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FDA Recalls

Attention all mdi Clients:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 25, 2012.

CLASS I

PRODUCT:

Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. Recall # Z-0296-2012

MANUFACTURER:  Respironics, Inc., Murrysville, PA, by telephone on October 11, 2011. Firm initiated recall is ongoing.

REASON:  Units being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure. This may impact therapy.

CLASS II

PRODUCT:

1) LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single channel EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Model FG-00065 LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. Recall # Z-0206-2012;2) LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a high performance triple channel EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Model FG-00084 LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. The ACT III will provide more sensitive data for initial or early detection of arrhythmia in patients that have minimal or atypical symptoms. Recall # Z-0207-2012;3) ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automatically activated system with a high performance EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; there are two models used with either the ACT 1 sensor or the ACT III sensor: a) Model Ozone-HTC b) Model BlackJack2 SGH-i617 LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. Recall # Z-0208-2012

MANUFACTURER:  Recalling Firm: Lifewatch Services Inc., Rosemont, IL, by letter dated September 27, 2011. Manufacturer: Card Guard Scientific Survival LTD, Rehovot, Israel. Firm initiated recall is ongoing.  

REASON:  LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.

PRODUCT:  SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material. Recall # Z-0209-2012

MANUFACTURER:  SCC Soft Computer, Clearwater, FL, by letter on July 13, 2011. Firm initiated recall is ongoing.

REASON:  SoftPath architecture does not correctly handle AP macros and data fields inside report sections that are stored in the database. Improper information can be displayed in all places where the diagnosis from the database is read and displayed.

PRODUCT:

SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. 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 report laboratory data. Recall # Z-0277-2012

MANUFACTURER:  SCC Soft Computer, Clearwater, FL, by letter on May 3, 2011. Firm initiated recall is ongoing.

REASON:  A client reported the PT and INR results did not get flagged. The PROT should have been flagged as HIGH and the INR should have been flagged as PANIC. Neither test was flagged.

PRODUCT:

Elekta Synergy XVI X-ray Volume Imaging System to be used as part of radiation therapy treatment process. Recall # Z-0342-20212

MANUFACTURER:  Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated October 20, 2011.Manufacturer: Elekta Oncology Systems (Fmrl Philipps). 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) Maquet Servo-i ventilator system Device Part number 64 87 800, 510 k 041223 Device Listing No. B052264. Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. Recall # Z-0352-2012;2) Maquet Servo-S ventilator system Device Part number 66 40 440, 510 k 041223; Device Listing No. B052264. Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. Recall #Z-0353-2012;3) Maquet PC Board PC1772 Spare Part Device Part number 64 67 620, 510 k 041223 Device Listing No. B052264. Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. Recall # Z-0354-2012

MANUFACTURER:  Recalling Firm: Maquet Inc., Wayne, NJ, by letter dated September 19, 2011. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.

REASON:  Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24).

PRODUCT:

RayStation Version 2.0.0.15 Consult instruction for use. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system. Recall # Z-0359-2012

MANUFACTURER:  RaySearch Laboratories AB, Stockholm, Sweden, by letter dated October 19, 2011. Firm initiated recall is ongoing.

REASON:  The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient.

PRODUCT:

1) ActiveCare +SFT Medical Compression Systems. Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema. Device Catalog Number A502B-0001-01 and A502B-0002-01. Recall # Z-0386-2012;2) ActiveCare DVT Medical Compression Systems. Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema. Device Catalog Number A502B-0001-02 and H502B-0001-07. Recall # Z-0387-2012  

MANUFACTURER:  Recalling Firm: Genesis Manufacturing Inc., Fortville, IN, by letters dated September 15, 2011. Manufacturer: Medical Compression Systems, OR Aqiva, Israel. Firm initiated recall is ongoing.

REASON:  MCS has received a limited number of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare DVT and ActiveCare+S.F.T. devices. The firm found that an ActiveCare DVT device may work improperly if connected to a non-MCS AC/DC adaptor with a higher nominal voltage. As specified in each product's User Manual, the ActiveCare DVT devices must only be used with the MCS AC/DC Adaptor. The ActiveCare DVT device could result in the device overheating and render the device unusable.

PRODUCT: 

Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips (wide) 4:1, 10 Intra-oral tips Dental resin cement. Self-etch, self-adhesive resin cement. High bond strength without adhesive needed. Easy to clean up and can be used with all anterior and posterior ceramics, PFMs, and CAD/CAM materials. Color stable and aesthetic. Works with all substrates from opaque to translucent. HSI number 123-7426. Recall # Z-0390-2012

MANUFACTURER:  Henry Schein, Inc., Melville, NY, by letter dated November 10, 2011. Firm initiated recall is ongoing.

REASON:  The specific lots of Maxcem Elite Refill Kit appear not to be authentic.

PRODUCT:

Dental cement under the brand name a) Cement-It, Part No. N33, N33A; and b) Natural Elegance (private label of Cement-It) Part No. SHN9004110. The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural Elegance (private label of Cement-It), are indicated as a luting cement bonding system for porcelain crowns, inlays, and onlays and other dental restorations, including ceramics, metal alloys and composite restoratives. Recall # Z-0454-2012

MANUFACTURER:  Kerr/pentron Dba Kerr Corporation and Pentron Clinical, Orange, CA, by letters dated April 4, 2011 and April 20, 2011. Firm initiated recall is ongoing.

REASON:  Product sets faster than specified in the "Directions for Use" and in release specifications.

PRODUCT:

1) Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 3-Way Stopcock Manifold, Extension Set, 44" (112 cm), Vol. 6.6 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8369. Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0469-2012;2) Baxter Interlink System Continu-Flo Solution Set, 69" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock,, Extension Set, 61" (155 cm), Vol. 8.5 mL, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8371 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0470-2012;3) Baxter Interlink System Extension Set, 20" (51 cm), Vol. 2.9 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8376 Intended use: for the administration of sterile I.V. fluids to the patient. Recall # Z-0471-2012; 4) Baxter Interlink System Vented Continu-Flo Solution Set, 100" (2.5 m), Vol. 2.9 mL, 3 Injection Sites, Male Luer Lock Adapter with Retractable Collar; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8533 Intended use: for the administration of sterile I.V. fluids to the patient. Recall # Z-0472-2012;  5) Baxter Interlink System Y-Type Solution Set, 78" (2.0 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8581 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0473-2012;6) Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8621 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0474-2012;7) Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 2C6605 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0475-2012;8) Baxter Interlink System 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way Stopcock Extension Set, Vol. 6.2 mL, 41" (104 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 2C6921 Intended use: for the administration of sterile I.V. fluids to the patient. Recall # Z-0476-2012;9) Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way Stopcock Extension Set, Vol. 6.2 mL, Length 41" (104 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 2C6931 Intended use: for the administration of sterile I.V. fluids to the patient. Recall # Z-0477-2012;10) Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Extension Set, Vol. 5.6 mL, Length 39" (99 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 2C6951 Intended use: for the administration of sterile I.V. fluids to the patient. Recall Z-0478-2012;11) Baxter Interlink System Solution Set, 67" (1.7 m), Injection Site, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock Manifold, Extension Set, 43" (109 cm), Vol. 6.5 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 3C0039 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall #Z-0479-2012;12) Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock Manifold, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock, Extension Set, 39" (99 cm), Vol. 5.8 mL, Injection Site, Male Luer Lock Adapter, Extension Set, 8" (20 cm), Vol. 1.1 mL, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 3C0142 Intended use: for the administration of sterile I.V. fluids to the patient. Recall Z-0480-2012;13) Baxter Interlink System Straight Type Blood Set with 40 and 150 Micron Dual Screen Filter, Length 86" (2.2 m), Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the removal of micro aggregates from whole blood or red blood cells and transfusion of platelets; product code 4C6832 Intended use: for the removal of micro aggregates from whole blood or red blood cells and transfusion of platelets. Recall # Z-0481-2012;14) Baxter Interlink System Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter, Length 95" (2.4 m), Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the removal of micro aggregates from whole blood or red blood cells and transfusion of platelets; product code 4C6838 Intended use: for the removal of micro aggregates from whole blood or red blood cells and transfusion of platelets. Recall # Z-0482-2012

MANUFACTURER:  Recalling Firm: Baxter Healthcare Corp. Round Lake, IL, by letter dated December 6, 2011.  Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing.

