hemolysed to a degree sufficient to cause interference with glucose estimation and are a special at-risk population; (2) Other hemolysed samples may be similarly affected. Certain "precious" samples (e.g., spinal fluid) are more likely to be hemolysed, (3) Hemolysed samples can result in false high results that could affect or delay diagnosis or treatment, including insulin dosing and recognition of hypoglycemia.

PRODUCT:
1) AFP ELISA Kit; AFP ELISA kit (Extended range); Quantitative determination of AFP concentration in human serum. a) Catalog number: BC-1009; b) Catalog number: BC-1010. Recall # Z-1626-2011;
2) CEA ELISA Kit. Quantitative determination of AFP concentration in human serum. Catalog number: BC-1011. Recall # Z-1627-2011;
3) CA125 ELISA Kit. Quantitative determination of AFP concentration in human serum. Catalog number: BC-1013. Recall # Z-1628-2011;
4) CA15-3 ELISA Kit. Quantitative determination of AFP concentration in human serum. Catalog number: BC-1015. Recall # Z-1629-2011;
5) CA19-9 ELISA Kit. Quantitative determination of AFP concentration in human serum. Catalog number: BC-1017. Recall # Z-1630-2011;
6) PSA ELISA Kit. Quantitative determination of AFP concentration in human serum. Catalog number: BC-1019. Recall # Z-1631-2011;
7) Free PSA ELISA Kit. Quantitative determination of AFP concentration in human serum. Catalog number: BC-1021. Recall # Z-1632-2011;
8) Free beta-hCG ELISA kit. Quantitative determination of AFP concentration in human serum. Catalog number: BC-1023. Recall # Z-1633-2011;
9) Visual hCG ELISA kit. Quantitative determination of AFP concentration in human serum. Catalog number: BC-1045.  Recall # Z-1634-2011; 
10) H pylori IgG ELISA kit (Qualitative) H pylori IgG ELISA kit (Quantitive) H pylori IgG ELISA kit. Quantitative determination of AFP concentration in human serum. a)  Catalog number: BC-1051; Catalog number: BC-1052; c) Catalog number BC-1053.  Z-1635-2011;
11) Rubella IgG ELISA kit; Rubella IgM ELISA kit. Quantitative determination of AFP concentration in human serum. a)  Catalog number: BC-1081; b) BC-1083. Recall # Z-1636-2011;
12) Toxoplasma IgG ELISA kit; Toxoplasma IgM ELISA kit. Quantitative determination of AFP concentration in human serum. a) Catalog number: BC-1085; b) Catalog number BC-1087. Recall # Z-1637-2011;
13) CVM IgG ELISA kit; CVM IgM ELISA kit. Quantitative determination of AFP concentration in human serum. Catalog number: BC-1089; Catalog number BC-1091. Recall # Z-1638-2011;
14) HSV-1 IgG ELISA kit; HSV-1 IgM ELISA kit; Quantitative determination of AFP concentration in human serum. a) Catalog number: BC-1093; b) Catalog number BC-1095. Recall # Z-1639-2011;
15) HSV-2 IgG ELISA kit; HSV-2 IgM ELISA kit; Quantitative determination of AFP concentration in human serum. a) Catalog number: BC-1097: b) Catalog number BC-1099. Recall # Z-1640-2011;
16) CK-MB ELISA kit; Quantitative determination of AFP concentration in human serum. Catalog number: BC-1121. Recall # Z-1641-2011;
17) Myeloperoxidase (MPO) ELISA kit. Quantitative determination of AFP concentration in human serum. Catalog number: BC-1129. Recall # Z-1642-2011
MANUFACTURER: BioCheck Inc., Foster City, CA, by letter dated December 22, 2010. FDA initiated recall is ongoing.
REASON: Product labels indicate that the products are for IVD use and they do not have an approved 510(k).

PRODUCT:
BIO-RAD BioPlex 2200 Syphilis IgG Control Set. The BioPlex 2200 Syphilis IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis IgG Reagent Pack in the clinical laboratory. Catalog #: 663-1430. Recall # Z-1650-2011
MANUFACTURER: Bio-Rad Laboratories, Redmond, WA, by e-mail on November 23, 2010 and by letter on November 24, 2010. Firm initiated recall is ongoing.
REASON: An upward shift in the control values can result in a control value that falls outside of the current manufacturing ranges.

PRODUCT:
1) MagNA Pure LC 2.0 Instrument, catalog number 05197686001, MagNA Pure LC 2.0 instrument is a robotic instrument for automated isolation of nucleic acids (DNA, total RNA , total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96 well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for making of dilution series, reaction mixes. Recall # Z-1651-2011;
2) Factor II (prothrombin) G20210A kit, catalog number 03610195001. The Factor II (prothrombin) G20210A kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human factor II gene, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor II DNA recovered from clinical samples snd fluorigenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA. The Factor II (prothrombin) G20210A test is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation as an aide to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 instrument using the LightCycler Software 4.05 or 4.1. Recall # Z-1652-2011;
3) Factor V Leiden kit catalog number 03610179001. The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection of genotyping of the amplified Factor V DNA. The Factor V Leiden test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 Instrument using the LightCycler Software 4.05 or 4.1. Recall # Z-1653-2011
MANUFACTURER: Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated November 04, 2010. Firm initiated recall is ongoing.
REASON: If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct batch ID is still assigned to the batch in the data repository of the MPLC 2.0 software. This may result in sample mis identification. If printed from the ordering screens, the bar code is printed with the correct batch ID.  

PRODUCT:
Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource PBDS Modules; There is no label on the Esmark bandage in the Presource pack/module, Some are placed in Tyvek pouches and some are just loose in the pack, but neither have any labeling on them. The Esmark bandage is used to support and compress a part of the patient's body. Presource Packs/Modules are manufactured, according to customer requirements, for use during surgical procedures. The Esmark bandages were a component of the following Presource Convenience Packs/Modules: Cat #PO12AUGUT; Cat #PO12HNGUQ;  Cat #PO33FAPSF; Cat #PO53TKDMF; Cat #PO56TK48S; Cat #POMHTKWDI; Cat #POOCUEENK; Cat #SBA11PHSLG; Cat #SBA32VCPAQ; Cat #SBA32VEMEG; Cat #SBACGAAAUC; Cat #SBACZEXBRB; Cat #SCV15ACFSF; Cat #SOP08EPDMC; Cat SOP11APCPZ; Cat #SOP11ARNHT; Cat #SOP11ATMTI; Cat #SOP11BKRJG; Cat #SOP11ETCHA; Cat #SOP11EXMML; Cat #SOP11EXNYL; Cat #SOP11FASLD; Cat #SOP11FMLHN; Cat #SOP11FTJHK; Cat #SOP11FTSHO; Cat #SOP11HASWB; Cat #SOP11HDNSF; Cat #SOP11HNFHK; Cat #SOP11HNLDL; Cat #SOP11HNMOM; Cat #SOP11HNMUF; Cat #SOP11HNNBO; Cat #SOP11KAJEG; Cat #SOP11LXRJK; Cat #SOP11MAVUD; Cat #SOP11OASLE; Cat #SOP11OMICF; Cat #SOP11PDBPB; Cat #SOP11UPENH; Cat #SOP12ARKGN; Cat #SOP12ARMOD; Cat #SOP12HDCHL; Cat #SOP12MOVAF; Cat #SOP12ORKGJ; Cat #SOP13AROAN; Cat #SOP13ARXEH; Cat #SOP13FABOE; Cat #SOP13HABOD; Cat #SOP13HABSF; Cat #SOP13HAMGA; Cat #SOP13HNBIN; Cat #SOP13HNMGB; Cat #SOP13KNAOI; Cat #SOP13KNSHG; Cat #SOP13LEGLC; Cat #SOP13UEXEG; Cat #SOP14EXMSQ; Cat #SOP15AKFSG; Cat #SOP18ARCCE; Cat #SOP18ARMLC; Cat #SOP18EXGHF; Cat #SOP18EXSLG; Cat #SOP18HNMF; Cat #SOP18HNSFR; Cat #SOP18OMWBJ; Cat #SOP19EXFMM; Cat #SOP19FPSMB; Cat #SOP19KAEMD; Cat #SOP21KNSTB; Cat #SOP21TKHOC; Cat #SOP22FTSMP; Cat #SOP22KAMCI; Cat #SOP23ACBSA; Cat #SOP23ACUCO; Cat #SOP23APUCS; Cat #SOP23ARMZD; Cat #SOP23ATGMC; Cat #SOP23EXDUY; Cat #SOP23FTGME; Cat #SOP23HDVAI; Cat #SOP23HNRCQ; Cat #SOP23KTSMA; Cat #SOP23L1DUS; Cat #SOP23LMUCR; Cat #SOP23UPPCE; Cat #SOP23UXHWE; Cat #SOP24KAPSE; Cat #SOP29EXCFJ; Cat #SOP29HDUMA; Cat #SOP29HNMEC; Cat #SOP31ACOSI; Cat #SOP31AHSAE; Cat #SOP31ATMDD; Cat #SOP31EXLSD; Cat #SOP31EXNWL; Cat #SOP31EXRSG; Cat #SOP31EXSFT; Cat #SOP31EXSSF; Cat #SOP31HDCDI; Cat #SOP31HNEVU; Cat #SOP31HNSFU; Cat #SOP31KAMNH; Cat #SOP31KAOSO; Cat #SOP31KPEZB; Cat #SOP31PDJUA; Cat #SOP31RADGF; Cat #SOP31XTDSL; Cat #SOP32ATFSN; Cat #SOP32EXFCD; Cat #SOP32EXPAO; Cat #SOP32HARMI; Cat #SOP32HNMNN; Cat #SOP32HNWBO; Cat #SOP32KECYF; Cat #SOP32PDPCB; Cat #SOP32TKFSN; Cat #SOP32TKSAF; Cat #SOP33EXSFE; Cat #SOP33HDDWH; Cat #SOP34ACSTH; Cat #SOP34ARSKA; Cat #SOP34TJHCD; Cat #SOP35ARCRJ; Cat #SOP35HDSTI; Cat #SOP36ARAGQ; Cat #SOP36HACOD; Cat #SOP36HAFBQ; Cat #SOP36HNALR; Cat #SOP36KASRC; Cat #SOP36TKFBO; Cat #SOP36TNCAE; Cat #SOP3IKPIPD; Cat #SOP40PDDOG; Cat #SOP41HAMBC; Cat #SOP41HANSC; Cat #SOP41HFSUF; Cat #SOP41HNHMK; Cat #SOP41KNSOC; Cat #SOP41LEMBD; Cat #SOP41UEHMJ; Cat #SOP42HPKRD; Cat #SOP42KNKOD; Cat #SOP42MNKOM; Cat #SOP42PHOMK; Cat #SOP43ELLRB; Cat #SOP43KSLGF; Cat #SOP44HNSME; Cat #SOP44TKFSE; Cat #SOP44TKFSE; Cat #SOP45EXMKO; Cat #SOP45HNOCG; Cat #SOP45HPMVA; Cat #SOP48ACKAD; Cat #SOP48HPFAF; Cat #SOP48THLAA; Cat #SOP4AARNWC; Cat #SOP4AHASI1; Cat #SOP51ATSSC; Cat #SOP51EXDVG; Cat #SOP51LEMOG; Cat #SOP51XRKKB; Cat #SOP52FT73C; Cat #SOP53ARLEK; Cat #SOP53ETFOL; Cat #SOP53EXDCC; Cat #SOP53KNCCE; Cat #SOP53KNSLC; Cat #SOP53MHPRI; Cat #SOP53PPFRC; Cat #SOP54HDTCD; Cat #SOP54KAPRA; Cat #SOP55BCOKA; Cat #SOP56FTFOA; Cat #SOP56KN19R; Cat #SOP56KNSAQ; Cat #SOP56TKDCY; Cat #SOP57KNWGI; Cat #SOP59LXCPM; Cat #SOP59MNCHX; Cat #SOP5CAPGSC; Cat #SOP63KNSCL; Cat #SOP69AKPSB; Cat #SOP69FPEBB; Cat #SOP69OLFCC; Cat #SOP6NHDOIC; Cat #SOP73EXFSC; Cat #SOP73LOBDA; Cat #SOP73LXTCK; Cat #SOP73TKSJB; Cat #SOP7CEMBRD; Cat #SOP92ONSID; Cat #SOPBOKANFE; Cat #SOPCGCTAUA; Cat #SOPCGHNWMC; Cat #SOPCGKAAUA; Cat #SOPCGTKAUB; Cat #SOPHBKNBIC; Cat #SOPHDEXRVB; Cat #SOPOCACPAB; Cat #SOPOCBOMSA; Cat #SPP99HD1AA; Cat #SPP99KA2AA; Cat #SPP99PD1AA; Cat #SPP99TN1AA; Cat #SPP99TN3AA; Cat #SRH32STFGA; Cat #SRH73ACLSB; Cat #SRH73EXCCA; Cat #SRH73EXLSB; Cat #SRIOR0715Z; Cat #SUT69FBCPO. Recall # Z-1667-2011
MANUFACTURER: Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letter dated January 28, 2011.  
Manufacturer: Cardinal Health, Mc Gaw Park, IL;
Manufacturer: Cardinal Health Medical Products and Services, Fort Mill, SC;
Manufacturer: Convertors De Mexico, S.A. De C.V., Ciudad, Juarez, Mexico.
Firm initiated recall is ongoing.
REASON: Esmark bandages placed in some Presource kits/modules may not have been adequately sterilized.

PRODUCT:
Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. Recall # Z-1668-2011
MANUFACTURER: Recalling Firm: Abbott Laboratories, Santa Clara, CA, by letters on September 30, 2010. 
Manufacturer: Clinical Diagnostic Solutions, Plantation, FL. Firm initiated recall is ongoing.  
REASON: The product bar code label, when scanned, indicates that the volume is 10 mL rather than the correct volume of 10,000 mL. Analytical results are not impacted, although, there is a potential for delay in generating results.