REASON:  During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.

PRODUCT:

Portal Vision, R-Arm with 4D Integrated Treatment Console; Model H80, H81. The Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical landmarks in radiotherapy treatment. Portal Vision will also allow for verification of the exit dose in radiotherapy treatment. Recall # Z-0516-2012

MANUFACTURER:  Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated December 1, 2011. Firm initiated recall is ongoing.

REASON:  An anomaly was discovered when using the 4DITC in combination with an R-Arm to acquire double exposure MV images.

PRODUCT:

Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog number: 502501. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient. Recall # Z-0517-2012

MANUFACTURER:  Recalling Firm: Teleflex Medical, Research Triangle Park, NC, by letter dated December 2, 2011. Manufacturer: Teleflex Medical, Perak, Malaysia. Firm initiated recall is ongoing.

REASON:  Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were received.

PRODUCT:

1) GE Healthcare Definium 8000, Digital Radiographic Systems. Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Auto positioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. Recall # Z-0584-2012;2) GE Healthcare Discovery XR650, Digital Radiographic Systems. System ID SLQDSC1. Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Auto positioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. Recall # Z-0585-2012

MANUFACTURER:  GE Healthcare, LLC, Waukesha, WI, by letter dated November 17, 2011. Firm initiated recall is ongoing.

REASON:  The patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. This could permit the arm to swing freely when the rotating arm locking lever is released. Should this happen during use, injury to the patient and/or user could occur.

PRODUCT:

1) DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraMax Stacked Tip 22 cm Str. Basic Kit, Catalog No./REF 10302802, STERILE. The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0586-2012;2) DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraMax Stacked Tip 24 cm Str. Basic Kit, Catalog No./REF 10302803, STERILE --- The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0587-2012;3) DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraMax Stacked Tip 28 cm Str. Basic Kit, Catalog No./REF 10302804, STERILE --- The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0588-2012;4) DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip), DuraMax Stacked Tip 32 cm Str. Basic Kit, Catalog No./REF 10302805, STERILE --- The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0589-2012;5) DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip), DuraMax Stacked Tip 36 cm Str. Basic Kit, Catalog No./REF 10302806, STERILE --- The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0590-2012

MANUFACTURER:  AngioDynamics, Inc., Queensbury, NY, by letter dated January 28, 2011. Firm initiated recall is ongoing.

REASON:  AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.

PRODUCT:

1) Orbit and Orbit Micro Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our devices within an outer container. Removal of the wipes will not compromise the sterile barrier of our device and can easily be identified and replaced. Recall # Z-0592-2012;2) IV Start Kits Convenience kit for starting IVs. Triad wipes are packaged within the sterile barrier and would require compromising the barrier to replace the wipe. Recall # Z-0593-2012

MANUFACTURER:  ICU Medical, Inc., San Clemente, CA, by letter dated March 2, 2011. Firm initiated recall is ongoing.

REASON:  The Triad alcohol prep pads have the potential contamination of the bacteria, Bacillus cereus. The Triad Group alcohol prep pads have been copackaged and distributed with ICU Medical Orbit subcutaneous infustion sets, Orbit Micro subcutaneous infusion sets, and IV Start kits. This recall involves those products marked as sterile as well as non-sterile.

PRODUCT:

1) Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA. The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. Recall # Z-0647-2012;2) Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog No. 10013, UPN/Product No. H965100131, STERILE --- Package/Box Units: Box of 5 each --- Made in USA. The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. Recall # Z-0648-2012

MANUFACTURER:  Recalling Firm: Navilyst Medical, Inc., Glens Falls, NY, by letter dated February 4, 2011.   Manufacturer: Navilyst Medical, Inc., Glens Falls, NY;Medventure Technology Corp., Jeffersonville, IN. Firm initiated recall is complete.

REASON:  The Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated.

PRODUCT:

1) Weck, DuraHook (6mm) and (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater. Catalog numbers: 382800. Recall # Z-0677-2012;2) Weck, DermaHook (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater. Catalog number: 382805. Recall # Z-0678-2012

MANUFACTURER:  Recalling Firm: Teleflex Medical, Research Triangle Park, NC, by letter dated December 6, 2011. Manufacturer: Teleflex Medical, Tecate, Mexico. Firm initiated recall is ongoing.

REASON:  Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there is a chance for operative exposure, loss of the band in the operative field as well as inadvertent needle stick.

PRODUCT:

NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue software is intended to aid the hospital in tracking patient data from collection to review to archive. The NicVue Software includes the following features and intended uses: Launch Applications, Enter patient information, Import/Export patient information from the Hospital Information System, Move data files, Archive data files on DVD or CDROM. Part Numbers: 828-050000, 828-062400, 828-062500, 828-062600, 828-050100, 828-062900, 828-063100, 828-063200, 828-063300, 828-063500. Recall # Z-0737-2012

MANUFACTURER:  Recalling Firm: CareFusion 209 Inc., Middleton, WI, by letter dated December 16, 2011.  Manufacturers: CareFusion 209 Inc., Middleton, WI;

VIASYS Healthcare-Intermed Precision Subsidiary, Galway, Ireland.  Firm Initiated recall is ongoing.

REASON:  CareFusion recently discovered that NicVue versions 2.9.2 and 3.0.1 contains a software issue that may affect some workflows. To prevent this possibility, your NicVue version 2.9.2 must be updated to 2.9.3 and 3.0.1 must be updated to NicVue version 3.0.2. Under certain work flow processes, when selecting a new patient name in NicVue, the associated exams list may not properly refresh, and may continue to display the previous patient's exams. When the exam record is opened in the device application software, the correct patient name associated with that record is displayed at the top of the screen, but it may not be the intended patient's record.

PRODUCT:

Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101). The Liebel Flarsheim Illumena 150mL Syringes with Handi-Fil Straw are 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; Catalog # 900103. Recall # Z-0830-2012

MANUFACTURER:  Mallinckrodt Inc., Cincinnati OH, by letter dated October 11, 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 Illumena 150mL Syringe with Handi-Fil Straw, product 900101.

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:  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.

PRODUCT:

Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy during endoscopic procedures. Catalog number 7501669. Recall # Z-0806-2012

MANUFACTURER:  Recalling Firm: Olympus America Inc., Center Valley, PA, by letter dated December 12, 2011. Manufacturer: KeyMed (Medical and Industrial Equipment) Ltd. Southend-On-Sea, UK. Firm initiated recall is ongoing.

REASON:  Water may leak from the irrigation tubing used on the Olympus Flushing Pump.

PRODUCT:

NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx. The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician. Recall # Z-0826-2012

MANUFACTURER:  Recalling Firm: NxStage Medical, Inc., Lawrence, MA, by telephone on December 13, 2011, and by letter dated December 14, 2011. Manufacturer: Medimexico, S. de R.L. de C.V., Tijuana, Mexico. Firm initiated recall is on going.

REASON:  Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 18, 2012.

CLASS II

PRODUCT:
Varian Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators. 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. Model numbers: H14, H18, H27 and H29. Recall # Z-0181-2012

MANUFACTURER:Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated September 9, 2011. Firm initiated recall is ongoing. 

REASON:Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automate mode.

PRODUCT:

1) Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; The MDM Liner and X3 Acetabular Inserts is a sterile single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads. Catalog No. 626-00-XXY (XXY= 36C, 38D, 42E, 46F, 48G, 52H, 54I, 58J). Recall # Z-0192-2012;2) Stryker Restoration ADM System X3 Acetabular Insert. The Restoration ADM System X# Acetabular Insert is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 28mm diameter femoral heads. Catalog No.: 1236-2-8XX (XX=46, 48, 50, 52, 54, 56, 58, 60, 62, 64). Recall # Z-0193-2012;3) Stryker Restoration ADM System; The Restoration ADM is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads. Catalog No: 1235-2-8XX (XX+48, 50, 52, 54, 56, 58, 60, 63, 64). Recall # Z-0194-2012

MANUFACTURER:Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated June 3, 2011.Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.

REASON:There is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.

PRODUCT:

1) SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter*** REF Cat No.***Lot***Use By***Assembled in Mexico, USA***EC***REP*** Cordis Cashel, ***Cordis***a Johnson&Johnson company***" UPN H739532598A3, Cat No 532-598A, No. MB 10, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H739532598B3, Cat No 532-598B, No. MB 20, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H73953298C3, Cat No 532-598C, No MB 20 French Size 5, Shape (PIG), Length, cm 65, Flow Rate, ml/sec, 30, Side Holes 6. UPN H73953298D3, Cat No 532-598D, No MB 2 French Size 5, Shape (PIG), Length , cm 70, Flow Rate, ml/sec, 30, Side Holes 10. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system. Catalog No. 532-598A and 532-598B. Recall # Z-0204-2012;2) SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN end***Sideholes***SPECIAL***Angiographic Catheter*** REF Cat No.***Lot***Use By***STERIAL EO***Assembled in Mexico***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson company***" UPN SRD5724MB, No MB 2, Length, cm 100, Sideholes 2. UPN SRD5727MB, No MB 4, Length, cm 80, Sideholes 4. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system. Catalog No. 532-598A and 532-598B. Recall # Z-0205-2012

MANUFACTURER: Cordis Corp., Miami Lakes. FL, by letter dated November 2011. Firm initiated recall is ongoing.

REASON:Marker bands dislodged during a procedure.

PRODUCT:

Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart module), Reference/FSCA Identifier: CP-05277, 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-0370-2012

MANUFACTURER:Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated October 31, 2011. Firm initiated recall is ongoing.

REASON:An anomaly has been identified with Varian Eclipse and RT Chart where adding a reference point in RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction in Eclipse.

PRODUCT:

Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade. Catalog number: 532.026. Recall # Z-0348-2012

MANUFACTURER:Synthes USA (HQ), Inc., West Chester, PA, by letter dated October 17, 2011. Firm initiated recall is ongoing.

REASON:The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece, there is a potential for injury to the patient and/or user.

PRODUCT:

Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens Accommodating Posterior Chamber Intraocular Lens PMA No.: P030002. The Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. Recall # Z-0445-2012

MANUFACTURER:Bausch and Lomb, Inc., Aliso Viejo. CA, by letter dated November 14, 2011. Firm initiated recall is ongoing.

REASON:Bausch + Lomb voluntary initiated the recall due to a physician complaint of haze on the Crystalens AO which was visualized using an angled beam from a slit lamp during the post-operative examination.

PRODUCT:

1) Microcyn Solution with Preservatives (Rx), a) Part number: 84798, 16.9 fl oz (500 mL) and b) Part number: 84781; 33.5 fl oz. (990 mL) Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L), Hypochlorous acid (H0CL) (30 mg/L) -Non Foaming -Does not contain antibiotics - Does not facilitate resistance - No known drug/treatment interactions or contraindications -laboratory proven in solution inactivation of bacteria, viruses, fungi and spores. Performance testing: Microcyn Solution with Preservatives has been evaluated by the USP <51> antimicrobial Effectiveness Test and in Time-Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a category 1 product. Intended to be used by health care professionals in the management in wounds. Recall # Z-0448-2012;2) Puracyn OTC; Wound & Skin Care Solution with Preservatives; a) Part number: 6000; 80003 (8 oz trigger spray); b) Part number: 6002; 80001, (8 oz finger pump); c) Part number: 6004; 80005, (16 fl oz pump with insert). Kills 99.99% of Staph, MRSA, Strep and other Infectious Germs in 30 seconds in solution. Does not contain Antibiotics, Steroids or Alcohol. -Cleans infected wounds in one step - Safe to use around eyes, nose, m mouth and open wounds - Accelerated healing of minor wounds by keeping the wound clean -Non-toxic and non-irritating. Made in USA. Intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin. Recall # Z-0449-2012;3) Microcyn Dermatology Spray with germ killing Preservatives (Rx); Part number: 84866 - 8 fl oz spray bottle. 99.999% Reduction In-solution in 30 seconds. MRSA - Staphylococcus aureus VFR - Enterococcus faecalis Acinetobacter baumannii Pseudomonas aeruginosa. Microcyn Dermatology Spray has been evaluated by the USP <51> Antimicrobial Effectiveness Test and in Time Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a Category 1 product. Safe to use around eyes, nose and mouth. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care professionals in management via debridement of wounds. Recall # Z-0450-2012;4) Microcyn Dermatology HydroGel, Spray, a) Part number: 84811 - 1.76 oz. and b) Part number 84828, 4 oz. Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination. Antibiotic-free, steroid-free and biodegradable. Intended for use by health care professionals in management of wounds including itch and pain relief associated with dermal irritation, sore, injuries and ulcers or dermal tissue. Microcyn Skin and Wound hydrogel is intended for use on first and second degree burns, excluding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds. Recall # Z-0451-2012

MANUFACTURER:Oculus Innovative Sciences Inc., Petaluma, CA, by letter dated November 15, 2011. FDA initiated recall is ongoing.

REASON:Unapproved drug claims and those not approved under 510K clearance.

PRODUCT:

1) Urine Reagent Strips (URS) 10 Parameters URS-l0-1OOW 510(K) number: K970250 Devise Listing number: D072377. Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label on the bottle and the bottle placed inside a Teco Diagnostics Box. For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine. Recall # Z-0511-2012;2) Urine Reagent Strips (URS) 10 Parameters URS-l0-1OOW 510(K) number: K970250 Devise Listing number: D072377 Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label on the bottle and the bottle placed inside a Teco Diagnostics Box. For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine. URS-II-I00G-00I i. 3. Recall # Z-0512-2012

MANUFACTURER:Teco Diagnostics, Anaheim, CA, by letter dated October 14, 2011. Firm initiated recall is ongoing.

REASON:This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets (Refer to next paragraph). Sampling size submitted for QC testing was insufficient based upon number of rolls manufactured.

PRODUCT:

The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. Recall # Z-0518-2012

MANUFACTURER:Recalling Firm: Intersurgical Inc., Liverpool, NY, by letter dated February 8, 2011,Manufacturer: Intersurgical Ltd. – Guernsey, Guernsey, UK. Firm initiated recall is complete. 

REASON:Intersurgical Incorporated has issued a voluntary recall of the IS Cans Carbon Dioxide Absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system.

PRODUCT:

Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger Catalog Number: 72203299. Table, Operating-room, Pneumatic. Recall # Z-0519-2012

MANUFACTURER:Recalling Firm: Smith & Nephew, Inc. Endoscopy Division, Andover, MA, by letter dated July 26, 2011.Manufacturer: Tenet Medical Engineering, Calgary, Canada. Firm initiated recall is complete.

REASON:SPIDER2 may unlock (loss of traction) resulting in potential movement of the patient when the device is within close proximity to an RF source. Loss of traction can potentially result in the unintended repositioning of the extremity and potential for tissue or cartilage damage.

PRODUCT:

Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers have the same intended use as the predicate devices. They are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standard needle phosphor image plates and can be used with either Musica or Musica 2. In the US, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography. Model No. 5170/100. Recall # Z-0591-2012

MANUFACTURER:Recalling Firm:AGFA Corp., Greenville, SC, by letter dated December 6, 2011.Manufacturer: Agfa-Gevart NV, Mortsel, Belgium. Firm initiated recall is ongoing.

REASON:Occasionally images can be lost or sent to an incorrect folder or the digitizer may stop either during startup or during a cassette scan cycle.

PRODUCT:

0.9% Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only, sterile fluid path; 10 mL Single-Use Syringe with Male Luer Lock, 100 syringes per pack, 4 packs per case; list no. 1978-20 lock flush solution. Recall # Z-0596-2012

MANUFACTURER:Recalling Firm: Hospira Inc., Lake Forest, IL, by letter dated November 18, 2011.Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.

REASON:There is particulate matter in the fluid pathway, which has been identified as the same material as the rubber tip of the syringe plunger.