PRODUCT:
1) Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190. For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers. Recall # Z-1679-2011;
2) Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322. For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers. Recall # Z-1680-2011
MANUFACTURER: Recalling Firm: Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated December 7, 2010.
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
REASON: The current product labeling for Acetaminophen does not provide specific interference information for bilirubin, hemoglobin or lipemia. Additional testing has been performed to quantify the impact of these interferences at different concentrations and different levels of acetaminophen. Low serum concentrations of acetaminophen were included in the study

PRODUCT:
Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use. Recall # Z-1685-2011
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated July 9, 2010. 
Manufacturers: Diagnostic System Laboratories Inc., Webster, TX;
Immunotech, Praha, Czech Republic.Firm initiated recall is ongoing.
REASON: Beckman Coulter has confirmed that eight Estrone RIA kit (Ref DSL 8700) lots are inaccurately calibrated to the firm's internal reference calibrator. Lots 992637, 100115A, 100205A, 100205RA, and 100226A have now expired and should not be in active use any more.

PRODUCT:
1) Liko Sabina EE Lift, Liko, Sweden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise. Recall # Z-1691-2011;
2) Liko Sabina II EE Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise. Recall # Z-1692-2011;
3) Liko Sabina EM Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise. Recall # Z-1693-2011;
4) Liko Sabina II EM Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise. Recall # Z-1694-2011;
5) Liko Sabina Comfort Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise. Recall # Z-1695-2011;
6) Liko Sabina 200 Lift. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise. Recall # Z-1696-2011;
7) Liko Capella 201 Lift. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise. Recall # Z-1697-2011
MANUFACTURER: Recalling Firm: Hill-Rom, Inc., Batesville, IN, by letters dated January 27, 2011 and a follow-up dated February 9, 2011.
Manufacturer: Liko AB, Lulea, Sweden. Firm initiated recall is ongoing.

REASON: The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports, two were injuries in patients during use and four injuries were in non-patients when they tripped over the lift device and fell on the unit

PRODUCT:
1) KING LT-D, SIZE 3, QUANTITY 1 EACH, Products with a Mission. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Recall # Z-1705-2011;
2) KING LTD, SIZE 4, QUANTITY 1 EACH, Products with a Mission, Size 4: Medium adult disposable oropharyngeal airway. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code 10-0003. Recall # Z-1706-2011;
3) KING LTD, SIZE 5, QUANTITY 1 EACH, Products with a Mission, Size 5: Large adult disposable oropharyngeal airway. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code 10-0004. Recall # Z-1707-2011;
4) KING LTS-D, SIZE 3, QUANTITY 5 EACH, Products with a Mission. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code 10-0025. Recall # Z-1708-2011;
5) KING LTS-D, SIZE 4, QUANTITY 5 EACH, Products with a Mission. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code 10-0026. Recall # Z-1709-2011;
6) KING LTS-D, SIZE 5, QUANTITY 5 EACH, Products with a Mission. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code 10-0027. Recall # Z-1710-2011;
7) CRQ423, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code CRQ423. Recall # Z-1711-2011;
8) CRQ424, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code CRQ424. Recall # Z-1712-2011;
9) CRQ425, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code CRQ425. Recall # Z-1713-2011;

10) KING SYSTEMS, A Consort Medical Company, KLTD212, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 2, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTD212. Recall # Z-1714-2011;
11) KING SYSTEMS, A Consort Medical Company, KLTD2125, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 2.5, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTD2125. Recall # Z-1715-2011;
12) KING SYSTEMS, A Consort Medical Company, KLTD213, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 3, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTD213. Recall # Z-1716-2011;
13) KING SYSTEMS, A Consort Medical Company, KLTD214, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 4, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTD214. Recall # Z-1717-2011
14) KING SYSTEMS, A Consort Medical Company, KLTD215, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 5, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTD215. Recall # Z-1718-2011;
15) KING SYSTEMS, A Consort Medical Company, KLTSD413, Quantity: 5 PER CASE, KING LTSD, KIT SIZE 3, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KTSD413. Recall # Z-1719-2011;
16) KING SYSTEMS, A Consort Medical Company, KLTSD414, Quantity: 5 PER CASE, KING LTSD, KIT SIZE 4, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTSD414. Recall # Z-1720-2011;
17) KING SYSTEMS, A Consort Medical Company, KLTSD415, Quantity: 5 PER CASE, KING KLTSD, KIT SIZE 5, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTSD415. Recall # Z-1721-2011
MANUFACTURER: King Systems Corp., Noblesville, IN, by letter dated January 14, 2011 and letter dated March 3, 2011. Firm initiated recall is ongoing.
REASON: The product may be "inadequately sterilized" and use of this product may result in "patient infection".
VOLUME OF PRODUCT IN COMMERCE
577,426 total airway kits

PRODUCT:
W Vital Health Pulsating Clean Rechargeable Toothbrush; Made in China; The toothbrush was sold with a single head and with three heads: a) Rechargeable Power Toothbrush - Model Number 565222, UPC 0 49022 35396 1; b) Rechargeable Power Toothbrush with 3 Replacement Heads: Model Number WIC 472641, UPC 0 49022 49612 5; Intended to remove adherent plaque and food debris from the teeth to reduce tooth decay. Recall # Z-1724-2011  
MANUFACTURER: Recalling Firm: Brushpoint Innovations, Inc., King City Ontario, Canada, by email dated January 7, 2011.
Manufacturer: Honglong Development Company of Zhuhai S.E.Z., Zhuhai, Guangdong, China. Firm initiated recall is ongoing.
REASON: The power toothbrush may make a loud noise and the battery cap becomes separated from the main body of the toothbrush. The battery cap can become a projectile that could cause potential injury if it comes in contact with the body.
VOLUME OF PRODUCT IN COMMERCE8,100 units

PRODUCT:
PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; The Bio-Rad PhD System is an EIA and IFA processing system that consists of a PhD fluid handling station(s) linked to a network computer via an Ethernet hub. The network computer provides worklist generation, data management, data reduction and microplate reader control functions. Recall # Z-1726-2011
MANUFACTURER: Bio-Rad Laboratories, Inc., Hercules, CA, by letter dated January 20, 2011.  Firm initiated recall is ongoing.
REASON: Firm's Correction involves advising customers who have implemented a Laboratory Information System (LIS) that they need to ensure quantitative results have passed all validation criteria prior to reporting patient results. When a patient result fails a Validation Rule, the qualitative result will indicate "INVALID".

PRODUCT:
Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation parameters. The software is used in conjunction with the following QIAGEN products: digene HC2 High-Risk HPV DNA Test [5199-1220 (one-plate); 5199-00016 (four-plate)] digene HC2 HPV DNA Test (5198-1220) digene HC2 CT/GC DNA Test (5130-1220) digene HC2 CT-ID DNA Test (5135-1220) digene HC2 GC-ID DNA Test (5140-1220) digene HC2 CT-GC Dual-ID DNA Test (5145-1220). a) hc2 User's Guide, and b) Qiagen embedded hc2 Software Suite 4.0. Recall # Z-1728-2011
REASON: The software component of a diagnostic medical device may be defective and could cause incorrect patient values.

PRODUCT:
1) Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader. Hematology Analyzers; Part Number: 6605522, 6605523, 6605524, 6605525, 6605526, 6605527, A85566, and A85564. Quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
Recall # Z-1730-2011;
2) Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader. Hematology Analyzers; Part Number: 6604569, 6604687, 6705995, 6705996, 6705997, 6705998, 6705999, and 6706000. Quantitative, automated, differential cell counters for in vitro diagnostic use. Recall # Z-1731-2011
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on December 14, 2010.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON: The recall was initiated because Beckman Coulter has confirmed the Coulter MAXM, MAXM AL, HmX and HmX AL Analyzers omit the tilde (~) character when the tilde is used as part of the Sample 10 within a barcode label scanned by the primary mode barcode reader. There is a potential for Specimen or Patient misidentification to occur.

PRODUCT:
1) UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R. The Tibial insert is a device that fits into the Tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure. Recall # Z-1740-2011;
2) CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R. The Tibial insert is a device that fits into the Tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure. Recall # Z-1741-2011;
3) UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R. The Tibial insert is a device that fits into the Tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure. Recall # Z-1742-2011
MANUFACTURER: Ortho Development Corp., Draper, UT, by letter dated January 7, 2011. Firm initiated recall is complete.
REASON: Components of a replacement knee system could be mislabeled.

PRODUCT:
SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is intended for quantitative determination of Rheumatoid Factor concentration in human serum or plasma. Z-1743-2011

MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated June 25, 2010.  
Manufacturer: Beckman Coulter Inc., Carlsbad, CA. Firm initiated recall is ongoing.
REASON: Product will not remain stable to the labeled expiration date.

PRODUCT:
ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy. In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma. Recall # Z-1744-2011
MANUFACTURER: Recalling Firm: Diasorin Inc., Stillwater, MN, by letter dated 19 August, 2010.  
Manufacturer: DiaSorin, S.p.A., Saluggia (VC), Italy. Firm initiated recall is ongoing.
REASON: The kit lots may not consistently exhibit stability to defined expiration dating, resulting in decreased binding and lower absorbance. Internal testing has confirmed that when defined assay validation criteria pass, analytical performance is consistent with package insert claims and patient results are accurate; therefore a review of previously reported results is not necessary.

PRODUCT:
1) ASR ACETABULAR IMPLANT 44, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800744. Recall # Z-1749-2011;  
2) ASR ACETABULAR IMPLANT 46, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat? porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800746. Recall # Z1750-2011;
3) ASR ACETABULAR IMPLANT 48, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat? porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800748. Recall # Z1751-2011;
4) ASR ACETABULAR IMPLANT 50, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat? porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800750. Recall # Z1752-2011;
 5) ASR ACETABULAR IMPLANT 52, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat? porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800752. Recall # Z1753-2011;
6) ASR ACETABULAR IMPLANT 54, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat? porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800754. Recall # Z1754-2011;
7) ASR ACETABULAR IMPLANT 56, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800756. Recall # Z1755-2011;
8) ASR ACETABULAR IMPLANT 58, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800758. Recall # Z1756-2011;
9)  ASR ACETABULAR IMPLANT 60, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800760. Recall # Z1757-2011;
10) ASR ACETABULAR IMPLANT 62, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800762. Recall Z1758-2011;
11) TOTAL ASR ACET IMP SIZE 64, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800764. Recall # Z1759-2011;
12)  TOTAL ASR ACET IMP SIZE 66, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800766. Recall # Z1760-2011;
13) TOTAL ASR ACET IMP SIZE 68, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800768. Recall # Z1761-2011;  
14) TOTAL ASR ACET IMP SIZE 70, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800770. Recall # Z1762-2011;
15) ASR FEMORAL IMPLANT SIZE 39, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile; The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890039. Recall # Z1763-2011;
16) TOTAL ASR FEM IMP SIZE 41, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use; Sterile. The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890041. Recall # Z1764-2011;
17) TOTAL ASR FEM IMP SIZE 43, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile; The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890043. Recall # Z1765-2011;
18) TOTAL ASR FEM IMP SIZE 45, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile. The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890045. Recall # Z1766-2011;
19) ASR FEMORAL IMPLANT SIZE 47, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile; The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890047. Recall # Z1767-2011;
20) ASR FEMORAL IMPLANT SIZE 49, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile; The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890049. Recall # Z1768-2011;
21) ASR FEMORAL IMPLANT SIZE 51, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile; The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890051. Recall # Z1769-2011;
22) ASR FEMORAL IMPLANT SIZE 53, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile; The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890053. Recall # Z1770-2011;
23) ASR FEMORAL IMPLANT SIZE 55, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile; The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890055. Recall # Z1771-2011;
24) ASR FEMORAL IMPLANT SIZE 57, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile; The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890057. Recall # Z1772-2011;
25) ASR FEMORAL IMPLANT SIZE 59, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile; The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890059. Recall # Z1773-2011; 
26) ASR FEMORAL IMPLANT SIZE 61, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile; The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890061. Recall # Z-1774-2011;
27) ASR FEMORAL IMPLANT SIZE 63, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile; The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable. Part Number 999890063. Recall # Z-1775-2011;
28) ASR UNI FEMORAL IMPL SIZE 39, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup,
a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima? Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890239. Recall # Z-1776-2011; 
29) ASR UNI FEMORAL IMPL SIZE 41, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima? Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890241. Recall # Z-1777-2011;
30) ASR UNI FEMORAL IMPL SIZE 43, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima? Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890243. Recall # Z-1778-2011;
31) ASR UNI FEMORAL IMPL SIZE 45, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima? Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890245. Recall # Z-1779-2011;
32) ASR UNI FEMORAL IMPL SIZE 46, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima? Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890246. Recall # Z-1780-2011;
33) ASR UNI FEMORAL IMPL SIZE 47, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima? Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890247. Recall # Z-1781-2011;
34) ASR UNI FEMORAL IMPL SIZE 49, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima? Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890249. Recall # Z-1782-2011;
35) ASR UNI FEMORAL IMPL SIZE 51, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima? Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890251. Recall # Z-1783-2011;
36)  ASR UNI FEMORAL IMPL SIZE 53, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima? Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890253. Recall # Z-1784-2011; 
37) ASR UNI FEMORAL IMPL SIZE 55, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima? Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890255. Recall # Z-1785-2011;
38) ASR TAP SLV ADAP 11/13 +0, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM-PRIMARY or ULTIMA* UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890340. Recall # Z-1786-2011;
39) ASR TAP SLV ADAP 11/13 +3, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890343. Recall # Z-1787-2011;
40) ASR TAP SLV ADAP 11/13 +6, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890346. Recall # Z-1788-2011;
41) ASR TAP SLV ADAP 11/13 +9, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999890349. Recall # Z-1789-2011;
42) ASR TAP SLV ADAP 12/14 +2, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, ASR MODULAR ACETABULAR CUP SYSTEM (TRADITIONAL) (A.K.A. ASR XL). The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800312. Recall Z-1790-2011;
43) ASR TAP SLV ADAP 12/14 +5, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, ASR MODULAR ACETABULAR CUP SYSTEM (TRADITIONAL) (A.K.A. ASR XL). The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800315. Recall # Z-1791-2011;
44) ASR TAP SLV ADAP 11/13 -3, DEPUY ASR TAPER SLEEVE ADAPTER, ASR MODULAR ACETABULAR CUP SYSTEM, TAPER SLEEVE ADAPTERS (SPECIAL). The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800333. Recall # Z-1792-2011;
45) ASR TAP SLV ADAP 12/14 -1, DEPUY ASR TAPER SLEEVE ADAPTER, ASR MODULAR ACETABULAR CUP SYSTEM, TAPER SLEEVE ADAPTERS (SPECIAL). The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800353. Recall # Z-1793-2011;
46) ASR TAP SLV ADAP 12/14 +8, DEPUY ASR MODULAR ACETABULAR CUP SYSTEM, ASR MODULAR ACETABULAR CUP SYSTEM (TRADITIONAL) (A.K.A. ASR XL). The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile; The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Part Number 999800318. Recall # Z-1794-2011;
47) ASR 300 Size 44, DEPUY ASR 300 ACETABULAR CUP SYSTEM. The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. Prescription Use, Sterile The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral components. Part Number 999830744. Recall # Z-1795-2011;
48) ASR 300 Size 46, DEPUY ASR 300 ACETABULAR CUP SYSTEM. The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. Prescription Use, Sterile; The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral components. Part Number 999830746. Recall # Z-1796-2011;
49) ASR 300 Size 48, DEPUY ASR 300 ACETABULAR CUP SYSTEM. The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. Prescription Use, Sterile; The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral components. Part Number 999830748. Recall # Z-1797-2011;
50) ASR 300 Size 50, DEPUY ASR 300 ACETABULAR CUP SYSTEM. The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. Prescription Use, Sterile The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral components. Part Number 999830750. Recall # Z-1798-2011;
51) ASR 300 Size 52, DEPUY ASR 300 ACETABULAR CUP SYSTEM. The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. Prescription Use, Sterile; The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral. Part Number 999830752. Recall # Z-1799-2011;
52) ASR 300 Size 54, DEPUY ASR 300 ACETABULAR CUP SYSTEM. The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. Prescription Use, Sterile; The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral components. Part Number 999830754. Recall # Z-1800-2011;
53) ASR 300 Size 56, DEPUY ASR 300 ACETABULAR CUP SYSTEM. The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. Prescription Use, Sterile The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral components. Part Number 999830756. Recall # Z-1801-2011;
54) ASR 300 Size 58, DEPUY ASR 300 ACETABULAR CUP SYSTEM. The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. Prescription Use, Sterile the DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral components. Part Number 999830758. Recall # Z-1802-2011;
55) ASR 300 Size 60, DEPUY ASR 300 ACETABULAR CUP SYSTEM. The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. Prescription Use, Sterile; The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral components. Part Number 999830760. Recall # Z-1803-2011;
56) ASR 300 Size 62, DEPUY ASR 300 ACETABULAR CUP SYSTEM. The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. Prescription Use, Sterile The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral components. Part Number 999830762, Size 62. Recall # Z-1804-2011;
57) ASR 300, Size 64, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application. Part Number 999830764. Recall # Z-1805-2011;
58) ASR 300, Size 66, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through
70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application. Part Number 999830766. Recall # Z-1806-2011;
59) ASR 300, Size 68, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application. Part Number 999830768. Recall # Z-1807-2011
60) ASR 300 Size 70, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application. Part Number 999830770. Recall # Z-1808-2011;
61) ASR ACETABULAR CUPS 64, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application. Part Number 999800764. Recall # Z-1809-2011;
62) ASR ACETABULAR CUPS 66, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application. Part Number 999800766. Recall # Z-1810-2011;
63) ASR ACETABULAR CUPS 68, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application. Part Number 999800768. Recall # Z-1811-2011;
64) ASR ACETABULAR CUPS 70, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application. Part Number 999800770. Recall # Z-1812-2011;
65) ASR UNI FEMORAL IMPL SIZE 57, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application. Part Number 999890257. Recall # Z-1813-2011;
66) ASR UNI FEMORAL IMPL SIZE 59, Part Number 999890259, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application. Recall # Z-1814-2011;
67) ASR UNI FEMORAL IMPL SIZE 61, Part Number 999890261. DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application. Recall # Z-1815-2011;
68) ASR UNI FEMORAL IMPL SIZE 63, DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. The DePuy ASR Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Modular Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Modular Acetabular Cups are indicated for cementless application. Part Number 999890263. Recall # Z-1816-2011