PRODUCT:

ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. Salter Labs Nasal Cannula (Adult), Salter Style with modified nasal prongs. w/7' O2 line and 7' CO2 line with male luer lock connector. Recall # Z-0605-2012

MANUFACTURER:Salter Labs, Arvin, CA, by telephone on December 7, 2011. Firm initiated recall is ongoing.

REASON:Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors).

PRODUCT:

Eius Unicompartmental Knee System. Intended for use in Unicompartmental Knee Arthroplasty (UKA). Surgeon users have identified the following potential advantages of UKA procedures versus Total Knee Arthroplasty procedures generally: conservation of the opposite compartment, preservation of ligaments and patellofemoral articulation, reduced loss of bone stock and lower implant cost. The EIUS UKA is a Resurfacing device that requires the removal of a thin condylar cross-section intended to replace the diseased cartilage only. This allows the surgeon to conserve good quality subchondral bone. Recall # Z-0606-2012

MANUFACTURER:Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters dated August 17and 25, 2011. Firm initiated recall is ongoing.

REASON:Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices.

PRODUCT:

SKYLight Imaging Systems, Model 882050; Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Recall # Z-0607-2012

MANUFACTURER:Recalling Firm: Philips Medical Systems, San Jose, CA, by letter dated December 08, 2011.Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. Firm initiated recall is ongoing.

REASON:During preventative maintenance, a crack was discovered in the lower portion of the old style, non-common arm for the detector assembly, which could result in the detector dropping in an uncontrolled manner.

PRODUCT:

1) STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. For controlling the infusion of Intravenous fluids into the human body. Recall # Z-0629-2012;2) STAT 2 Extension Set Gravity Flow Controller, 12" length, Catalog/REF No. S2-12, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. Recall # Z-0630-2012;3) STAT 2 Extension Set Gravity Flow Controller (Needle-Free), 12" length, Catalog/REF No. S2-12N, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. Recall # Z-0631-2012;4) STAT 2 Primary Administration Set Gravity Flow Controller, 20 Drops/cc, 84" length, Catalog/REF No. S2V-20, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. Recall # Z-0632-2012;5) STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/cc, 84" length, Catalog/REF No. S2V-20 N, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. Recall # Z-0633-2012;6) STAT 2 Secondary Set Gravity Flow Controller, 20 Drops/cc, 13" length, Catalog/REF No. S2-20 MD, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. Recall # Z-0634-2012;7) STAT 2 Primary Administration Set Gravity Flow Controller, 60 Drops/cc, 84" length, Catalog/REF No. S2V-60, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. Recall # Z-0635-2012;8) STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/cc, 84" length, Catalog/REF No. S2V-60 N, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. Recall # Z-0636-2012

MANUFACTURER:Recalling Firm: ConMed Corp., Utica, NY, by letters dated April 14, 2011, April 22, 2011 and May 10, 2011.  Manufacturer: Consolidated Medical Equipment Co., Chihuahua, Mexico. Firm Initiated recall is ongoing.

REASON:Certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates.

PRODUCT:1) Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes per case; Made in China; Zee Part No.: 3061 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants. Recall # Z-0679-2012;2) Zee Clear Vinyl Medical Examination Gloves, Powder Free, Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Made in China; Zee Part No.: 3062 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants. Recall # Z-0680-2012;3) Zee Clear Vinyl Medical Examination Gloves, Powder Free, X-Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Made in China; Zee Part No.: 3063 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants Recall # Z-0681-2012

MANUFACTURER:Recalling Firm: Cypress Medical Products LLC, McHenry, IL, by telephone and letters dated November 14, 2011.  Manufacturer: QINGDAO LANGHUI Import and Export Co, LTD, Qingdao, China. FDA initiated recall is ongoing.

REASON:The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.

PRODUCT:

1) Biomet Series A Thin Patella size 25mm, three pegs, Part 184780, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems. Knee joint patellofemorotibial, cemented, polymer /metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0695-2012;2) Biomet Series A Standard Patella size 25mm, one peg, Part 184700, Sterile. Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. For use with Vanguard, Maxim, Ascent & ACG knee system. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0696-2012;3) Biomet Series A Standard Patella size 28mm, one peg – 184702. For use with Vanguard, Maxim, Ascent & ACG Knee system. Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0697-2012;4) Biomet Series A Thin Patella size 25mm, one peg - 184720 Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0698-2012;5) Biomet Series A Thin Patella size 25mm, one peg - 184720, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0699-2012;6) Biomet Series A Standard Patella size 25mm, three pegs - 184760, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0700-2012;7) Biomet Series A Standard Patella size 28mm, three pegs - 184762, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0701-2012;8) Biomet Series A Thin Patella size 28mm, three pegs - 184782, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0702-2012;9) Biomet Series A Asymmetrical Patella size 25mm, three pegs - 184790, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0703-2012;10) Biomet Series A Asymmetrical Patella size 28mm, three pegs – Part 184791, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0704-2012

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

REASON:Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.

PRODUCT:

U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Acetabular Instrument Kit. The Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Hex Head Drive is used to place the screw that affixes the acetabular cup to the hip acetabulum. Recall # Z-0740-2012

MANUFACTURER:Recalling Firm: Ortho Development Corp., Draper, UT, by letter dated December 19, 2011.Manufacturer: Symmetry Medical USA, Inc., Warsaw, IN. Firm initiated recall is ongoing.

REASON:Tip of hex-head screwdriver may break off during use in hip replacement procedure.

PRODUCT:

Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures during flexible gastrointestinal endoscopy. Recall # Z-0747-2012

MANUFACTURER:Recalling Firm: Olympus America Inc., Center Valley, PA, by letter dated November 28, 2011.Manufacturer: Celon AG Medical Instruments, Teltow, Germany. Firm initiated recall is ongoing.

REASON:Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100

CLASS III

PRODUCT:

MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, STERILE, COMMON/USUAL NAME: Percutaneous, implanted, long-term intravascular catheter; CLASSIFICATION NAME: Percutaneous, implanted, long-term intravascular catheter; Device Listing # D095274. PICC Catheters are utilized for Short or Long Term peripheral access to the Central Venous system for intravenous therapy and power injections of contrast media. Recall # Z-0467-2012

MANUFACTURER:Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letter dated December 2, 2011.Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.

REASON:AngioDynamics distributed the affected PICC catheters that were beyond their expiration date.

PRODUCT:

MAQUET QUADROX iD PEDIATRIC -OXYGENATOR: BEQ-HMOD 3000; Made In Germany The diffusion membrane oxygenator Quadrox iD pediatric is intended for use in an extracorporeal perfusion system. The oxygenator is designed for a blood flow rate of 0.2 -2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature.The utilization period for this device is restricted to six hours. Recall # Z-0689-2012

MANUFACTURER:Maquet Cardiovascular Us Sales, LLC, Wayne, NJ, by letter dated September 22, 2011. Firm initiated recall is ongoing.

REASON:There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oygenator.

PRODUCT:

GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical). Recall # Z-0705-2012

MANUFACTURER:Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated December 20, 2011.  Manufacturer: GE Medical Systems Information Tecnology, Wauwatosa, WI. Firm initiated recall is ongoing.  

REASON:GE Healthcare has recently become aware of a potential safety issue associated with the data of your LOGIQ E9 system that may impact patient safety. 1 User may notice an image from a different patient, or an image from the current patient with title information from a different patient. 2 Incorrect measurements/calculations on images, when viewed on the off-line review station. As a result imaging may need to be repeated due to the confusion in the image information.

PRODUCT:

Outer Carton labeled in part: "1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM***Contact Lenses for Daily Wear***D -1.50***-1.25 100***2016/07***BC 8.5***DIA 14.5***Made in USA***" Individual Lenses labeled in part: "***1-DAY ACUVUE MOIST FOR ASTIGMATISM WITH LACREON***BC 8.5***DIA 14.5***AXIS -1.75 -0.75***080***2016/06***" It is intended for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism. Recall # Z-0734-2012

MANUFACTURER:Johnson & Johnson Vision Care, Inc., Jacksonville, FL, by letter dated December 1,  2011. Firm initiated recall is ongoing.