MANUFACTURER: Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by e-mail in March 2010.
Manufacturer: Depuy International Ltd., Leeds, United Kingdom. Firm initiated recall is ongoing.

REASON: As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the UK that demonstrated the ASR" System had a higher than expected revision rate at 8-9 percent at three years when used with smaller head sizes (less than 50 mm diameter). The overall revision rate for ASR continued to be in line with the class of metal-on-metal monoblock systems based on the data available to DePuy at that time. DePuy has just received new, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales. The data shows the five year revision rate for the ASR" Hip Resurfacing System is approximately 12 percent and for the ASR" XL Acetabular System is approximately 13 percent. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients. Because the new NJR data shows a higher than expected revision rate at five years, DePuy is issuing a voluntary recall of all ASR products. Reasons for revision identified within the datasets are consistent with those previously reported for ASR and include component loosening, component malalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain. Note: The DePuy ASR" Hip Resurfacing System was only approved for use outside the U.S. and the ASR" XL Acetabular System was available worldwide

PRODUCT:
1) Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322. For the in vitro quantitative determination of calcium in serum, plasma and urine. Recall # Z-1823-201;
2) Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190. For the in vitro quantitative determination of calcium in serum, plasma and urine. Recall # Recall # Z-1824-2011

MANUFACTURER: Recalling Firm: Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated October 11, 2010.
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.

REASON: The firm has received complaints of imprecision and erroneous patient results for calcium on the COBAS INTEGRA and COBAS c 501 system using reagent lots 62601901 and 63020401.

PRODUCT:
1) HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level. Recall # Z-1848-2011;
2) HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination. Recall # Z-1849-2011
MANUFACTURER: Recalling Firm: Hemo Cue, Inc., Cypress, CA, by letter dated October 7, 2010.
Manufacturer: Hemocue AB, Angelholm, Sweden Firm initiated recall is ongoing.
REASON: Incorrect configurations settings in software. As a result, certain error codes do not trigger appropriately. These error codes are: E01, E02 and E05 which are all related to the optronic performance of the analyzer. Possible incorrect results.

PRODUCT:
1) Pelton & Crane Spirit 3000 dental chair, Model #SP30, Catalog model #3003 and 3004. Recall # Z-1850-2011;
2) Pelton & Crane Spirit 1800 dental chair, Model #SP18, Catalog model #1802 and 1803. Recall # Z-1851-2011
MANUFACTURER: Pelton & Crane, Co., Charlotte, NC, by letter dated 3/04/2011. Firm initiated recall is ongoing.
REASON: The Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair.

PRODUCT:
Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0. Model numbers: 10032747, 10037592, 10040728; SONOLINE Antares: Model numbers: 5936518, 08653771, 10037593; ACUSON Antares PE: Model Numbers: 10032746, 10037591, 10038202, 10040729. Recall # Z-1853-2011
REASON: Image captured from the device may be erroneous.

CLASS III

PRODUCT:
Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units. The connectors are designed to be used for performing connections between tubes in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. BEQ-HG Connectors are to be used with MAQUET HLM Tubing sets. Recall # Z-1666-2011

MANUFACTURER: Recalling Firm: Maquet Cardiovascular, LLC, Wayne, NJ, by letter dated February 22, 2011.
Manufacturer: Maquet Cardiopulmonary Ag, Hirrlingen, Germany. Firm initiated recall is ongoing.

REASON: Tubing connectors incorrectly packaged and labeled.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 23, 2011.

CLASS I

PRODUCT:
1) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511046001. AC FLEXLINK PLUS 6MM CANNULA. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1480-2011;
2) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511054001. AC FLEXLINK PLUS 8MM CANNULA. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1481-2011;
3) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1482-2011;
4) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510970001. AC FLEXLINK PLUS INF 6/40 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1483-2011;
5) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510988001. AC FLEXLINK PLUS SET 6/70 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1484-2011;
6) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510961001. AC FLEXLINK PLUS SET 6/100 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1485-2011;
7) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511003001. AC FLEXLINK PLUS SET 8/40 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1486-2011;
8) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511020001. AC FLEXLINK PLUS SET 8/70 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1487-2011;
9) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510996001. AC FLEXLINK PLUS SET 8/100 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1488-2011;
10) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510945001. AC FLEXLINK PLUS SET 10/40 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1489-2011;
11) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510953001. AC FLEXLINK PLUS SET 10/70 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1490-2011;
12) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510937001. AC FLEXLINK PLUS SET 10/100 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1491-2011;
13) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511089001. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1492-2011

MANUFACTURER: Recalling Firm: Roche Insulin Delivery Systems Inc., Fishers, IN, by letters dated February 21, 2011.  

MANUFACTURER: Disetronic Medical Systems AG, Burgdorf, Switzerland. Firm initiated recall is ongoing.

REASON: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels

CLASS II

PRODUCT:
1) Applied Medical's Direct Drive Laparoscopic Clip Applier; Model Number: CA090; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1499-2011;
2) Applied Medical's GELPOINT LAP CHOLE KIT 2; Model Number: CK102 The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1500-2011;
3) Applied Medical's LAP CHOLE KIT 5 GK; Model Number: GK105 The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1501-2011;
4) Applied Medical's LAP CHOLE KIT 7 GK; Model Number: GK107 The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1502-2011;
5) Applied Medical's LAP CHOLE KIT 8 GK; Model Number: GK108 The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1503-2011;
6) Applied Medical's LAP CHOLE KIT 9 GK; Model Number: GK109-H The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1504-2011;
7) Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1505-2011;
8) Applied Medical's LAP CHOLE KIT; Model Number: K0491; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1506-2011;
9) Applied Medical's LAP CHOLE KIT; Model Number: K0492; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1507-2011;
10) Applied Medical's AM CHOLE KIT-TAM1; Model Number: K0509 The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1508-2011;
11) Applied Medical's LAP CHOLE KIT - 1A; Model Number: K0522; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1509-2011;
12) Applied Medical's LAP CHOLE KIT - BLADED; Model Number: K0552; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1510-2011;
13) Applied Medical's LAP CHOLE KIT; Model Number: K0630; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1511-2011;
14) Applied Medical's LAP CHOLE KIT; Model Number: K0684, The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1512-2011;
15) Applied Medical's LAP CHOLE KIT; Model Number: K2114; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1513-2011;
16) Applied Medical's PREMIUM DISPOSABLE LAP CHOLE KIT; Model Number: K2136. The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1514-2011;
17) Applied Medical's LAP CHOLE KIT; Model Number: K2154; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1515-2011;
18) Applied Medical's LAP CHOLE; Model Number: K2155; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1516-2011;
19) Applied Medical's KW/MOH LAP CHOLE KIT; Model Number: K2184; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1517-2011

MANUFACTURER: Applied Medical Resources Corp., Rancho Santa Margarita, CA, by letter dated September 10, 2010, and by Applied Medical on September 16, 2010. Firm initiated recall is complete.

REASON: Potential defect in the jaws, possibly resulting in jaw breakage.

PRODUCT:
MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management; Part # 10568605. Recall # Z-1572-2011

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on January 11, 2011.  

MANUFACTURER: Impac Medical Systems Inc., Sunnyvale, CA. Firm initiated recall is ongoing.

REASON: The potential for injury to a patient should the treatment data be incorrectly uploaded to patient records.

PRODUCT:
1) Plum A+ Single Channel Infusion Pumps; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - software version 11.3 d) list 20679 - Hospira MedNet Software e) list 20792 - Driver The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+ a convenient and cost-effective infusion system. Recall # Z-1644-2011;
2) Plum A+3 Triple Channel Infusion Pumps; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software Plum A+3 Triple Channel Infusion Pumps; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software. Recall # Z-1645-2011;
3) Plum A+ Hyperbaric Single Channel Infusion Pumps; list 11005 The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers. Recall # Z-1646-2011

REASON: Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues.

PRODUCT:
TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues. Recall # Z-1649-2011

MANUFACTURER: TomoTherapy Inc., Madison, WI, letter dated January 26, 2011. Firm initiated recall is ongoing.

REASON: It was determined that the Treatment Planning Station (TPS) can potentially under dose.

PRODUCT:
1) Philips Allura Xper Systems with Velara Generator, x-ray system. Recall # Z-1654-2011;
2) Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. Recall # Z-1655-2011;
3) Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. Recall # Z-1656-2011;
4) Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. Recall # Z-1657-2011

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters on October 15, 2010.

MANUFACTURER: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.

REASON: A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown.

PRODUCT:
Toshiba DUA-450F Kalare Radiographic Tilting Table. Recall # Z-1675-2011

MANUFACTURER: Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter dated July 8, 2010.

MANUFACTURER: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.

REASON: Top table lateral movement on their DUA-450F Kalare Table cannot be performed, or the table top lateral movement is performed at an extremely low speed. As a result, positioning of the patient cannot be performed by tabletop movement.

PRODUCT:
IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8; Catalog Number CM 60+ 00091915. Recall # Z-1676-2011

MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by letter dated February 10, 2011.

MANUFACTURER: AGFA healthcare Corp., Westerly, RI. Firm initiated recall is ongoing.

REASON: A discrepancy in the validation testing which resulted in the product not performing as intended.

PRODUCT:
Osteomatrix bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use. Recall # Z-1677-2011

MANUFACTURER: Biostructures, LLC, Newport Beach, CA, by email on June 15, 2010. Firm initiated recall is complete.

REASON: The OsteoMatrix Synthetic Bone Graft Composite Instructions for Use document, P4G10A/Rev. 01 had language that was not consistent with the cleared indications.

PRODUCT:
Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555. Recall # Z-1704-2011

MANUFACTURER: Recalling Firm: Stryker Endoscopy, San Jose, CA, by letters on February 25, 2010.

MANUFACTURER: Stryker Puerto Rico, LTD, Arroyo, Pr. Firm initiated recall is ongoing.

REASON: The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%).

CLASS III

PRODUCT:
LUCAS 2 Chest Compression System. Designed to uninterrupted chest compressions at a consistent rate and depth. Recall # Z-1664-2011

MANUFACTURER: Jolife AB, Lund, Sweden, by letter dated February 2011. Firm initiated recall is ongoing.

REASON: LUCAS 2 Chest Compression System may have malfunctions resulting from the failure of a hood probe on the device that connects to the battery. The device may stop in fail safe mode and the LEDs will start flickering or the device will switch off.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 16, 2011.