REASON:Johnson & Johnson Vision Care, Inc. recalled their 1-DAY ACUVUE MOIST Brand Contact Lenses for ASTIGMATISM due to a lot being mixed. The secondary carton lot number and power are not the same as on the primary package inside the carton.

PRODUCT:

1) Varian brand 4D Integrated Treatment Console (4DITC) v10.2.3, Reference/FSCA Identifier: CP-06873, Model Number: H51. The 4D Integrated Treatment Console [4DITC] is designed to interface to the Varian Clinac Treatment Control System [TCS] for the purpose of providing verification of treatment parameters, imaging and providing a record of treatment. The general function of the 4D Integrated Treatment Console is to allow treatment plans and images to be retrieved from the Oncology Information System [OIS] and sent to the TCS, planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy and treatment history to be recorded in the OIS for use and display. The Barcode Conical Collimator Verification [BCCV] device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place. Recall # Z-0715-2012;2) Varian brand Barcode Conical Collimator Verification (BCCV) v1.0, Reference/FSCA Identifier: CP-06873, Model Number: HB. The 4D Integrated Treatment Console [4DITC] is designed to interface to the Varian Clinac Treatment Control System [TCS] for the purpose of providing verification of treatment parameters, imaging and providing a record of treatment. The general function of the 4D Integrated Treatment Console is to allow treatment plans and images to be retrieved from the Oncology Information System [OIS] and sent to the TCS, planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy and treatment history to be recorded in the OIS for use and display. The Barcode Conical Collimator Verification [BCCV] device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place. Recall # Z-0716-2012

MANUFACTURER:Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated December 12, 2011. Firm initiated recall is ongoing.

REASON

When multiple conical collimator treatment plans are scheduled to be treated in a session, the Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the 4DITC. However, the name of the plan is not being updated correctly

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  January 11, 2012.

CLASS I

PRODUCT:

1) St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to monitor and regulate a patients heart rate by providing pacing therapy and/or tachyarrhythmia therapy. Recall # Z-0457-2012;2) St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata (7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to monitor and regulate a patients heart rate by providing pacing therapy and/or tachyarrhythmia therapy. Recall # Z-0458-2012

MANUFACTURER:St Jude Medical CRMD, Sylmar, CA, letters dated November 28, 2011, November 29, 2011, and December 15, 2010. Firm initiated recall is ongoing.

REASON:The recall was initiated because St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on externalized conductors.

PRODUCT:

AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. Prescription Use: Federal law restricts the sale of this device except by or on order of a physician. Each of the affected devices is individually serialized. Recall # Z-0510-2012

MANUFACTURER:Recalling Firm: Carefusion 211 Inc., Yorba Linda, CA, by letter dated September 25, 2011.  Manufacturer:Carefusion 207, Inc., Palm Springs, CA. Firm initiated recall is ongoing.

REASON:The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Carefusion is voluntarily initiating a field correction of the affected devices to preclude the possibility of this risk.

CLASS II

PRODUCT:

1) "***BIOMET 3i***REF AC4425***Conical 25 ANGLED ABUTMENT***4.1mm (D) X 4mm (H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1' ***". Attach an implant to an implant restoration. Recall # Z-0158-2012;2) "***BIOMET 3i***REF SWCA62***Conical Abutment Gold Standard ZR***6mm(D) X 2mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1'***". Attach an implant to an implant restoration. Recall # Z-0159-2012

MANUFACTURER:Biomet 3i, LLC, Palm Beach Gardens, FL, by letter dated September 28, 2011. Firm initiated recall is ongoing.

REASON:The packaging for the referenced products may not have been completely sealed prior to shipment.

PRODUCT:

Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.Part number 01.812.001 - T-PAL Instrument and Implant Set. Recall # Z-0161-2012

MANUFACTURER:Synthes USA (HQ), Inc., West Chester, PA, by letter dated September 23, 2011. Firm initiated recall is ongoing.

REASON:LABELING CORRECTION for Medical Device - previous labeling and promotional materials associated with the T-PAL Spacer system reference the use of T-PAL spacer with allograft material. T-PAL Spacer is currently indicated for use with autograft material. All accounts with record of receiving T-PAL Implant will receive notification of the labeling correction and a copy of the updated brochure. All Synthes Spine Sales Consultants will receive notification of the labeling correction and a copy of the updated brochure.

PRODUCT:

Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data. Model Number 882488: EBW NM Special Model Number 882489: Extended Brilliance Workspace NM Model number 728260: Extended Brilliance Workspace. Recall # Z-0182-2012

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

REASON:A problem related to a software error has been detected. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur.

PRODUCT:

PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box. Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the INRatio Starter Kit Product Model Number: 0200086, 0200432, 0100007, 0100072 The Alere INRatio2 PT/INR Home Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio2 PT/INR Home Monitoring System is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio2 PT/ INR Home Monitoring System is not intended to be used for screening purposes. The Alere INRatio2 PT/INR Home Monitoring System should only be used with a prescription from your physician. The INRatio2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio2 PT Monitoring System is not intended to be used for screening purposes. The INRatio2 PT Monitoring system should only be used with a prescription from your physician. The INRatio system performs Prothrombin Time (PT) testing on fresh, capillary whole blood. The PT test is the principle assay used to monitor warfarin therapy. Patients taking warfarin and other oral anticoagulants should consult with their healthcare provider before adjusting their dosage. The thromboplastins used in performing PT tests can vary substantially causing differences in results between methods. The International Normalized Ratio (INR) is a mathematical correction of the PT result that adjusts for differences in thromboplastins. Consult your physician for the appropriate therapeutic range for you. Recall # Z-0188-2012

MANUFACTURER:Alere San Diego, San Diego, CA, letter dated October 6, 2011. Firm initiated recall is ongoing.

REASON:Alere has initiated a recall due to the potential presence of low levels of the microorganism Bacillus cereus.

PRODUCT:

EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot# 8603EXP.3-EHEC-Enzyme Conjugate 10.0ml Lot# 8604EXP.4-Substrate II 12.5ml Lot# 1601EXP.5-Stop-Solution II 10.0 ml Lot# 1601EXP.6-EHEC Positive Control 3.4 ml Lot# 8601EXP.7-EHEC Negative Control 3.4 ml Lot# 1603EXP.8-96 transfer pipettes-1 Microwell holder-3 Microwell strip sealers The Premier EHEC test kit is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II (verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. Coli (EHEC) infections. Recall # Z-0203-2012

MANUFACTURER:Meridian Bioscience Inc., Cincinnati, OH, by letter dated October 11, 2011. Firm initiated recall is ongoing.

REASON:Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested, however, the rate of occurrence will likely impact clinical sensitivity as defined by product registration and associated instructions for use.

PRODUCT:

VNS Therapy Aspire HC Generator and VNS, Model 105 For implantation in humans to treat Epilepsy and Depression. Recall # Z-0210-2012

MANUFACTURER:Cyberonics, Inc., Houston, TX, by letter on August 15, 2011, and on September 19, 201l. Firm initiated recall is ongoing.

REASON:The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.

PRODUCT:

IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2. Recall # Z-0211-2012

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:Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable.

PRODUCT:

PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads. Hook-up kits that contain the affected alcohol prep pads are as follows: Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; Aria, Kit Part number 23189-106, Kit, Aria Hookup; Aria, Kit Part number 23189-110, Kit, Aria Hookup; Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; 483, Kit Part number 23189-117, Kit, Holter Hookup 483; Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; EVO, Kit Part number SK10456, Sample Kit, Disposables. A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape. Recall # Z-0262-2012

MANUFACTURER:Del Mar Reynolds Medical, Ltd., Hertford, United Kingdom, by letter dated October 21, 2011. Firm initiated recall is ongoing.

REASON:The non-sterile alcohol prep pads (B339) are included in Spacelabs Healthcare hook-up kits may have the presence of a bacterium, Bacillus cereus. These alcohol prep pads were manufactured and recalled by Professional Disposables International (PDI).

PRODUCT:

1) Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243. The recalled device systems are equipped with Version 3.5 Beta 1 software. Recall # Z-0334-2012;2) Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231. The recalled device systems are equipped with Version 3.5 Beta 1 software. Recall # Z-0335-2012

MANUFACTURER:Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by a 'Field Change Order' (FCO #72800531) on September 12, 2011 and a letter dated October 17, 2011. Firm initiated recall is ongoing.

REASON:Software errors. A number of non-conformances were found for the Brilliance Big Bore and Brilliance 64 Computed Tomography X-ray Systems equipped with software version; 3.5 Beta1. The non-conformances stem from software errors identified in the operating software.

PRODUCT:

Odyssey A radiation treatment planning system. Recall # Z-0345-2012

MANUFACTURER:PerMedics, Inc., San Bernardino, CA, by letter dated November 4, 2010. Firm initiated recall is ongoing.

REASON:Anomaly 1 - Invalid Export of Beam Table and or Collimator Angle for DICOM RT Ion, DICOM Image and RTP Link export files: During PerMedics' internal code reviews for lEC 61217 compliance verification, an issue was identified by PerMedics engineers in three export files: D1COM RT Ion Plan, D1COM RT Image and RTP Link. In some cases, this issue can result in table and/or collimator angle values to be exported that are not in compliance with either the lEC 61217 standard or the PerMedics D1COM Conformance Statement. Within Odyssey, the table angle increases counterclockwise (when viewed from Odyssey's "Beam's Eye View" feature) in compliance with the IEC 61217 Patient Support coordinate system. Likewise, within Odyssey, the collimator angle increases counterclockwise (when viewed from Odyssey's "Beam's Eye View" feature) in compliance with the IEC 61217 Beam Limiting Device coordinate system. Through its internal investigation, PerMedics discovered that Odyssey does not export the correct table and/or collimator angles to DICOM RT Ion Plan, DICOM RT Image and RTP Link when the treatment machine's table angle and/or collimator angle increase in the clockwise direction--opposite of the IEC 61217 and Odyssey's internal angle systems. In these cases, Odyssey converts the table and collimator angles to the treatment machine's angle system, which does not match IEC 61217. This conversion should never be performed for these files. Because Odyssey's DICOM and RTP Link exports are supposed to express angles in IEC 61217 coordinates, this conversion results in incorrect table and collimator angle values when the table and collimator angle systems of the beam's machine do not match Odyssey's internal angle systems. Note: If the actual treatment machine's table angle and collimator angle increases in the same direction as Odyssey's internal table angle and collimator angle system, then the conversion is not performed, and these files contain the correct table and collimator angle values. The following conditions must all be present in order for an invalid table angle to be exported for a beam: “The internal table angle of the beam displayed in Odyssey is not equal to zero. " The table angle system for the beam's machine is defined in Odyssey's MakeLib to increase in the clockwise direction when viewed in "Beam's Eye View". "The beam is exported to a DICOMRT Ion Plan, DICOMRT Image, or RTP Linkfile. If anyone of these conditions is not met, then the anomaly does not occur for table angles exported for a beam. The following conditions must all be present in order for an invalid collimator angle to be exported for a beam: “The internal collimator angle of the beam displayed in Odyssey is not equal to zero.” The collimator angle system for the beam's machine is defined in Odyssey's MakeLib to increase in the clockwise direction when viewed in "Beam's Eye View". “The beam is exported to a DICOMRT Ion Plan or RTP Linkfile. If anyone of these conditions is not met, then the anomaly does not occur for collimator angles exported for a beam. Anomaly 2 - Incorrect Monitor Unit Values when Changing Treatment Start Date: If the treatment start date is changed for a patient's fully computed IMRT plan, IMAT plan or a plan containing a "Region DVH" prescription, then Odyssey automatically re-computes the treatment schedule. However, this automatic re-computation also changes the monitor unit values in the schedule so they are no longer correct. In these cases it is necessary to manually perform a full re-computation of the plan to calculate the correct monitor unit values for the treatment schedule; however, Odyssey does not provide indication to the user of this anomaly, and allows export of the plan with these incorrect monitor unit values.

PRODUCT:

1) Product is labeled in part - Pouch label: "***ORTHOFIX***Description: Origen***DBM Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***" Product is labeled in part - Carton label: "***Origen DBM with Bioactive Glass***REF***ID*** Expiration*** Rx Only***ONE EACH***" Origen DBM with Bioactive Glass Catalog #: a) 22-2002 (2cc size); b) 22-2005 (5cc size); c) 22-2010 (10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis). Recall # Z-0346-2012;2) Product is labeled in part - Pouch label: "***NanoFUSE***DBM*** Description: NanoFUSE DBM***Size***Order No.:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only*** nanotherapeutics***" Product is labeled in part - Carton label: "***NanoFUSE DBM***Order No:***ID***Expiration***nanotherapeutics***Rx Only***ONE EACH***" NanoFUSE DBM Catalog #:a) NAN109-02 (2cc size); b) NAN109-05 (5cc size); c) NAN109-10(10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that is not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis). Recall # Z-0347-2012

MANUFACTURER:Nanotherapeutics, Inc., Alachua, FL, by letter dated April 12, 2011. Firm initiated recall is ongoing.

REASON:The products were manufactured without an approved 510k. Direct accounts were notified of the recall on 04/08/2011.

PRODUCT:

Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade. Catalog number: 532.026. Recall # Z-0348-2012

MANUFACTURER:Synthes USA (HQ), Inc., West Chester, PA, by letter dated October 17, 2011. Firm initiated recall is ongoing. 

REASON:The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece, there is a potential for injury to the patient and/or user.

PRODUCT:

P/N 801-01-013 Foundation Tibial Broach to be 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. Recall # Z-0349-2012

MANUFACTURER:Recalling Firm: Encore Medical, LP, Austin, TX, by letter dated October 26, 2011.Manufacturer: Encore Medical, LP, Austin, TX. Firm initiated recall is ongoing.

REASON:The strike plate may dislodge from the broach stem handle during impaction of the device.

PRODUCT:

SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of viewing and printing data stored in SCC product databases. Recall # Z-0362-2012

MANUFACTURER:SCC Soft Computer, Clearwater, FL, by letter dated October 25, 2011. Firm initiated recall is ongoing.    

REASON:When SoftReports Designer opened a layout, the system did not load the layout with the previously saved value in the NewPage property. This caused multiple patient records to be printed on the same page.

PRODUCT

1) VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Kit 45CM Internal Sheath, Catalog No./REF 11402001, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0400-2012; 2) VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Kit 65CM Internal Sheath, Catalog No./REF 11402002, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0401-2012;3) VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch 45cm Kit w/Gripper and RFID T, Catalog No./REF 11403001, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0402-2012;4) VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch 65cm Kit w/Gripper and RFID T, Catalog No./REF 11403002, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0403-2012;5) VenaCure EVLT NeverTouch - FRS .018" System PROCEDURE KIT Featuring Gold-Tipped Fiber, 25 cm, VC EVLT NeverTouch-FRS 0.18 25 cm Kit, Catalog No./REF 11403003, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0404-2012;6) VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 90 cm, VC EVLT NeverTouch-FRS 90cm Kit, Catalog No./REF 11403004, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0405-2012;7) VenaCure EVLT NeverTouch - FRS w/19Ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NT FRS 45cm Kit w/19Ga Needle, Catalog No./REF 11403005, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0406-2012;8) VenaCure EVLT NeverTouch - FRS w/19Ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NT FRS 65cm Kit w/19Ga Needle, Catalog No./REF 11403006, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0407-2012;9) VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, 45cm NeverTouch FRS .018 Procedure Kit, Catalog No/REF 11403012, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0408-2012;10) VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, 65cm NeverTouch FRS .018 Procedure Kit, Catalog No./REF 11403013, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0409-2012;11) VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Procedure Kit 45cm, Catalog No./REF 51402007, STERILE. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0410-2012;12) VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Procedure Kit 65cm, Catalog No./REF 51402008, STERILE. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0411-2012;13) VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, VenaCure NeverTouch FRS 45cm Clear Needle, Catalog No./REF 51403001, STERILE. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0412-2012;14) VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VenaCure NeverTouch FRS 65cm Clear Needle, Catalog No./REF 51403002, STERILE. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0413-2012;15) VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VC NT FRS 65cm Clear Non-Echo Needle, Catalog No./REF 51403005, STERILE. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0414-2012

MANUFACTURER:Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letters dated November 10, 2011.Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.