CLASS II

PRODUCT:
1) TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The TotalCare Bed Systems is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. Recall # Z-1563-2011;
2) VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface. The VersaCare Bed System is intended to provide a patient support suited to be used in healthcare environments. The VersaCare Bed may be used in such settings as acute care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). Recall # Z-1564-2011;
3) VersaCare P500 Microclimate Management Surface Upgrade Kits P3218A and P3219A Hill-rom Batesville, IN. The TotalCare Bed Systems is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. Recall # Z-1565-2011
MANUFACTURER: l-Rom, Inc., Batesville, IN, by letter dated February 21, 2011, Firm initiated recall is ongoing.
REASON: l-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the integrated P500 Microclimate Management (MCM) therapy surface, and with the VersaCare P500 MCM surface upgrade. Because of an unauthorized vendor part modification, it is possible that the MCM blower may not perform as originally designed. Given this modification, the MCM blower may experience the following: delayed start, slow running, or failure to operate. Patients may experience some reduced efficacy with managing skin temperature and moisture due to the reduced operation of the MCM blower. Please note that the mattress will continue to provide pressure redistribution to the patient, as the pump supplying air to the mattress bladders will continue to operate.

PRODUCT:
1) Terumo Advanced Perfusion System 1, 100/120V System 1 Base, REF 801763, Terumo Cardiovascular Systems Corp., Ann Arbor, MI. The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Recall # Z-1566-2011;2) Terumo Advanced Perfusion System 1, 220/240V System 1 Base, REF 801764, (not sold in the USA) The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Recall # Z-1567-2011
MANUFACTURER: Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter dated February 14, 2011. Firm initiated recall is ongoing.
REASON: Terumo Cardiovascular Systems (CVS) has received 19 reports of a circuit breaker for the Terumo Advanced Perfusion System 1 tripping and causing the system to switch to battery back-up power. In two cases, the incident was caused when the circuit breaker came into incidental contact with the base of an IV pole; in others there was no known cause. Terumo CVS' investigation has determined that the location and design of the circuit breakers (near the floor on the back of the base) contribute to the likelihood that a breaker can be inadvertently tripped by incidental contact with other equipment in close proximity.

PRODUCT:
Polycarbonate prescription single vision lenses for use in sport goggles. To be worn by a customer in a sport goggle frame to provide corrective refraction in accordance with the customer's prescription. Per the customer's request, some of the devices may also provide protection from bright sunlight. In the U.S., the Liberty Sport frame models and the corresponding SKU numbers into which the lenses at issue were inserted are: MaxMorpheus - 3703097, 3703105, 3703121, 3703139, 3703154, 3703162; Slam - 4286102, 4286103; Rec Spec Maxx - 1292931, 2102549, 2102549, 2102556, 2102564, 2102606, 2621068, 2621076, 2621084, 3300266, 3300274, 3300282, 3300332, 3300340, 3300357; Rec Spec Zone - 2102622, 3300407; Rec Spec Fusion - 2102655, 2102663, 3300373; Rec Spec Matrix - 1270439, 1278090, 1278089; Rec Spec HS2C - 1260789; Rec Spec 2003 - 1278092; Rec Spec Soft Touch - 1260791 In Canada, the Liberty Sport frame models and the corresponding SKU numbers into which the lenses at issue were inserted are: MaxMorpheus - 3703097, 3703162; Rec Spec Maxx - 2102549, 2102556, 2621068, 2621076, 3300381. Recall # Z-1568-2011

MANUFACTURER: Recalling Firm: Luxottica Optical Manufacturing, Mason, OH, by letters on June 30, 2010.Manufacturers: Luxottica Optical Manufacturing, Dallas, TX;
Luxottica, Memphis, TN;
Luxottica Optical, Knoxville, TN;
Luxottica Retail, Lockbourne, OH;
Luxottica North America D LLC; Winnipeg Manitoba, Canada.
Firm initiated recall is ongoing.

REASON: The polycarbonate prescription lenses may not meet the frame manufacturer's minimum lens thickness specification of 2.0 millimeters. LNAD made the decision to remove these sport goggles from the market because of the potential risk that the lenses could break or disengage from the frame in the event of an impact.

PRODUCT:
1) MONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014. Recall # Z-1569-2011;
2) MONOJECT Blood Collection Tubes containing heparin 10x50 Sodium Heparin Item code 8881320157. Recall # Z-1570-2011;
3) MONOJECT Blood Collection Tubes containing heparin 10x64 Sodium Heparin Item code 8881320256. Recall # Z-1571-2011

MANUFACTURER: Recalling Firm: Covidien LP, Mansfield, MA, by letter dated November 12, 2010.

MANUFACTURER: Covidien, LP, Norfolk, NB. FDA initiated recall is ongoing. 

REASON: The heparin sodium USP used to manufacture blood collection tubes was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.

PRODUCT:
1) Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-14010MLL, 14ga (2.1mm) x 10cm (10). Recall # Z-1573-2011;
2) Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm (10). Recall # Z-1574-2011;
3) Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10). Recall # Z-1575-2011;
4) Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10). Recall # Z-1576-2011;
5) Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm (10). Recall # Z-1577-2011

MANUFACTURER: Remington Medical Inc., Alpharetta, GA, by facsimile, email and certified mail starting February 7, 2011. Firm initiated recall is ongoing..

REASON: There is a potential for the needle hubs to break during use.

PRODUCT:
1) Biomet Innervue Disposable Scope Kit, 1.2MM, Part Number: 922140, Sterile. Recall # Z-1588-2011;
2) Biomet Innervue Disposable Scope Kit, 1.2MM with Cannula set. Part Number: 922141, Sterile. Recall # Z-1589-2011

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letters on February 10, 2011. Firm initiated recall is ongoing.

REASON: The cannula could not be connected to the scope and scopes disengage during use. The outer hub of Innervue scopes may become detached from the inner hub of the scopes during assembly of the scope to the Innervue hand piece. This condition may prevent the Innervue scope from being securely attached to the Innervue hand piece.

PRODUCT:
Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10. Recall # Z-1592-2011  

MANUFACTURER: Recalling Firm: Straumann Manufacturing Inc., Andover, MA, by letter dated September 30, 2010.
MANUFACTURER: Instituit Strauman, Basel, Switzerland. Firm initiated recall is ongoing.

REASON: Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.

PRODUCT:
ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850. The torque limiting T-handle is used with attachments and hex drivers for preparation of the femur and for locking screw insertion at specified torque limit in Arcos hip procedures. Recall # Z-1594-2011

MANUFACTURER: Recalling Firm: Biomet, Inc., Warsaw, IN, by telephone on January 28, 2011 and letter dated February 21, 2011.
MANUFACTURER: Symmetry Medical USA, Inc, Warsaw, IN. Firm initiated recall is ongoing.
REASON: The firm received two complaints of the tabs on the Torque Limiting T-Handle fracturing during surgery. The firm performed internal testing and found that the tabs may fracture when used in the “OFF” or “locked” setting for hand-reaming the femoral canal.

PRODUCT:
AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane North, Plymouth, MN 55442. The AMPLATZER Sizing Balloon II is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device. Z-1595-2011

MANUFACTURER: AGA Medical Corp., Plymouth, MN, by letter, dated December 17, 2010. Firm initiated recall is ongoing.

REASON
Mislabeled AMPLATZER Sizing Balloon II. AGA Medical received 2 reports from customers who received sizing balloons that were labeled as 34 mm; however, the package contained 24 mm devices. The proper sizing (24 mm) was printed on the device hub visible through the product package.

PRODUCT:
Hospira Power cord use on Symbiq One-Channel infuser and Symbiq Two-Channel infuser. Power cord part number: HSP3306-E07. Used on List No. 16026 - Symbiq One Channel infuser; List No. 16027 - Symbiq Two-Channel infuser. Recall # Z-1596-2011
MANUFACTURER: Hospira Inc., Morgan Hill, CA, letters on November 1, 2010. Firm initiated recall is ongoing.
REASON: Complaints of broken, bent or missing prongs, charring, sparks, visible smoke, burnt smell have been reported on Symbiq AC Power cords.

PRODUCT:
1) Hospira Plum XL Infusion Pump, Single Channel; list number 11555. Recall # Z-1597-2011;
2) Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11846. Recall # Z-1598-2011;
3) Hospira Plum XL Micro/Macro with DataPort Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11859. Recall # Z-1599-2011;  
4) Hospira Plum XL3 Infusion Pump, Triple Channel; list number 11781. Recall # Z-1600-2011;
5) Hospira Plum XL3 Micro/Macro Infusion Pump, Triple Channel, with a 0.1-999 mL/hr flow rate range; list number 11845. Recall # Z-1601-2011;
6) Hospira Plum XL3 Micro/Macro with DataPort Infusion Pump, Triple Channel, with a 0.1-999 mL/hr flow rate range; list number 11855. Recall # Z-1602-2011

MANUFACTURER: Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated February 14, 2011.

Manufacturers: Hospira Inc., Morgan Hill, CA;
Hospira Holdings de, Costa Rica Ltd., Real Cariari, Zona Franca Global, La Aurora de Heredia, Costa Rica. FDA initiated recall is ongoing.

REASON: Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting.

PRODUCT:
MMP 200 Articulating Booms, Catalog Number 0682-000-604SX, Product Number 0682-001-060C. Used for operating room equipment. Recall # Z-1611-2011

MANUFACTURER: Stryker Communications Corp., Flower Mound, TX, by telephone on January 28, 2011 and by letter dated February 11, 2011. Firm initiated recall is complete.

REASON: Utilization of incorrect screws resulted in inadequate thread engagement reducing the load bearing capability of the product.

CLASS III

PRODUCT:
VCare Vaginal-Cervical Ahluwalias Retractor-Elevator devices. The VCare IFU is packaged one per carton of eight VCare Pouched Devices. The Instructions for Use is an 8.5” x 12” 12-page booklet and is packed loose in the carton. Only the carton will have to be opened to replace the old IFU; there is no need to open the sterile packaging of the individual VCare pouches. The ConMed VCARE Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed. VCare Standard Cervical Cup (Catalog# 60-6085-100), VCare Small Cervical Cup (Catalog# 60-6085-101) and VCare Large Cervical Cup (Catalog# 60-6085-102). Recall # Z-1520-2011

MANUFACTURER: ConMed Corp., Utica, NY, by letter on February 2, 2011. Firm initiated recall is ongoing.

REASON: Product manufactured after April 11, 2008, but before August 1, 2009, contains the earlier Instructions For Use, IFU (PN 17416, Rev. D) which does not contain the revisions on the addition of Warning Notes 10 and 11 and the expansion of Warning Note 6 to the VCare Instructions for Use. The reason for the field correction is to provide a copy of the revised IFU to all customers who may have unexpired Vcare devices in their possession that were made prior to August 1, 2009.

PRODUCT:
MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data. Item # 801-905. Recall # Z-1606-2011

MANUFACTURER: Fujirebio Diagnostics, Inc., Malvern, PA, by letter dated July 7, 2010. Firm initiated recall is complete.

REASON: Presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.

PRODUCT:
Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 ¼ inch This kit is comprised of a pouch, wafer, and related accessories (low pressure adaptor, measuring guide, insert and other packaging components); required for application to a patient immediately after ostomy surgery. Product Code # 416921. Recall # Z-1610-2011

MANUFACTURER: Recalling Firm: Convatec Inc., Skillman, NJ, by letter dated February 1, 2011. 

MANUFACTURER: Nypro Dominican Republic, Inc., San Cristobal, Dominican Republic. Firm initiated recall is ongoing.

REASON: Natura Durahesive ConvaTec Moldable Technology Post Operative/Surgical System (57mm) units may contain pouches with 45 mm Natura flanges, therefore the pouch, low pressure adapter and barrier would not fit together.
VOLUME OF PRODUCT IN COMMERCE77 market units

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 02, 2011

CLASS II

PRODUCT: Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as hernia repairs. Recall # Z-1260-2011

MANUFACTURER: Recalling Firm: Ethicon, Inc., Somerville, NJ, letters dated, December 28, 2010, and December 29, 2010.
MANUFACTURER: Ethicon, Inc., Chihuah, Mexico. Firm initiated recall is ongoing.

REASON: The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging.

PRODUCT: 1) Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250. The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patients skin. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker. Recall # Z-1371-2011;2) Medstorm Adult Radiolucent Zoll Medical (Part # 16381. The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patient’s skin. When a patient requires defibrillation, cardio version or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker. Recall # Z-1372-2011

MANUFACTURER: Heart Sync, Inc., Ann Arbor, MI, by letter dated December 23, 2010.
MANUFACTURER: Katecho Inc., Des Moines, IA. FDA initiated recall is ongoing

REASON: The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until immediately prior to using electrodes. and Electrodes may dry out when removed from packaging and exposed to air.

PRODUCT:InfusO.R. Infusion Pump, an Rx syringe infusion pump; product codes 2L3100, 2L3100R, 2L3100U, 2L3100N, 6461500 and 6461500R. These product codes includes refurbished units and InfusO.R. pumps previously sold under the Bard label. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Recall # Z-1378-2011

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated January 11, 2011.  
MANUFACTURER: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.

REASON: Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the InfusOR will not operate. The reason being that the InfusOR (2L3100) Battery Spring has a flat contact that measures .53 inches ?.01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum of .51 inches for the negative terminal diameter.

PRODUCT: The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only. The GMD Universal Sling is a sterile, single use device for the treatment of female stress urinary incontinence. It is comprised of a polypropylene sheath with a disposable universal low density polyethylene sleeve at each end of attachment of the sling to GMD's single use or reusable trocars. The universal sleeve has three trocar insertion points, the distal and proximal trocar insertion points are for inside-out, bottom-up approaches and a sleeve end trocar insertion point is for outside-in, top-down approaches. The design allows the physician to utilize the device for placement of a polypropylene mesh at the urethra or bladder neck. Recall # Z-1390-2011

MANUFACTURER: Recalling Firm: Generic Medical Devices, Gig Harbor, WA, by letter dated February 14, 2011.  
MANUFACTURER: J-PAC, LLC, Somersworth, NH. Firm initiated recall is ongoing.

REASON: Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs..

PRODUCT:
Haemonetics CardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US. Recall # Z-1391-2011

MANUFACTURER: Haemonetics Corp., Braintree, MA, by letter on January 25, 2011. Firm initiated recall is ongoing.

REASON: Update Instructions for Use for the CardioPAT Manual for Leak Detection. User may mis-interpret the air-leak rate displayed by the cardioPAT device when making a determination about chest-drain removal, which could result in the patient experiencing a pneumothorax.

PRODUCT: Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems. Recall # Z-1393-2011

MANUFACTURER: Recalling Firm: Advanced Sterilization Products, Irvine, CA, by letter beginning June 23, 2010.
MANUFACTURER: Amcor Flexibles Healthcare Inc., Mundelein, IL. Firm initiated recall is ongoing.  

REASON: The recall was initiated after Advanced Sterilization Products (ASP) discovered a non-conforming lot. The misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches being used to store sterilized equipment on shelves.

PRODUCT:Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20. Device Part Number (Model Number): 703309. Recall # Z-1394-2011
MANUFACTURER: Recalling Firm: Maquet Cardiovascular US Sales, LLC, Wayne, NJ, letter on October 4, 2010. 
MANUFACTURER: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is complete.
REASON: A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function.

PRODUCT:Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium. Enables a comfortable sitting position and adapts to the patient without the need for individual adjustments when transferring a patient with a lift. Recall # Z-1396-2011

MANUFACTURER: Recalling Firm: Hill-Rom, Inc., Batesville, IN, by letter dated February 9, 2011.
MANUFACTURER: Liko AB, Lulea, Sweden. Firm initiated recall is ongoing.

REASON: Slings were improperly assembled and the loops that are used to support the sling when hung from a lift were too long, potentially putting the patient being lifted at risk of falling out.

PRODUCT: 1) Stryker Navigation System - iNtellect Cranial Software, Part number 6000-650-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1402-2011;2) Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-650-100. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1403-2011;3) Stryker Navigation System - iNtellect Cranial Software, Part number 6000-651-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1404-2011;4) Stryker Navigation System - iNtellect Cranial Software - Upgrade, Part number 6000-651-100. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1405-2011;5) Stryker Navigation System - iNtellect Cranial Software - Maintenance, Part number 6000-651-200. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1406-2011;6) Stryker Navigation System - iNtellect Cranial Navigation Software - Enable, Part number 6000-651-300. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1407-2011;7) Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-652-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1408-2011;8) Stryker Navigation System - iNtellect Cranial Planning Software - Enable, Part number 6000-652-300. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported. Recall # Z-1409-2011;9) Stryker Navigation System - SpineMap 3D Module, Part number 6002-650-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1410-2011;10) Stryker Navigation System - SpineMap 3D - Upgrade, Part number 6002-650-100. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images; measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1411-2011;11) Stryker Navigation System - OrthoMap 3D - Enable, Part number 6002-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images; measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1412-2011;12) Stryker Navigation System - SpineMap 3D - Planning, Part number 6002-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1413-2011;13) Stryker Navigation System - OrthoMap 3D Module, Part number 6005-650-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1414-2011;14) Stryker Navigation System - OrthoMap 3D - Enable, Part number 6005-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images; measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1415-2011;15) Stryker Navigation System - OrthoMap 3D - Planning, Part number 6005-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1416-2011;16) Stryker Navigation System - OrthoMap 3D (Sales Demos), Part number 81-81016. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1417-2011;17) Stryker Navigation System - Spine Map(TM) 3D - Sales Demo SOFTWARE, Part number 81-80045. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1418-2011;18) Stryker Navigation System - SALES DEMO, Part number 81-81016. provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recall # Z-1419-2011;19) Stryker Navigation System - SALES DEMO, Part number 81-81018. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components. Recalling # Z-1420-2011

MANUFACTURER: Recalling Firm: Stryker Instruments Division of Stryker Corp., Kalamazoo, MI, by letters on December 3, 2010.
MANUFACTURER: Stryker Leibinger Gmbh, Freiburg, Germany. Firm initiated recall is ongoing,

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 23, 2011.

CLASS II

PRODUCT:
1) ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; 6TB45; ATG45; ATB45; ATW45; ATS45NK; and NAW45. Intended for transection, resection, and/or creation of anastomoses. Recall # Z-1068-2011;
2) FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric Surgery Trays, XBB14B - Bariatric Surgery Trays, and XBB65S - Bariatric Surgery Trays. Intended for transection, resection, and/or creation of anastomoses. Recall # Z-1069-2011

MANUFACTURER: Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letters dated April 7, 2009.
MANUFACTURER: Ethicon Endo-surgery, Inc. S.a. De C.v., Cd. Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.

REASON: The affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft is insufficient.

PRODUCT:
Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy. Recall # Z-1223-2011

MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated October 2005 and November 22, 2005.
MANUFACTURER: Elekta Instrument AB, Stockholm, Sweden. Firm initiated recall is complete.

REASON: If a user accidentally selects the wrong image/tube position images can be displayed flipped.

PRODUCT
1) Thomas Medical Products, Y-Glide (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass) for use during vascular interventional procedures. Part No. FTB-021-00, Catalog No. FTB-021-00. Recall # Z-1225-2011;
2) Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis Valve) for use during vascular interventional procedures. Part No. FCL-051-00, Catalog No. HLS2507MCN; and Part No. FCL-051-02, Catalog No. HLS2507MCN. Recall # Z-1226-2011;
3) Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular interventional procedures. SafeSheath Sealing Adapter, Part No. FCL-094-03, Catalog No. SSSA-EW-09; SafeSheath Sealing Adapter, Part No. FCL-141-01, Catalog No. 369826; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07; Transvalvular Insertion Tool (TVI), Part #MIS-122-00, Catalog No. TVI-09; and CPS SafeSheath Sealing Adapter, Part No. XD-2754-00, Catalog No. 410195. Recall # Z-1227-2011;
4) Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve, Acuity Universal Cutter, and Contamination Sleeve for use during vascular interventional procedures. a) Contamination Sleeve part no. CON-006-02; b) Acuity Bleedback Control Valve part no. CSP-001-00; c) Acuity Rotating Hemostasis Valve part no. CSP-002-01; d) Acuity Universal Cutter part no. CSP-003-00; e) Acuity Universal Cutter part no. CSP-003-01. Recall # Z-1228-2011

MANUFACTURER: Thomas Medical Products Inc., Malvern, PA, by letter dated December 16, 2010. Firm initiated recall is ongoing.

REASON: Compromised sterility/weak or open seals.

PRODUCT:
AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; The GreenLight Surgical Laser System and accessories are intended for use in endoscopic (cystscopic) KTP 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia (BPH). The entire laser unit and controls are contained in a single console that is connected to external electricity and water sources. Fibers are sterile, single-use, disposable fiber optic delivery systems, designed to deliver 532nm laser energy, the fiber is connected to the laser console and used to cut, coagulate and vaporize prostate tissue.. Recall # Z-1229-2011

MANUFACTURER: AMS Innovative Center - San Jose, San Jose, CA, by letters via express mail on February 8, 2010, and September 15, 2010. Firm initiated recall is ongoing.

REASON: A failure mode whereby the fiber attachment to the GreenLight PV laser system could inadvertently be broken. If fiber were to bend sharply at point of fiber connection, it may break and cause a burn.

PRODUCT:
Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1. The Terumo Bipolar cord MCBICORD1 is a flexible, reusable power cable that is indicated for use with the Terumo VirtuoSaph Endoscopic Vein Harvesting System and a compatible generator during saphenous vein harvesting procedures. Z-1230-2011

MANUFACTURER: Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter dated January 10, 2011. Firm initiated recall is ongoing.

REASON: The Bipolar cord product specification indicates the product has a service life of 50 uses. However the IFU does not specify an end of service life. The firm has received 46 complaints on the Bipolar cord. The firm investigated and found that the units involved in the complaints were often over 12 months old. The firm believes the units involved in the complaints were beyond their product life specification.

PRODUCT:
Integra Peritoneal Introducer Sheaths, 61 cm; Integra NeuroSciences/REF 901-124; Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus. Recall # Z-1231-2011

MANUFACTURER: Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated December 22, 2010.
MANUFACTURER: Integra Neurosciences Implants S.A., Sophia Antipolis, France. Firm initiated recall is ongoing.

REASON: Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.

PRODUCT:
1) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190021775. Recall # Z-1232-201
2) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190021991. Recall # Z-1233-2011;  
3) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190070031. Recall # Z-1234-2011;
4) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190020775. Recall # Z-1235-2011;
5) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190020991. Recall # Z-1236-2011;
6) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190020105. Recall # Z-1237-2011;
7)  Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries; Part Number 5190020060. Recall # Z-1238-2011;
8) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries. Part Number 519002012. Recall # Z-1239-2011;
9) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries. Part Number 5190020047. Recall # Z-1240-2011;   
10) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries. Part Number 5190013160. Recall # Z-1241-2011;
11) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries. Part Number 5190013150. Z-1242-2011;
12) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries. Part Number 5190013140. Recall # Z-1243-201;
13) Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries. Part Number 5190013170. Recall # Z-1244-2011

MANUFACTURER: Recalling Firm: Stryker Instruments Division of Stryker Corp., Kalamazoo, MI, by letter dated December 2, 2010. 
MANUFACTURER: Stryker Ireland, Ltd., Orthopedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is complete.  

REASON: Product was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.

PRODUCT:
GE Centricity Laboratory software; The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. The Centricity Laboratory software is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and report processing. The centricity is intended to interface with various lab devices through standard HL7 interfaces to record, report and distribute lab results. Recall # Z-1245-2011

MANUFACTURER: Recalling Firm: GE Healthcare IT, Barrington, IL, by letters dated December 12, 2010.  MANUFACTURER: Triple G Systems Group, Inc., Markham Ontario, Canada. Firm initiated recall is ongoing.

REASON: The GE Centricity Laboratory System Software has safety issues with the "Telephone List" function, the "Anatomic Pathology" application, and the Instrument Interface IO module that may impact patient safety.

PRODUCT:
ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each); ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-328, NF DB UL 6 Convertible .018-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-418, NF DB UL/LR 6&7 Mini Single .022 0T 0O; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-427, NF DB UR 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Label ID Reference Number 351-428, NF DB UL 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-459, NF DB LR 6 Convertible .022-25T 4DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-460, NF DB LL 6 Convertible .022-25T 4DO HK-Each. Recall # Z-1246-2011

MANUFACTURER: Recalling Firm: Ortho Organizers Inc., Carlsbad, CA, by letter, dated November 1, 2010.
MANUFACTURER: Ortho Solutions Lc Dyna Flex, Saint Ann, MO. Firm initiated recall is ongoing.

REASON: Products were mis-labeled as nickel free.

PRODUCT:Mantis Tap Sleeve, packaged in the following products: Specialty Mantis Modular Tap Set - Catalog #IS2162MAN; Custom Tap Sleeve - Catalog #IS830MAN; Custom Tap Sleeve, Mantis - Catalog #IS2271MAN; and Custom Mantis Modular Tap Set - Catalog #IS2080MAN The Mantis Tap Sleeves with Markers was designed to be used in a manner identical to the predicate Standard Mantis Tap Sleeve 48281315. It is to be used in conjunction with Standard Mantis Cannulated Modular Taps: 1) to protect soft tissue from the cutting edge of the tap 2) to indicate the depth at which the Tap has been inserted. Recall # Z-1247-2011

MANUFACTURER: Recalling Firm: Stryker Spine, Allendale, NJ, letter dated January 07, 2011. 
MANUFACTURER: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.

REASON: Stryker Spine has received reports that after sterilization but prior to surgery, cracks were noticed at the tantalum marker / PEI tube interface. This can likely be attributed to differences in the rate of thermal expansion between the markers and the sleeve during the sterilization cycle.

PRODUCT:
Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA. Recall # Z-1248-2011

MANUFACTURER: Gendex Dental Systems, Des Plaines, IL, by letter dated December 17, 2010. Firm initiated recall is completed.

REASON: The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient

PRODUCT:
Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H29, HCX. Recall # Z-1249-2011

MANUFACTURER: Varian Medical Systems Oncology Systems, Palo Alto, CA, by letters on June 23, 2010. Firm initiated recall is ongoing.

REASON: Position errors may result in misdelivery of radiation.

PRODUCT:
Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0 The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration. 3X The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing , archiving, printing, reporting and networking of NM data including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomnographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gammna cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans and with physiological signals, in order to: depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. Recall # Z-1250-2011

MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated January 12, 2011.
MANUFACTURER: GE Medical System Israel LTD, Tirat Hacarmel, Israel. Firm initiated recall is ongoing.

REASON: Healthcare has become aware of safety issues relevant for the Xeleris Workstation 1.0, 1.1, 2.0, 2.1, 3.0: 1. Measurements taken on the CT Images on the CT system are different from the Xeleris Workstation 2. Inaccurate PET SUV values may be calculated when data is retrieved from PACS after being processed in the Xeleris. 3. Wrong marking of Early and Late result series on display in Brain SPECT when 2 result series are opened in compare mode. These issues may impact patient safety

PRODUCT
Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data. Recall # Z-1251-2011

MANUFACTURER: alling Firm: Elekta, Inc., Norcross, GA, by letter dated June 22, 2009.   
MANUFACTURER: Elekta Instrument AB, Stockholm, Sweden. FDA initiated recall is complete.
REASON: protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts.

PRODUCT:
Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Recall # Z-1252-2011

MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, GA, by letters dated January 5, 2011.
MANUFACTURER: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, United Kingdom. Firm initiated recall is ongoing.

REASON: Flexmap calibration did not cover the full 360 degrees of gantry rotation (0 to 355 degrees) and that this caused an isocenter displacement with 2D PlanarView images required at 180 to -180.

PRODUCT:
1) 1) Flexicair? II (Model number 13000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where xxxxxx is a six digit number. The prefix IB is representative of a Flexicair II, prefix IC is representative of a Flexicair MC3 and a six digit number without a prefix is representative of a refurbished Flexicair MC 3. Z-1253-2011;
2) Flexicair? MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where xxxxxx is a six digit number. The prefix IB is representative of a Flexicair II, prefix IC is representative of a Flexicair MC3 and a six digit number without a prefix is representative of a refurbished Flexicair MC 3. Recall # Z-1254-2011

MANUFACTURER: Hill-Rom Manufacturing, Inc., Charleston, SC, by letter dated December 15, 2010. Firm initiated recall is ongoing.

REASON: Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.