REASON:During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path.

PRODUCT:

MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle. a) Model # VAR-031-35-10, Model # VAR-031-35-12, Model # VAR-031-35-14, Model # VAR-031-35-16, Model # VAR-031-35-18, Model # VAR-031-35-20, Model # VAR-031-35-22, Model # VAR-031-35-24, Model #, VAR-031-35-26, Model # VAR-031-35-28, Model # VAR-031-35-30 &, b) Model #, MXL-032-35 and Model # VAR-032-35. Recall # Z-0421-2012

MANUFACTURER:Orthohelix Surgical Designs Inc., Medina, OH, by letter dated August 22, 2011. Firm initiated recall is ongoing.

REASON:The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing.

PRODUCT:1) HOTLlNE Disposable Administration Sets, Product Codes L-70 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr. Recall # Z-0422-2012;2) HOTLlNE Disposable Administration Sets, Product Codes L-70NI Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr. Recall # Z-0423-2012;3) HOTLlNE Disposable Administration Sets, Product Code L-270 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr. Recall # Z-0424-2012;4) HOTLlNE Disposable Administration Sets, Product Code L-370 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr. Recall # Z-0425-2012;5) HOTLlNE Disposable Administration Sets, Product Code L-80 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr. Recall # Z-0426-2012;6) Level 1 Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1® Fast Flow Fluid Warmers (H1000, H-1025, H-1028, and H-1200), for the warming and delivery of blood and I.V. solutions, at flow rates of 75ml/min - 530 ml/min. Recall #Z-0427-2012;7) Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1® Fast Flow Fluid Warmers (H1000, H-1025, H-1028, and H-1200), for the warming and delivery of blood and I.V. solutions, at flow rates of 75ml/min - 530 ml/min. Recall # Z-0428-2012

MANUFACTURER:Smiths Medical ASD, Inc., Rockland, MA, by letter dated November 28, 2011. Firm initiated recall is ongoing.

REASON:Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets.

PRODUCT:

UniCel DxC and Synchron LX Clinical Systems 100 L Sample Syringe, 100UL-PKGD, Part Number 474171 Product Usage: The UniCel DxC and LX 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-0452-2012

MANUFACTURER:Beckman Coulter Inc., Brea, CA, by letter beginning September 2, 2010.  Firm Initiated recall is ongoing.

REASON:The Modular Chemistry (MC) and Cartridge Chemistry (CC) 100 uL sample syringes may experience premature wear as indicated by brown discoloration on the plunger and/or inside the glass syringe barrel. Excessive wear of the 100 uL sample syringe barrel and plunger could lead to leaking and may affect results.

PRODUCT:

Artiste Maverick Tint, Part Number: N36TB, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Recall # Z-0455-2012

MANUFACTURER:Recalling Firm: Kerr Corp., Orange, CA, by letter on March 3, 2011.Manufacturer: Pentron Clinical Dental Material, Villa Park, CA. Firm initiated recall is complete.

REASON:The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product.

PRODUCT:

  SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections and is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Recall # Z-0461-2012

MANUFACTURER:Life Technologies Corp., Frederick, MD, by letter dated November 14, 2011. Firm initiated recall is ongoing.

REASON:In vitro diagnostic reagent may be contaminated with a fungal contaminant.

PRODUCT:

SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. Product Usage: 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-0488-2012

MANUFACTURER:SCC Soft Computer, Clearwater, FL, by letter on May 3, 2011. FDA initiated recall is ongoing.

REASON:A client reported that results were not flagged correctly. This can occur when a test is ordered in Order Entry, then collected, received, and resulted from the Order Entry results tab in the same session in Order Entry, within a very short time frame. The patient results are accurate, but if the result interpretation flags are missing, an abnormal test result could be overlooked by a physician when reviewing the patient report. Also, if the abnormal flags are missing, the results will not qualify to the Call list.

PRODUCT:

Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea, mixed apnea or hypopnea, in order to evaluate the necessity for a polysomonographic examination. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. Recall # Z-0520-2012

MANUFACTURER:Del Mar Reynolds Medical, Ltd., Hertford, UK, by letter dated November 11, 2011. Firm initiated recall is ongoing.

REASON:When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System, customers can get corruption in the data or a wrong ECG after the first 32 hours. Both recordings have to be longer than 32 hours for this to happen.

PRODUCT:

Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug 8-methoxypsoralen (8-MOP) of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestation of cutaneous T-cell lymphoma (CTCL) in person who have not been responsive to other forms of treatment. The Cellex procedural kits are designed to interface with the Cellex Photopheresis System to perform cell separation and photo activation in a single closed and sterile circuit. This is accomplished by use of an integrated centrifuge bowl and associated tubing for separation of whole blood into red blood cells, plasma, and buffy coat (leukocyte-enriched blood). All blood components are returned to the patient. The procedural kits are fully assembled as received by the customer and the customer is only required to place the components in the Cellex System to enable the system for use. Recall # Z-0595-2012

MANUFACTURER:Therakos, Inc., Raritan, NJ, by letter dated September 1, 2011. Firm initiated recall is ongoing.

REASON:There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System.

PRODUCT:

Midmark M11 Ultra Steam Sterilizer. Sterilize reusable equipment that is heat and moisture stable. Model #'s: M11-001, M11D-001, M11-001R, M11D-002, M11-002, M11-002R, M11-003, M11-004, M-005, and M11-006. Recall # Z-0597-2012

MANUFACTURER:Midmark Corp., Versailles, OH, by letters the week of January 9, 2012. FDA Initiated recall is ongoing.

REASON:During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning.

PRODUCT:

1) OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor Intended for rotator cuff repair in the shoulder. Recall # Z-0608-2012;2) OPUS Magnum 2 Plus Implant Product Number OM-9026 is one of two kits Intended for rotator cuff repair. Recall # Z-0609-2012;3) OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number OM-1502 Intended for rotator cuff repair.  Recall # Z-0610-2012;4) OPUS SpeedStitch Product Number OM-8086 is a suture cartridge. For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. Recall # Z-0611-2012;5) OPUS SmartStitch Product Number OM-8178 is a suture cartridge; for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. Recall # Z-0612-2012;6) OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer. Recall # Z-0613-2012;7) OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor intended to be used for fixation of soft tissue to bone. Recall # Z-0614-2012;8) 3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand.Recall # Z-0615-2012;9) SideWinder Hip Wand Product Number AC2340-01 is an ablation wand intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0616-2012;10) MultiVac Tristar 50 Product Number AS4630-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0617-2012;11) CoVac 50 Product Number AS2530-01 is an ablation wand intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0618-2012;12) CoVac 70 Product Number AS3730-01 is an ablation wand intended for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in arthroscopic procedures. Recall # Z-0619-2012;13) 3.0mm 45 Degree bevel Part Number A2430-01 is an ablation wand intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0620-2012;14) 3.5mm 90 Degree Part Number A1335-01 is an ablation wand intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0621-201215) Saber 30 Part Number A4330-01 is an ablation wand Indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0622-2012;16) Turbo Vac 90 with Cable Part Number ASC1335-01 is an ablation wand Indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall #Z-0623-2012;17) Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand. Recall # Z-0624-2012;18) 90 Degree LoPro with Cable Part Number AC1336-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0625-2012;19) 3.0 60 Degree wand Part Number A2530-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels. Recall # Z-0626-2012;20) 5.0 mm Parafix Part Number 22-5011 is a suture anchor metal Intended for rotator cuff repair. Recall # Z-0627-2012;21) OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair. Recall # Z-0628-2012

MANUFACTURER:Recalling Firm: Innovatech Medical Resources L.P., Midlothian, TX, by visit beginning August 8, 2011.Manufacturer: ArthroCare Corp., Sunnyvale, CA. Firm initiated recall is ongoing.

REASON:Product is being removed from the field due to an over-label issue.

PRODUCT:

Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900. Product Usage: The OCTOPUS 900 Perimeter is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye. Recall # Z-0638-2012

MANUFACTURER:Recalling Firm: Haag-Streit USA Inc., Mason, OH, by letter dated November 11, 2011.Manufacturer: Haag Streit Ag, Koeniz, Switzerland. Firm initiated recall is ongoing.

REASON:Currently there is a possibility, at the start of the perimetry examination, for the background illumination of the cupola not to turn on. If no illumination of cupola occurs, data obtained from the examination could provide the doctor with results that would appear to be better than actual.

PRODUCT:

1) Dimension(R) Vista(R) V-LYTE(R) Standard A (K820) Product Usage: V-LYTE(R) Standard A is for the calibration of NA, K, and CL on the Dimension Vista(R) system.Recall # Z-0644-2012;2) Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt Bridge (K825) Product Usage: V-LYTE(R) Standard B/Salt Bridge is for the calibration and measurement of NA, K, and CL on the Dimension Vista(R) system. Recall # Z-0645-2012;3) Dimension(R) Vista(R) V-LYTE(R) Diluent (K835) Product Usage: V-LYTE(R) Diluent is for the automatic dilution of samples processed in the V-LYTE(R) Integrated Multisensor on the Dimension Vista(R) system. Recall # Z-0646-2012

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

REASON:: Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new IMT sensor. The results can be elevated approximately 10-20% which may cause QC recovery being out of acceptable ranges. Patient Urine sodium results may also be significantly affected. Serum sodium QC may show an upward trend of up to 6 mmol/L for the serum QC.

PRODUCT:

Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic manual surgical instrument is a non powered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. Model number 03.010.228. Recall # Z-0676-2012

MANUFACTURER:Synthes USA (HQ), Inc., West Chester, PA, by letters on November 2, 2011. Firm initiated recall is ongoing.

REASON:Synthes is initiating a recall of the Drill Bit for 5.0mm Recon Screws with large Quick Coupling due to the potential for the drill stop to slip on the drill bit.

CLASS III

PRODUCT:

Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. The Step 2, 3000-2000 GPD chemical is used in the cleaning procedures for the Isopure MD400 Series Reverse Osmosis System. Recall # Z-0190-2012

MANUFACTURER:Recalling Firm: Isopure Corp., Simpsonville, KY, by letter dated October 24, 2011.  Manufacturer: Di-Chem Inc., Champlin, MN. Firm initiated recall is ongoing.  

REASON:The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl).

PRODUCT:

TUM-E-VAC Ethox International. Intended use: gastric lavage. Recall # Z-0271-2012

MANUFACTURER:Ethox International, Inc., Buffalo, NY, by letter dated March 25, 2011. Firm initiated recall is ongoing.

REASON:Ethox Tum-E-Vac Gastric Lavage Kit #2075 is labeled with expiration date symbol and date of 2010/10 on the unit product label. The carton is labeled with a manufacturing date symbol and date of 2010/10. The Ethox Tum-E-Vac Gastric Lavage Kit #2075 does not have an expiration date.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 4, 2012.

CLASS I

PRODUCT:

INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. Recall # Z-0583-2012

MANUFACTURER:Ino Therapeutics. Madison WI, by letter dated December 22, 2011. Firm initiated recall is ongoing.

REASON:Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR & 806.10.

CLASS II

PRODUCT:

Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand, a sealed source calibration certificate (100% assay report), a radiograph of the loaded needles in the needle-holding card, and a source certification technical data sheet.; Products Provided by: Oncura, Prescription Filled by: AnazaoHealth,; product identifier: I125RSRX, model 7000. RA PID Strand Rx is indicated for permanent interstitial implantation of selected localized tumors that are of low to moderate radio sensitivity. It may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for the treatment of residual disease after excision of the primary tumor. RAPID Strand Rx may be indicated for use concurrent with or at the completion of other treatment modalities such as external beam radiation therapy. Recall # Z-0266-2012

MANUFACTURER:  Medi-Physics Inc. dba GE Healthcare, Arlington Heights, IL, by letter dated September 20, 2011. Firm initiated recall is ongoing.

REASON:  There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy.

PRODUCT:

Suction Handle (Sterile) Part Number: 1990S. For use in open heart procedures, Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems. Recall # Z-0273-2012

MANUFACTURER:  International Biophysics Corp., Austin, TX, by letter dated October 5, 2011. Firm initiated recall is ongoing.

REASON:  Potential for the sterility to be compromised.

PRODUCT:

cobas c 311 Analyzer, Part Number: 04826876001 In-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. Recall # Z-0310-2012

MANUFACTURER:  Recalling Firm: Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter on October 26, 2011.Manufacturer: MHitachi High-Technologies Corp., Tokyo, Japan. Firm initiated recall is ongoing.

REASON:  The cobas c 311 analyzer software may incorrectly calculate the volume of the ISE Reference Electrolyte solution remaining on the analyzer. In some cases the incorrect results obtained will not be flagged with any data alarms.

PRODUCT:

SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. SoftMic is a laboratory information system to be used in medical research, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data. Recall # Z-0466-2012

MANUFACTURER:  SCC Soft Computer, Clearwater, FL, by a Field Correction dated August 25, 2011. Firm initiated recall is ongoing.

REASON:  When a certain series of keystrokes on the test grid are performed while entering results and statusing a test, the test status may not be maintained upon saving. The status may be removed or copied from another test on the order upon saving.

PRODUCT:

Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678), in vitro diagnostic. Recall # Z-0513-2012

MANUFACTURER:  Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter on November 17, 2011. Firm initiated recall is ongoing.

REASON:  Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients.

PRODUCT:

Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161. Recall # Z-0598-2012

MANUFACTURER:  Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by visit on May 9, 2011.Manufacturer: Baxter Healthcare SA, Singapore, Singapore. Firm initiated recall is complete.

REASON:  There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.

PRODUCT:

1) Coulter LH500 Series Analyzer, Part number: 178832, 178833, 178834. LH 500 Series System Instructions for Use, PN 624602 Rev BA. 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. Recall # Z-0599-2012;2) Coulter HmX Hematology Analyzer, Part number: 6605522, 6605523, 6605524. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. Recall # Z-0600-2012;3) Coulter HmX Hematology Analyzer with Autoloader, Part number: 6605525, 6605526, 6605527. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. Recall # Z-0601-2012;4) COULTER MAXM Hematology Analyzer/MAXM Hematology Analyzer with Autoloader Part number: 6705995, 6705996, 6705997/ Part number: 6705998, 67059999, 6706000. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. Recall # Z-0602-2012

MANUFACTURER:  Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 13, 2011. Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

REASON:  The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.

PRODUCT:

The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Recall # Z-0603-2012

MANUFACTURER:  Recalling Firm: PerkinElmer LAS, Inc., Waltham, MA, by letters on October 24, 2011.   Manufacturer: PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, Finland. Firm initiated recall is ongoing.

REASON:  Malfunction of the GSP disk remover unit may cause a punched disc to remain in the well during the measurement of the plate. This may cause a false negative screening result being reported for 17-OHP, resulting in failure to identify cases of congenital adrenal hyperplasia (CAH).

PRODUCT:

CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels is needed. Recall # Z-0604-2012

MANUFACTURER:  Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated December 4, 2011. FDA initiated recall is ongoing.

REASON:  Terumo is recalling the CDI 101 Hematocrit/Oxygen Saturation Monitoring System because they have not yet submitted a 510(k) to FDA to market the device.

CLASS III

PRODUCT:

Curix Opthos H, size 35x43 cm A radiographic medical x-ray film designed to optimize diagnostic chest imaging by providing complete diagnostic information including superbly visualized lung detail along with a high level of retro-cardiac, sub-diaphragmatic and mediastinal information. Recall # Z-0285-2012

MANUFACTURER:  Recalling Firm: AGFA Corp., Greenville, SC, by letter on October 7, 2011.Manufacturer: Agfa Materials Corp., Goose Creek, SC. Firm initiated recall is ongoing.

REASON:  The film notch was located in the wrong position.

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.

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