PRODUCT:
1) Face Tent Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Hospilak Ref. No. 111-E, Face Tent, Adult No Tubing, with 15mm OD Connector Hospilak Ref. No. 115-E, Face Tent, Adult 5 (1.5m) Tubing Hospilak Ref. No. 116-E, Face Tent, Adult 6 (1.8 m) Aerosol Tubing McKesson Aerosol Mask, Face Tent Adult, No Tubing Reorder No. 86-110E Face Tent Adult, 6 (1.8m) Aerosol Tubing Reorder no. 86-116E Smiths Medical Portex First Breath Adult Face Tent (Non-latex) Ref 001490 Smiths Medical Portex First Breath Adult Face Tent with Tubing, 188cm (5 ft.) (Non-latex) Ref 001492 Owens & Minor MediChoice Adult Face Tent Re-Order #RSP3000 and Face Tent, Adult 6 (1.8m) Aerosol Tubing Re-Order #RSP3060. Recall # Z-1255-2011;
2) Oxygen Masks- Labeling as follows: MADA, Inc. Adult Medium Concentration Oxygen Mask with Non-crush 7 Coiled Tubing, Connector Both Ends No 1327; RESPIREX Aerosol Mask Adult Elongated RESPIREX Nebulizer Kits w/Aerosol Mask Adult 7 ft. (2.1m) Aerosol Tubing, Hospilak REF 100-E Aerosol Mask Adult Unomedical, Inc., Hospilak Ref. No. 101-E, Adult Aerosol Mask w/Aerosol Connector, 15 mm; Hospilak Ref. No. 102-E, Medium Concentration Mask, Adult 7 (2.1m) Tubing Unomedical, Inc., Hospilak Ref. No. 103-E, Medium Concentration Mask, Adult Unomedical, Inc., Hospilak REF 104-E High Concentration Rebreather Oxygen Mask, Adult w/7 (2.1)m) Oxygen Tubing, Unomedical, Inc., Hospilak Ref. No. 105-E, High Concentration Rebreather Oxygen Mask, Adult, No Tubing Unomedical, Inc., Hospilak Ref. No. 106-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak Ref. No. 108-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak Ref. No. 118-E, Aerosol Mask Elongated, Adult 6 (1.8 m) Aerosol Tubing Unomedical, Inc., Hospilak Ref. No. 120-E, Venturi Mask Kit, Adult All Diluters No-Crush MADA INC. Aerosol Mask, Adult Size, Elongated MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient Use MADA INC. Aerosol Mask, Pediatric Size, Elongated No 1327 100% Latex Free MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient Use MADA INC. Up- Mist Medication Nebulizer With 7 ft. Oxygen Tubing and Elongated Aerosol Mask No. 1310MA 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient Use MADA INC Up-Mist Medication Nebulizer with 7 ft. Oxygen Tubing and Pediatric Aerosol Mask No. 1310 NMP 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient Use Unomedical, Inc., Hospilak REF No. 131-E, Venturi Mask Kit, Adult with 31% diluter only, MADA, Inc. Child/Pediatric Medium Concentration Oxygen Mask with Non-Crush 7 Coiled Tubing, Connector Both Ends, NO 1327C, Unomedical, Inc., Hospilak REF No. 182-E, 3-in-1 Emergency Mask, Elongated Adult, 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 200-E, Aerosol Mask, Adult Small, No Tubing, Unomedical, Inc., Hospilak REF No. 202-E, Medium Concentration Oxygen Mask, Adult with 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 220-E, Aerosol Mask, Pediatric, No Tubing, Unomedical, Inc., Hospilak REF No, 221-E, Aerosol Mask Elongated, Pediatric 5 (1.5m) Aerosol Tubing Unomedical, Inc., Hospilak REF No. 222-E, Medium Concentration Oxygen Mask, Pediatric with 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 223-E, Medium Concentration Oxygen Mask, Pediatric No Tubing, Unomedical, Inc., Hospilak REF No. 228-E, Up-Mist Nebulizer with 7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask Elongated Unomedical, Inc., Hospilak REF No. 245-E, Adult Trach Mask Unomedical, Inc., Hospilak REF No. 246-E, Pediatric Trach Mask Unomedical, Inc., Hospilak REF No. 260-E, Aerosol Mask, Infant No Tubing, Unomedical, Inc., Hospilak REF No. 263-E, Medium Concentration Mask Infant, No Tubing, Unomedical, Inc., Hospilak REF No. 282-E, 3 in 1 Emergency Mask, Elongated Pediatric, 7 (2.1m) Oxygen Tubing TRI-ANIM Adult Aerosol Mask Elongated adult aerosol mask with elastic strap and adjustable noseclip Part Number 301-170 50/case eValueMed Tri-anim Pediatric Aerosol Mask Elongated pediatric aerosol mask with elastic strap and adjustable noseclip Part Number 301-171 50/case eValueMed Tri-anim Adult Oxygen Mask Elongated adult medium mask with elastic strap and adjustable noseclip Part Number 301-180 eValueMed Tri-anim Adult Oxygen Mask Elongated adult non-rebreathing oxygen mask with check valve, two side valves, 7 smooth bare tubing Part Number 301-182 eValueMed Unomedical, Inc., Hospilak REF No. 3102-E, Medium Concentration Mask, Adult 7 (2.1m) Tubing Unomedical, Inc., Hospilak REF No. 3106-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak REF No. 3108-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak REF No. 3120-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak REF No. 3182-E 3-in-1 Emergency Mask Elongated Adult, 7 (2.1m) Oxygen Tubing with Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3222-E Medium Concentration Oxygen Mask Pediatrict with 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak REF No. 3224-High Concentration Rebreather Oxygen Mask, Pediatric w/7 (2.1m) Oxygen Tubing and Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3224-High Concentration Rebreather Oxygen Mask, Pediatric w/7 (2.1m) Oxygen Tubing and Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3225-E High Concentration Non-Rebreather Oxygen Mask, Pediatric w/7 (2.1m) Oxygen Tubing and Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3227-E Venturi Mask Kit, Pediatric, All Diluters, Oxygen Tubing with FitsAll Oxygen Connector Unomedical, Inc., Hospilak REF No. 3230-E High Concentration, Non-Rebreather Oxygen Mask, Pediatric with 7 (2.1m) Oxygen tubing Fits-all Oxygen Connector Unomedical, Inc., Hospilak REF No. 3247-E Venturi Trach Mask Kit, Adult All Diluters Unomedical, Inc., Hospilak REF No. 3262-E Oxygen Mask Infant, Medium Concentration w/ 7 (2.1m) Oxygen Tubing, Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3264-E High Concentration Rebreather Oxygen Mask, Infant w/7 (2.1m) Oxygen Tubing and Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3266-E High Concentration Non- Rebreather Oxygen Mask, Infant w/7 (2.1m) Oxygen Tubing and Fits-All Oxygen Connector Unomedical, Inc., Hospilak REF No. 3776-E OPTI-MIST CLEAR Nebulizer w/7 (2.1m) Oxygen Tubing, Adult Aerosol Mask, Elongated Unomedical, Inc., Hospilak REF No. 3777-E OPTI-MIST CLEAR Nebulizer w/7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask, Elongated Unomedical, Inc., Hospilak REF No. 753-E OPTI-MIST Nebulizer kit, w/7 (2.1m) Oxygen Tubing, and Adult Mask Unomedical, Inc., Hospilak REF No. 776-E OPTI-MIST Clear Nebulizer kit, w/7 (2.1m) Oxygen Tubing, Adult Aerosol Mask, Elongated Unomedical, Inc., Hospilak REF No. 777-E OPTI-MIST Clear Nebulizer kit, w/7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask, Elongated Unomedical, Inc., Ref. No. 953-E UP-MIST Nebulizer Kit, with 7 (2.1m) Oxygen Tubing, Aerosol Mask, Adult The following are under McKesson brand: McKesson Aerosol Mask, Elongated Adult No Tubing, Reorder No. 86-100E. Oxygen Mask, Elongated Adult Medium Concentration, 7 (2.1m) Oxygen Tubing Reorder No. 86-102E Oxygen Mask, Elongated Adult High Conc. Non-Rebreather, 7 (2.1m) Oxygen Tubing, Check Valve, One Side Valve Reorder no. 86-106 E. Oxygen Mask, Elongated Adult High COnc. Non-Rebreather, 7 (2.1m) Oxygen Tubing, Check Valve, Two Side Valves Re-order No. 86-108E 3-1 Emergency Masks, Elongated Adult, 7 (2.1m) Oxygen Tubing Reorder no. 86-182 E Oxygen Mask, Adult Medium Concentration, 7 (2.1m) Oxygen Tubing Reorder no. 86-202E Aerosol Mask, Elongated Pediatric No Tubing Reorder No. 86-220E Oxygen Mask, Elongated Pediatric Medium Concentration, No Tubing Reorder No. 86-223E Up-mist Nebulizer Kit, with 7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask Elongated Reprder No. 86-228E Trach Mask Adult, No Tubing Reorder No. 86-245E Oxygen Mask, Elongated Pediatric, High Conc. Non-Rebreather, 7 (2.1m) Oxygen Tubing, w/FITS-ALL Oxygen Connector Reorder no. 86-3226E OPTI-MIST Clear Nebulizer Kit w/7 (2.1m) Oxygen Tubing, Adult Aerosol Mask, Elongated Reorder No. 86-776E OPTI-MIST CLEAR Nebulizer, Kit w/ 7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask, Elongated Reorder No. 86-777E ******** Smiths Medical Portex First Breath Adult Oxygen Mask with Tubing, 213 cm (7 ft) Ref 001421 Smiths Medical Portex First Breath 3 in 1 Oxygen Mask with Reservoir Bag (1L) and Tubing, 213 cm (7 ft) (Non-latex) Ref 001423 Smiths Medical Portex First Breath Adult Aerosol Mask (Non-Latex) Ref 001426 Smiths Medical Portex First Breath Adult Elongated Non-Rebreather Oxygen Mask with 1L Reservoir Bag and Tubing, 213 cm (7 ft.) Ref 001431 Smiths Medical Portex First Breath Pediatric Medium Concentration Oxygen Mask with Tubing , 213 cm (7ft) (Non-Latex) Ref 001431 Smiths Medical Portex First Breath Pediatric Aerosol Mask (Non-latex) Ref 001476 Smiths Medical Portex First Breath Adult Venturi Oxygen Mask with corrugated tubing, 02 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-Latex) Ref 002610 Smiths Medical Portex First Breath Adult Venturi Oxygen Mask with corrugated tubing, 02 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-Latex) Ref 002620 The following are under Metro brand: Metropolitan Medical, Inc Metro Disposable Latex Free Medium Concentration Oxygen Mask 7 ft. Universal Oxygen Tubing Reorder number 7102 360-4. Pediatric Medium Concentration Oxygen Mask & 7 ft. Universal Oxygen Tubing Reorder Number 7222 Pediatric Non-Rebreather Oxygen Mask & 7 ft. Universal Oxygen Tubing Reorder number 7226 ******* Owens & Minor MediChoice Opti-mist Clear Nebulizer w/7 (2.1m) Oxygen Tubing, Adult Aerosol Mask, Elongated Re-Order #RSP0470 The following are under MediChoice Brand MediChoice Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing RE-Order #RSP111 , #RSP1112, MediChoice High Concentration Rebreather Oxygen Mask, Adult w/7 (2.1m) Oxygen Tubing Re-order #RSP1120 MediChoice Medium Concentration Mask, Adult 7 (2.1m) tubing Re-order #RSP1200, RSP 1200A MediChoice Medium Concentration Oxygen Mask, Pediatric with 7 (2.1m) Oxygen Tubing Re-order #RSP1200P MediChoice Adult Trach Mask Re-Order #RSP2000 MediChoice Venturi Mask Kit, Adult All Diluters No-Crush Lumen Oxygen Tubing Re-Order # RSP4005 MediChoice Adult Aerosol Mask Re-Order #RSP5000 MediChoice Aerosol Mask, Pediatric Re-Order #RSP5000P. Recall # Z-1256-2011

MANUFACTURER: Recalling Firm: Convatec Inc., Skillman, NJ, by letters dated January 7, 2011. 
MANUFACTURER: Unomedical S.A. de C.V. Reynosa, Tam, Mexico. Firm initiated recall is ongoing

REASON: Face tents and Oxygen masks may have a sticky glue-like substance on the inside or outside of the mask consisting of dioctyl phthalate, epoxidized soybean oil and glycerol monoleate.

PRODUCT:
Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner. Recall # Z-1257-2011

MANUFACTURER: Recalling Firm: Toshiba American Medical Systems Inc., Tustin, by letter on September 7, 2010.
MANUFACTURER: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.  

REASON: Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV. This results in a pre-scan expected dose that is approximately 10% lower than what the displayed value should be when the scanner executes the exam Plan.

PRODUCT
Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Calibrator, Accessory Box, Instruction Manual and Quick Guide Intended use: Measurement of Hemoglobin A1c in human whole blood. Catalog No. 270-2716. Recall # Z-1259-2011

MANUFACTURER: Bio-Rad Laboratories Inc., Hercules, CA, by letters dated February 5, 2010, and February 16, 2010. Firm initiated recall is ongoing.

REASON: The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantization of the blood results.

PRODUCT:
1) Product Number: 02.122.550, 50mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1261-2011;
2) Product Number: 02.122.550S, 50mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1262-2011;
3) Part Number: 02.122.551, 50mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1263-2011;
4) Part Number: 02.122.551S, 50mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1264-2011;
5) Part Number: 02.122.555, 55mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1265-2011;
6) Part Number: 02.122.555S, 55mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1266-2011;
7) Part Number: 02.122.556, 55mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1267-2011;
8) Part Number: 02.122.556S, 55mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1268-2011;
9) Part Number: 02.122.561, 60mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1269-2011;
10) Part Number: 02.122.561S, 60mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1270-2011;
11) Part Number: 02.122.565, 65mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1271-2011;
12) Part Number: 02.122.565S, 65mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1272-2011;
13) Part Number: 02.122.566, 65mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1273-2011;
14) Part Number: 02.122.566S, 65mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SysteFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1274-2011;
15) Part Number: 02.122.570, 70mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1275-2011;
16) Part Number: 02.122.570S, 70mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1276-2011;
17) Part Number: 02.122.571, 70mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1277-2011;
18) Part Number: 02.122.571S, 70mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1278-2011;
19) Part Number: 02.122.575, 75mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall  # Z-1279-2011;
20) Part Number: 02.122.575S, 75mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1280-2011;
21) Part Number: 02.122.576, 75mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1281-2011;
22) Part Number: 02.122.576S, 75mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade PlatFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.e System. Recall # Z-1282-2011;
23) Part Number: 02.122.580, 80mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1283-2011;
24) Part Number: 02.122.580S, 80mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1284-2011;
25) Part Number: 02.122.581, 80mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1285-2011;
26) Part Number: 02.122.581S, 80mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1286-2011;
27) Part Number: 02.122.585, 85mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1287-2011;
28) Part Number: 02.122.585S, 85mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1288-2011;
29) Part Number: 02.122.586, 85mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1289-2011;
30) Part Number: 02.122.586S, 85mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1290-2011;
31) Part Number: 02.122.590, 90mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1291-2011;
32) Part Number: 02.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1292-2011;
33) Part Number: 02.122.591, 90mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1293-2011;
34) Part Number: 02.122.591S, 90mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1294-2011;
35) Part Number: 02.122.595, 95mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1295-2011;
36) Part Number: 02.122.595S, 95mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1296-2011;
37) Part Number: 02.122.596, 95mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1297-2011;
38) Part Number: 02.122.596S, 95mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1298-2011;
39) Part Number: 02.122.600, 100mm Spiral Blade, 14mm, Right- Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1299-2011;
40) Part Number: 02.122.600S, 100mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-300-2011;
41) Part Number: 02.122.601, 100mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1301-2011;
42) Part Number: 02.122.601S, 100mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1302-2011;
43) Part Number: 02.122.605, 105mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1303-2011;
44) Part Number: 02.122.605S, 105mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1304-2011;
45) Part Number: 02.122.606, 105mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1305-2011;
46) Part Number: 02.122.606S, 105mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1306-2011;
47) Part Number: 02.122.610, 110mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1307-2011;
48) Part Number: 02.122.610s, 110mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1308-2011;
49) Part Number: 02.122.611, 110mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1309-2011;
50) Part Number: 02.122.611S, 110mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1310-2011;
51) Part Number: 02.122.615, 115mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1311-2011;
52) Part Number: 02.122.615S, 115mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1312-2011;
53) Part Number: 02.122.616, 115mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1313-2011;
54) Part Number: 02.122.616S, 115mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1314-2011;
55) Part Number: 02.122.620, 120mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1315-2011;
56) Part Number: 02.122.620S, 120mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1316-2011;
57) Part Number: 02.122.621, 120mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1317-2011;
58) 120mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade, Part Number: 02.122.621S, Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Recall # Z-1318-2011

MANUFACTURER: Recalling Firm: Synthes USA (HQ), Inc., West Chester, PA, by letter dated October 20, 2010.
MANUFACTURER: Synthes (USA), Horseheads, NY. Firm initiated recall is ongoing.

REASON: Potential for out of specification star grind teeth.

PRODUCT:
1) WalkMed Infusion Triton 90” 20 drop IV Administration Set with 2 Needlefree Y-sites and Back Check Valve; Item # T090-000W; Intended use: Intravascular Administration Set. Recall # Z-1319-2011;
2) WalkMed Infusion Triton 90” 20 drop IV Administration Set with 2 Needlefree Y-site; Item # T090-000V, Intended use: Intravascular Administration Set. Recall # Z-1320-2011;
3) WalkMed Infusion Triton 90” 20 drop IV Administration Set with 2 Needlefree Y-site and 0.22, Intended use: Intravascular Administration Set. Recall # Z-1321-2011;
4) “20 drop IV Administration Set; Item # T090-000, Intended use: Intravascular Administration Set. Recall # Z-1322-2011;
5) Churchill Medical Systems Central Line Dressing Kit; Item # AMS-8316CP-1, Intended use: Intravascular Administration Set. Recall # Z-1323-2011;
6) WalkMed Infusion 100” 20 drop IV Administration Set with 1 Needlefree Y-site and Free Flow Protection Clip, Item # T100-000F, Intended use: Intravascular Administration Set. Recall # Z-1324-2011;
7) Churchill Medical 78” Stopcock Extension Set with male/female red cap; item # AMS-464-1 Intended use: Intravascular Administration Set. Recall # Z-1325-2011;
8) Churchill Medical Systems 6” Microbore Trifurcated non-DEHP Extension Set with male/Female Luer Locks Slide Clamps & 0.2 Micron Filter Item Number: AMS-944, Intended use: Intravascular Administration Set. Recall # Z-1326-2011;
9) Churchill Medical Systems LifeGuard Non-Coring Huber Needle, Lifeguard Non-Coring Safety Infusion Set 22GA, 3/4"; Item # CLG-2234 The Lifeguard. Recall # Z-1327-2011;
10) WalkMed Infusion Triton 100" 20 Drop IV Administration Set with Free Flow Protection Clip; Item # T100-000F Intended use: Intravascular Administration Set. Recall # Z-1328-2011;
11) Churchill Medical Systems Fluid Transfer Set; Sterile Item # AMS-451; Intended use: Intravascular Administration Set. Recall # Z-1329-2011;
12) Churchill Medical Systems 14"Extension Set with SmartSite Injection, Item # 43000E; Intended use: Intravascular Administration Set. Recall # Z-1330-2011;
13) Churchill Medical Systems Central Line and Port Dressing Kit; Item AMS-8295CP-1; Intended use: Intravascular Administration Set. Recall # Z-1331-2011;
14) FMI 105"Oral Surgery Administration Set; Item AMS-468-1; Intended use: Intravascular Administration Set. Recall # Z-1332-2011;
15) Winged Infusion Set with 90 degree Huber Needle and Y Injection Site, Item # FIY-2210; Intended use: Intravascular Administration Set. Recall # Z-1333-2011

MANUFACTURER: Churchill Medical Systems, Inc., Dover, NH, by letter dated November 16, 2010. Firm initiated recall is ongoing.

REASON: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.

PRODUCT:
1) Oasis Corneal Marking Pad, REF 0441, Rx only, Sterile. For use in ophthalmic surgery. Recall # Z-1335-2011;
2) Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic surgery. Recall # Z-1336-2011;
3) Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery. Recall # Z-1337-2011;
4) CYNACON OCuSOFT LASIK Marker Pads, REF 750-093, Rx Only, Sterile. For use in ophthalmic surgery. Recall # Z-1338-2011;
5) Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery. Recall # Z-1339-2011;
6) Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For use in ophthalmic surgery. Recall # Z-1340-2011

MANUFACTURER: Aspen Surgical Products, Inc., Caledonia, MI, by letters dated December 23, 2010. Firm initiated recall is ongoing.

REASON: Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.

PRODUCT:
Celite ACT Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery organ transplantation and dialysis. 510 K number K992571. Recall # Z-1341-2011

MANUFACTURER: Abbott Point Of Care Inc., Princeton, NJ, by letter dated November 2010, and December 3, 2010. Firm initiated recall is ongoing

REASON: Celite ACT cartridges have increased numbers of values outside the accepted allowable.

PRODUCT:
1) SINGLE SHOT EPIDURAL ANESTHESIA KIT/Product SKU's (Codes): a) AK-03000, b) AM-03000, c) BH-03000, d) DH-03000, e) KC-03000, f) SA-03001 and g) SH-03001. Epidural Anesthesia Kit. Recall # Z-1343-2011;
2) INTERNAL JUGULAR PUNCTURE KIT with Blue FlexTip(R) Catheter/Product SKU (Code) AK-04050 Internal jugular puncture kit. Recall # Z-1344-2011;
3) PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E Pediatric jugular puncture kit. Recall # Z-1345-2011;
4) ARTERIAL LINE KIT/Product SKU (Code) AK-04510 Arterial line kit. Recall # Z-1346-2011;
5) VESSEL CATHETERIZATION KIT/Product SKU's (Codes): a) AK-04550, b) AK-4550-A and c) ASK-04550-TG. Vessel catheterization kit. Recall # Z-1347-2011;
6) CENTRAL VENOUS CATHETERIZATION KIT/Product SKU's (Codes): a) AK-04650-E and b) AK-04660. Central venous catheterization kit. Recall # Z-1348-2011;
7) JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04800. Jugular puncture kit. Recall # Z-1349-2011;
8) EPIDURAL CATHETERIZATION KIT with FlexTip Plus(R) EPIDURAL CATHETER -- Product SKU (Code) AP-08100. Epidural catheterization kit. Recall # Z-1350-2011;
9) ACCESS TRAY/Product SKU's (Codes): a) ASK-03000-CHUQ, b) ASK-03000-CHUQ1, c) ASK-04001-GFH, d) ASK-04001-SUH and e) ASK-04001-UHC. Access tray for epidural anesthesia kit. Recall # Z-1351-2011;
10) EPIDURAL ANESTHESIA KIT/Product SKU's (Codes): a) ASK-03001-KC, b) ASK-03001-KC1 and c) HH-03000. Epidural anesthesia kit. Recall # Z-1352-2011;
11) PREP TRAY/Product SKU (Code) ASK-04001-SLE. Prep tray for epidural anesthesia kit. Recall # Z-1353-2011;
12) NERVE BLOCK PREP TRAY/Product SKU (Code) ASK-04001-VCU. Nerve block prep tray for epidural anesthesia kit. Recall # Z-1354-2011;
13) ARTERIAL CATHETERIZATION KIT/Product SKU (Code) ASK-04100-AMC. Arterial catheterization kit. Recall # Z-1355-2011;
14) RADIAL ARTERY CATHETERIZATION KIT/Product SKU (Code) ASK-04120-VBH. Cardiovascular artery catheterization kit. Recall # Z-1356-2011;
15) QuickFlash(R) RADIAL ARTERY/ARTERIAL LINE CATHETERIZATION KIT/Product SKU (Code) ASK-04500-HF. Radial artery catheterization kit. Recall # Z-1357-2011;
16) ARTERIAL CATHETERIZATION KIT/Product SKU's (Codes): a) CC-04100, b) FS-04510, c) NS-04100 and d) PW-04100. Cardiovascular catheterization kit. Recall # Z-1358-2011;  
17) RADIAL ARTERY CATHETERIZATION KIT with SHARPS SAFETY FEATURES/Product SKU (Code) HF-04020-1. Cardiovascular catheter wire guide. Recall # Z-1359-2011;
18) ARTERIAL ACCESS TRAY/Product SKU (Code) MMC-04001-1. Arterial access tray for radial artery catheterization set. Recall # Z-1360-2011;
19) EPIDURAL CATHETERIZATION KIT with FlexTip Plus(R) CATHETER/Product SKU (Code) NH-05501. Anesthesia conduction kit. Recall # Z-1361-2011

MANUFACTURER: Recalling Firm: Arrow International Inc., Reading, PA, by letter dated October 29, 2010.
MANUFACTURER: Arrow International Inc., Asheboro, NC. Firm initiated recall is ongoing. Firm initiated recall is ongoing.

REASON: Sterility may be compromised.

PRODUCT:
1) ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. Recall # Z-1362-2011;
2) ConMed System 2450 Electrosurgical Generator, REF 60-2450-120, 120 V. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. Recall # Z-1363-2011;
3) ConMed System 2450 Electrosurgical Generator, REF 60-2450-220, 220 V. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. Recall # Z-1364-2011;
4) ConMed System 2450 Electrosurgical Generator, REF 60-2450-230, 230V-240V. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. Recall # Z-1365-2011;
5) ConMed System 2450 Electrosurgical Generator, REF 60-2450-120-69, 120V, (Refurbished). A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. Recall # Z-1366-2011

REASON: Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.

PRODUCT:
MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): a) A0030/1; b) A0031/1; c) A0032/1; d) A0033/1, Cardio Life Research S.A., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery. Recall # Z-1370-2011

MANUFACTURER: St. Jude Medical Cardiovascular Division, Minnetonka, MN, by letter dated January 26, 2011. Firm initiated recall is ongoing.

REASON: St. Jude Medical Cardiovascular Division is conducting a voluntary recall of all batches and model numbers of the MitraXs Self Adjusting Atrial Retractor. St. Jude Medical has been distributing this product since their acquisition of CLR in late 2008. They have determined that some distributed batches have very small burrs on the polycarbonate material at the distal edge. As these burrs may be undetectable prior to use, there is a potential for them to detach during product use, enter the systemic circulation , and possibly lead to distal vessel micro-embolization. To date, there have been no reports of this event occurring and no adverse event related to this issue have been reported to St. Jude Medical.

CLASS III

PRODUCT:
Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423. Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). Recall # Z-1342-2011

MANUFACTURER: Bio-Rad Laboratories Inc., Hercules, CA, by letter dated March 24, 2010. Firm initiated recall is ongoing.

REASON: The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated.

 
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 16, 2011.

CLASS I

PRODUCT
1) Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips. Recall # Z-0994-2011;
2) Abbott Diabetes Care Optium EZ Blood Glucose Test Strips. Recall # Z-0995-2011;
3) Abbott Diabetes Care, a) MediSense Optium Blood Glucose Test Strips; b) MediSense Optium Blood Glucose Electrodes. Recall # Z-0996-2011;
4) Abbott Diabetes Care, Optium Blood Glucose Test Strips. Recall # Z-0997-2011;
5) Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips. Recall # Z-0998-2011;
6) Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips; Precision Xtra Blood Glucose & Ketone Monitoring System; Precision G3b Smartblue Blood Glucose Test Strips. Recall # Z-0999-2011;
7) Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test. Recall # Z-1000-2011
MANUFACTURER: Abbott Diabetes Care, Inc., Alameda, CA, by press release and letters on December 22, 2010. Firm initiated recall is ongoing.
REASON: Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results.

PRODUCT :
1) Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: " Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain Preservative-free sterile saline, USP, can be used to achieve the physician prescribed concentration of preservative-free morphine sulfate sterile solution. " Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain Preservative-free sterile saline, USP, can only be used to achieve the physician prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. "Chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen injection)." Chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency. Z-1060-2011;
2) Medtronic Synchromed implantable drug pump Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, 8566 The Model 8551, 8555, 8561, 8562, 8564, 8565, and 8566 Refill Kits are intended for use in refilling Medtronic implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps. Recall # Z-1061-2011; 
3) Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual. Recall # Recall # Z-1062-2011
MANUFACTURER: Recalling Firm: Medtronic, Inc. – Neuromodulation, Minneapolis, MN, by letter dated January 2011. MANUFACTURER: Medtronic Puerto Rico Operations Co., Juncos, PR. Firm initiated recall is ongoing.
REASON: This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed? II or SynchroMed EL implantable drug pump refill procedure, and important patient management recommendations that will be added to our PRODUCT labeling. A pocket fill is the inadvertent injection of all or some of the prescribed drug into the patient’s subcutaneous tissue, which includes the pump pocket, instead of the pump. Please share this information with any of your staff that perform pump refills. From May 1996 to September 2010, Medtronic has received 351 reports worldwide related to the occurrence of pocket fills with the SynchroMed infusion system. Assuming pumps are refilled 6 times per year, the reported rate of occurrence per refill opportunity is as high as 1 per 10,000 refill opportunities (0.0101%). The actual occurrence rate is likely to be higher due to under reporting, but the extent of under reporting is unknown. Of the reported events there have been 8 deaths, 270 events requiring medical intervention (serious or life threatening injury), and 58 events not requiring medical intervention (no injury or non-serious injury). There were 15 events in which the patient severity was unknown.

CLASS II

PRODUCT :
1) LightSpeed 16 Computed Tomography X-ray Systems; LightSpeed 16 Computed Tomography X-ray Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications. Recall # Z-0942-2011;
2) GE Discovery ST (16 Slice) System; Discovery ST (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications. Recall # Z-0943-2011;
3) GE Healthcare STe (16 slice) System; Discovery STe (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications. Recall # Z-0944-2011;
4) GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications. Recall # Z-0945-2011;
5) GE Healthcare Discovery LS (16 slice) System; Discovery LS (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications. Recall # Z-0946-2011
MANUFACTURER: GE Healthcare, LLC, Waukesha, WI, by letter beginning October 27, 2010. Firm initiated recall is ongoing.
REASON: Although the system x-ray output is accurate for the technique factors given, and the dose display is also accurate, certain CTDI adjustment factors used for the manual calculation from the Technical Reference Manual (TRM) are incorrect. CTDI100 Aperture Adjustment Factors for 4x0.625 mode contain incorrect values. This issue may lead to inaccurate CTDI manual calculation. The results of the differences could be anywhere from 80% to 106% less dose if calculated manually via the TRM against the actual value.

PRODUCT :
Varian High Energy Linear Accelerator; Model numbers: H14, H27, H29 and HCX; Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-1045-2011

MANUFACTURER: Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on December 10, 2010. Firm initiated recall is ongoing.
REASON: An anomaly was identified whereby the bolts used to fasten the counterweight to the gantry may not, in some cases, be fully tightened to the required torque specification.

PRODUCT :
1) Omnifit M/S PSL Porous Coated Acetabular Shell 40MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0040. Recall # Z-1046-2011;
2) Omnifit M/S PSL Porous Coated Acetabular Shell 42MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0042. Recall # Z-1047-2011;
3) Omnifit M/S PSL Porous Coated Acetabular Shell 44MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0044. Recall # Z-1048-2011;
4) Omnifit M/S PSL Porous Coated Acetabular Shell 46MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0046. Recall # Z-1049-2011;
5) Omnifit M/S PSL Porous Coated Acetabular Shell 48MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0048. Recall # Z-1050-2011;  
6) Omnifit M/S PSL Porous Coated Acetabular Shell 50MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0050. Recall # Z-1051-2011;
7) Omnifit M/S PSL Porous Coated Acetabular Shell 54MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0054. Recall # Z-1052-2011;
8) Omnifit M/S PSL Shell 58 MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0058. Recall # #1053-2011;
9) Omnifit M/S Dual Geom Shell 58 MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2035-0058. Recall # Z-1054-2011;
10) Omnifit PSL M/S 3-Hole Cup, 46MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number S-1790-HA46. Recall Z-1055-2011;
11) Omnifit PSL M/S 3-Hole Cup, 48MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number S-1790-HA48. Recall # Z-1056-2011;
12) Omnifit PSL M/S 3-Hole Cup, 50MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number S-1790-HA50. Recall # Z-1057-2011;
13) Omnifit PSL M/S 3-Hole Cup, 54MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number S-1790-HA54. Recall # Z-1058-2011;
14) Omnifit PSL M/S 3-Hole Cup, 58MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number S-1790-HA58. Recall # Z-1059-2011
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated August 2, 2010. Firm initiated recall is ongoing.  
REASON: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.

PRODUCT :
Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222. The device is intended for use during percutaneous biopsy and drainage procedures to obtain tissues or fluid specimens. Recall # Z-1063-2011
MANUFACTURER: Inrad, Inc., Kentwood, MI, by letter dated December 20, 2010. Firm initiated recal is complete.
REASON: This lot of PRODUCT has the wrong expiration date on the carton label. The pouches contained the correct expiration date.

PRODUCT :
Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version NET VA10A for RTT 4.1.122 or NET V10B for RTT 4.1.125. Intended use: medical charged-particle radiation therapy system . Artiste MV system Part Number 8139789. RT Therapist Part Number 8162815, Therapist Express Basic part number 8151289. Optional parts: Syngo RT Therapist assist part number 8162807, Therapist Express Assist part number 8151297. Recall # Z-1064-2011
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letters beginning July 30, 2009. Firm initiated recall is ongoing.
REASON: Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machines’ are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters.

PRODUCT :
Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No. DS9800. Intended for immunohistochemistry on paraffin-embedded tissue sections. Recall # Z-1065-2011
MANUFACTURER: Recalling Firm: Leica Microsystems, Inc., Bannockburn, IL,  by letters dated November 16, 2010. MANUFACTURER: Leica Biosystems Newcastle Ltd., Newcastle Upon Tyne, United Kingdom. Firm initiated recall is ongoing.
REASON: Users of the Bond Polymer Refine Detection System, DS9800, may experience instances of "weak staining" due to the DAB Part B component, which may give a false negative result

PRODUCT :
Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028; The Piccolo Comprehensive Metabolic Reagent Disc, used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma or serum. The patented self?contained reagent rotors are bar coded, contain liquid diluents and dry reagents and use centrifugal and capillary technology to provide the most commonly requested chemistry panel results in approximately 12 minutes. The Piccolo Comprehensive Metabolic Panel, used with the Piccolo Blood Chemistry Analyzer is a diagnostic system that aids in disease diagnosis or monitoring disease treatment. Recall # Z-1066-2011
MANUFACTURER: Abaxis Inc., Union City, CA, by letter dated November 19, 2010. Firm initiated recall is ongoing.
REASON: Abaxis has determined that during the manufacture of PRODUCT lot 0396BC5 may report inaccurate values of Alanine Aminotransferase (ALT) when used in the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer.

PRODUCT :
Fujinon Endoscope Series; Model # EPX-4400 and EPX-4400HD. Digital processing of images from endoscope. Recall # Z-1067-2011
MANUFACTURER: Fujinon Inc., Wayne, NJ, by letter dated January 7, 2011. Firm initiated recall is ongoing.
REASON: The  FICE feature installed in video endoscopic processors is being disabled since this feature should have been reviewed under premarket notification/510K process.

PRODUCT :
Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), interventional radiology, extracorporeal membrane oxygenation (ECMO), hemofiltration, hemodialysis and critical care. Recall # Z-1093-2011

MANUFACTURER>: International Technidyne Corp., Edison, NJ, by letter dated November 29, 2010. Firm initiated recall is complete.   
REASON: Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot.

PRODUCT :
1) Centurion Medical PRODUCT s Central line procedure tray, CVI3070, Sterile. Recall # Z-1070-2011;
2) Centurion Medical PRODUCT s Central venous catheter pack, CV13225, Sterile. Recall # Z-1071-2011;
3) Centurion Medical PRODUCT s Port access tray, DT12050, Sterile. Recall # Z-1072-2011;
4) Centurion Medical PRODUCT s Port access tray DT6040, Sterile. Recall # Z-1073-2011;
5) Centurion Medical PRODUCT s Port cath tray DT6765, Sterile. Recall # Z-1074-2011;
6) Centurion Medical PRODUCT s Implanted access port tray DT7105, Sterile. Recall # Z-1075-2011;
7) Centurion Medical PRODUCT s Port access tray DT7780, Sterile. Recall # Z-1076-2011;
8) Centurion Medical PRODUCT s VAD access kit HT2415, Sterile. Recall # Z-1077-2011;
9) Centurion Medical PRODUCT s VAD Tray HT1995A, Sterile. Recall # Z-1078-2011;
10) NeoMedical Incorporated, V- Cath Insertion Tray, REF301-00, Sterile. Recall # Z-1079-2011;
11) Centurion Medical PRODUCT s Insertion/PPE Kit CV12590, Sterile. Recall # Z-1080-2011;
12) Centurion Medical PRODUCT s PICC Line Kit CV12880, Sterile. Recall # Z-1081-2011;
13) Centurion Medical PRODUCT s Venous access kit, CV1515, Sterile. Recall # Z-1082-2011;
14) Centurion Medical PRODUCT s Custom PICC insertion tray DT11460, Sterile. Recall # Z-1083-2011;
15) Centurion Medical PRODUCT s Central line procedure kit DT12210, Sterile. Recall # Z-1084-2011;
16) Centurion Medical PRODUCT s Port access tray DT12965, Sterile. Recall # Z-1085-2011;
17) Centurion Medical PRODUCT s PICC line tray DT3185, Sterile. Recall # Z-1086-2011;
18) Centurion Medical PRODUCT s Port access tray DT7030, Sterile. Recall # Z-1087-2011;
19 Centurion Medical PRODUCT s Port access tray DT7150, Sterile. Recall # Z-1088-2011;
20) Centurion Medical PRODUCT s VAD access tray DT7810, Sterile. Recall # Z-1089-2011;
21) Centurion Medical PRODUCT s Port access tray with sorbaview 2000 and chloraprep DT9155, Sterile. Recall # Z-1090-2011;
22) Centurion Medical PRODUCT s Port access tray DT9195, Sterile. Recall # Z-1091-2011;
23) Centurion Medical PRODUCT s VAD access tray HT2440A, Sterile. Recall # Z-1092-2011
MANUFACTURER: Recalling Firm: Centurion Medical PRODUCT s, Howell, MI, by letters on June 3, 2010 and June 21, 2010. MANUFACTURER: Centurion Medical PRODUCT s, Salisbury, NC. Firm initiated recall is complete.
REASON: The kits contain heparin lock flush solution USP code 504505 that is under recall by APP Pharmaceuticals. APP Pharmaceuticals is recalling the heparin because of incomplete documentation associated with test results.

PRODUCT :
Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; Intended use: The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. Recall # Z-1094-2011
MANUFACTURER: Recalling Firm: Abbott Laboratories, Santa Clara, CA, by letter dated October 15, 2010. MANUFACTURER: C2 Diagnostics, Montpellier Cedex 5, France. Firm initiated recall is ongoing.
REASON: There is the potential for the instrument to not power up due to the flash memory issue. This will result in an error message displayed is "No Memory Available" and has the potential for delay in generating patient results.

PRODUCT :
Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00. One single unit to a package. Triathlon Distal Femoral Fixation Pegs are made available separate from the Triathlon Posteriorly Stabilized Femoral Component. These distal femoral fixation pegs are an accessory to the Triathlon Femoral Component and are optional for use. These pegs are designed to provide rotational stability and to aid the surgeon in the placement of the femoral component on the prepared distal femur. The Triathlon Distal Femoral Fixation Pegs are fabricated from wrought cobalt alloy. The distal portion of the fixation peg is thread to allow the peg to be assembled to the distal threaded hole in the Triathlon femoral component. The proximal portion of the peg is recessed to allow the use of a wrench to assemble the peg into the femoral complement. Recall # Z-1095-2011
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated January 6, 2011. MANUFACTURER: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing
REASON: The labels on the Triathlon Distal Femoral Fixation Pegs contain an incorrect expiration date of January 2015 (2015-1) when the actual expiration date should read June 2014 (2014-6)

PRODUCT :
Pulmonary Valve & Conduit SG Used in heart surgery. Recall # Z-1219-2011
MANUFACTURER: CryoLife, Inc., Kennesaw, GA, by letter dated January 7, 2011. Firm initiated recall is ongoing.
REASON: A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.

PRODUCT :
1) Hill-Rom TotalCare Bed, P1900. The TotalCare Bed System is intended to provide patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including but not limited to, acute care, including critical care, step down/progressive care medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU) and sections of the emergency department (ED). Recall # Z-1220-2011;
2) Hill-Rom TotalCare Bariatric Bed, P1840. The TotalCare Bed System is intended to provide patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including but not limited to, acute care, including critical care, step down/progressive care medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU) and sections of the emergency department (ED). Recall # Z-1221-2011
MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated January 19, 2011. Firm initiated recall is ongoing.

REASON: The firm received one report that a patient was weighed on the bed at 53 Kg when the patient actually weighed 73 Kg. The patient expired the next day and it is inconclusive as to whether the scale was a contributing factor. The firm investigated and found that the software for the scale system did not clear the last patient weight from the history of the scale system.

PRODUCT :
Maquet Heartstring Aortic Cutter 4.3 mm, AC-3043. Intended for use by cardiac surgeons during CABG procedures to create an opening in the wall of a vessel. Recall # Z-1222-2011
MANUFACTURER: Recalling Firm: Maquet Cardiovascular, San Jose, CA, by letters on June 10, 2020.    MANUFACTURER: Maquet Puerto Rico Inc., Dorado, PR. Firm initiated recall is ongoing.
REASON: Pouch integrity may be compromised, resulting in loss of sterility.

CLASS III

PRODUCT :
Pump in Style Advanced (PNSA) Breast Pump; a daily use, double pump, electric powered breast pump; the affected breast pumps were sold in the following configurations: a) article 57027 - Kit PNSA Shoulder Bag; b) article 57027T - Kit PNSA Shoulder Bag Tagged; c) article 57036T - Kit PNSA The Metro Bag Tagged; d) article 57043 - PNSA without kit; e) article 57062 - Kit PNSA Backpack; f) article 57062-03 - Kit PNSA Backpack CA/3; g) article 57062T - Kit PNSA Backpack Tagged; h) 57102 - Motor Replacement PNSA Backpack 57062; i) 57103 - Motor Replacement PNSA Shoulder Bag 57027 Intended use: A powered breast pump for the removal, collection and storage of mother's breast milk. Recall # Z-1224-2011
MANUFACTURER: Medela Inc., McHenry, IL, by letter dated January 11, 2011. FDA initiated recall is ongoing. 
REASON: The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise.