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FDA Recalls

January 1, 2007 -  June 30, 2007

• Recalls as of June 27, 2007
• Recalls as of June 20, 2007
• Recalls as of June 13, 2007
• Recalls as of June 6,  2007
• Recalls as of May 30, 2007
• Recalls as of May 23, 2007
• Recalls as of May 16, 2007
• Recalls as of May 9, 2007
• Recalls as of May 2, 2007
• Recalls as of April 25, 2007
• Recalls as of April 18, 2007
• Recalls as of April 11, 2007
• Recalls as of April 4, 2007
• Recalls as of March 28, 2007
• Recalls as of March 21, 2007
• Recalls as of March 14, 2007
• Recalls as of March 7, 2007
• Recalls as of February 28, 2007
• Recalls as of February 21, 2007
• Recalls as of February 14, 2007
• Recalls as of February 7, 2007
• Recalls as of January 31, 2007
• Recalls as of January 24, 2007
• Recalls as of January 17, 2007
• Recalls as of January 10, 2007
• Recalls as of January 3, 2007

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 27, 2007
CLASS II
MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on March 2, 2007. Firm initiated recall is ongoing CLASS II
PRODUCT:
a) LIFEPAK CR Plus defibrillator, Recall # Z-0836-2007;
b) LIFEPAK EXPRESS defibrillator, Recall # Z-0837-2007.
REASON: Premature battery depletion due to electrical component failure.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letters on April 30, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; Recall # Z-0950-2007;
b) ARCHITECT i2000sr Processing Module, for in vitro diagnostics; List Number: 3M74-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; Recall # Z-0951-2007;
c) ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number: 1G06-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; Recall # Z-0952-2007;
d) ARCHITECT c16000 Processing Module, for in vitro diagnostics; List Number: 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; Recall # Z-0953-2007

REASON: One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring a standard sample dilution. 3) Infrequent data may be missing from automatically or manually printed reports generated on the Architect system. 4) Clinical Chemistry Assays using the Spline Math Model may be unflagged but decreased (affects both Abbott and open system assays for Architect c System).

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, letter dated May 14, 2007. Manufacturer: Roche Diagnostics GmbH, Penzberg, Germany. Firm initiated recall is ongoing.
PRODUCT: MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001, Recall # Z-0956-2007.
REASON: False Positive Results: Product labeling states cross contamination is not an issue for high viral load titer samples, but the firm has determined that a potential sample contamination may not be detected at these levels and could result in false positive results being reported.

MANUFACTURER: Steris Corp., Mentor, OH, by telephone beginning February 22, 2007 and by letters dated February 23, 2007. Firm initiated recall is ongoing
PRODUCT: Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used to process the Fujinon 250/270/450/470/490 Group 5 and 530/590 series GI Endoscopes w/o Water Jet. The QFC1729 is used to process 250/450 Group 5 and 530/590 series Endoscopes w/ Water Jet, Recall # Z-0967-2007.
REASON: The center insert of the adaptor #6 restrictor could become loose and/or come out of the housing and may affect the sterilization process of the attached endoscope.

CLASS III
MANUFACTURER: Possis Medical, Inc., Minneapolis, MN, by letter on May 1, 2007. Firm initiated recall is ongoing
PRODUCT:
a) Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, (Spiroflex Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System); Part number: 105835-001, Recall # Z-0954-2007;
b) Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxide, (XMI - Rapid Exchange Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System). Part number: 104504-001, Recall # Z-0955-2007
REASON: Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.

MANUFACTURER: Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letter on May 1, 2007. Manufacturer: Becton Dickinson Vacutainer Micrope, San Lorenzo, PR. Firm initiated recall is ongoing.
PRODUCT: BD Microtainer Tube Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Recall # Z-0957-2007
REASON: Mislabeling. Box and bag labels are incorrectly labeled to indicate the product contains Sodium Fluoride/Potassium Oxalate, however the instructions for use and the product itself are correct in the additive indicated and used (Sodium Fluoride/Na2EDTA).

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 20, 2007

CLASS I
MANUFACTURER: Recalling Firm: Abbott Laboratories MPG, Abbott Park, IL, by letter on March 8, 2007, press release on May 25, 2007 and by follow-up letter on May 29, 2007. Manufacturer: Fisher Diagnostics, A Company of Fisher Scientific LLC, Middletown VA. Firm initiated recall is ongoing.
PRODUCT: ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent, Recall # Z-0855-2007
REASON: False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might not be met for all lots of Architect STAT Troponin-I reagents, thus false negative results may occur with negative results less than 0.1 ng/mL

CLASS II
MANUFACTURER: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on March 20, 2007. Firm initiated recall is ongoing.
PRODUCT: Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 83501. Product is a Collimator/ Beam Limiting Device and are replacement components for the Bucky Diagnost TH X-ray system, Recall # Z-0739-2007.
REASON: The Collimator field-defining light beam does not meet the light field contrast ratio requirement of 4:1. System is non-compliant with performance standard 21 CFR 1020.31 (d)(2)(iii)

MANUFACTURER: General Electric Medical Systems Information Technology, Milwaukee, WI, by letter on March 13, 2007. Firm initiated recall is ongoing.
PRODUCT: GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (System hardware consists of a processing unit and a monitor), Patient Monitor, Recall # Z-0891-2007.
REASON: Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when used with Telemetry. Each issue occurs in software version v4.1 only; A) the system may experience a loss of audible alarms when operating system memory resources reach 170MB and/or B) the system may intentionally or unexpectedly reboot

MANUFACTURER: Integrated Measurement Systems, Inc., Elk Grove Village, IL, by telephone on January 30, 2007. Firm initiated recall is ongoing.
PRODUCT: IMS Patient Scale used on Sunrise Medical’s Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4PT-WSC and HOY- STATUREWSC, Recall # Z-0921-2007
REASON: Patient Scale may become detached, which can cause a patient to fall and result in injury.

MANUFACTURER: Biomet 3i, Palm Beach Gardens, FL, by e-mail on October 16, 2006, by telephone and letter on October 19, 2006. Firm initiated recall is ongoing
PRODUCT: EP Healing abutment. Product Code-ITHA52. A pre-manufactured prosthetic component directly connected to an endosseous dental implant, Recall # Z-0922-2007.
REASON: Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.

MANUFACTURER: Recalling Firm: St Jude Medical CRMD, Sylmar, CA, by letter on March 20, 2007. Manufacturer: Oscor, Inc., Palm Harbor, FL. Firm initiated recall is ongoing.
PRODUCT: St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126, Recall # Z-0933-2007.
REASON: Device Separation. Product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.

MANUFACTURER: Recalling Firm: Medtronic Neurological, Minneapolis, MN, by telephone and field representative visit in April 2007.
Manufacturer: Medtronic Puerto Rico Inc., Villalba Pr, PR. Firm initiated recall is ongoing.
PRODUCT: Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Recall # Z-0934-2007
REASON: The inner package labeling incorrectly specified the model number of the lead as 3387-40. The outer package labeling is correct and the package actually contains the correct lead (3389S-40).

MANUFACTURER: Porous Media Corporation, Saint Paul, MN, by letter dated April 26, 2007. Firm initiated recall is ongoing
PRODUCT: HUMIDIFLOW Respiratory Gas Humidifier; Part Number/Model # HMK-RM, Recall # Z-0935-2007.
REASON: The Intake filter of the Humidiflow kits may became detached from the module and fall onto the compressor cooling fan during patient treatment. (If the filter were to come in contact with the fan blades this could stop the fan from operating and cause the concentrator to overheat and interrupt the flow of oxygen to the patient).

MANUFACTURER: Zoll Lifecor Corporation, Pittsburgh, PA, by letter on May 3, 2007. Firm initiated recall is ongoing.
PRODUCT: Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt, Recall # Z-0936-2007.
REASON: The electrodes do not properly release conductive gel

MANUFACTURER: Recalling Firm: Conmed Endoscopic Technologies, Inc., Billerica, MA, by letters on April 16, 2007 and April 17, 2007. Manufacturer: Servicios Ensamble Internacionales, Ciudad Juarez, Mexico. Firm initiated recall is ongoing.
PRODUCT:
a) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 8cm; product code/end item #000341; Single Use, Non-Sterile; Recall # Z-0937-2007;
b) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 8cm; product code/end item #000342; Single Use, Non-Sterile; Recall # Z-0938-2007;
c) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 8cm; product code/end item #000343 and #000443 (5 pack); Single Use, Non-Sterile; Recall # Z-0939-2007;
d) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 8cm; product code/end item #000344 and #000735 (5 pack); Single Use, Non-Sterile; Recall # Z-0940-2007;
e) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD)size 18mm (54 Fr), length 8cm; product code/end item #000345 and #000736 5 pack); Single Use, Non-Sterile; Recall # Z-0941-2007;
f) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 8cm; product code/end item #000380 and #000379 (5 pack); Single Use, Non-Sterile; Recall # Z-0942-2007;
g) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18 Fr), length 4cm; product code/end item #000844; Single Use, Non-Sterile; Recall # Z-0943-2007;
h) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD)size 8mm (24 Fr), length 4cm; product code/end item #000845; Single Use, Non-Sterile; Recall # Z-0944-2007;
i) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 4cm; product code/end item #000846; Single Use, Non-Sterile; Recall # Z-0945-2007;
j) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 4cm; product code/end item #000847 and #000857 (5 pack); Single Use, Non-Sterile; Recall # Z-0946-2007;
k) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 4cm; product code/end item #000848 and #000858 (5 pack); Single Use, Non-Sterile; Recall # Z-0947-2007;
l) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 4cm; product code/end item #000849 and #000859 (5 pack); Single Use, Non-Sterile; Recall # Z-0948-2007;
m) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 4cm; product code/end item #000861 and #000867 (5 pack); Single Use, Non-Sterile; Recall # Z-0949-2007
REASON: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.

MANUFACTURER: Biomet 3i, Palm Beach Gardens, FL, by telephone, email and letter beginning on May 14, 2007. Firm initiated recall is ongoing.
PRODUCT: Biomet 3i, disposable twist drills, Model number DT2715, Recall # Z-0959-2007.
REASON: The depth indicator laser line markings on the drills are too faint for clinicians to read during use.

MANUFACTURER: Synovis Surgical Inovation, Saint Paul, MN, by letters on March 16, 2007, April 23, 2007 and May 5, 2007. Firm initiated recall is ongoing.PRODUCT:
a) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 21-E-V), 21mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip, Recall # Z-0960-2007;
b) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 25-E-V), 25mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip, Recall # Z-0961-2007;
c) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 29-E-V), 29 mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip, Recall # Z-0962-2007;
d) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 21-U-V), 21mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip, Recall # Z-0963-2007;
e) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 25-U-V), 25 mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip, Recall # Z-0964-2007;
f) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,
(PSD 28-U-V), 28mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip, Recall # Z-0965-2007
REASON: Package Integrity/Sterility Compromised: The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 13, 2007:

CLASS II
MANUFACTURER: EV3 Neurovascular, Irvine, CA, by letter on April 5, 2007. Firm initiated recall is ongoing.
PRODUCT: Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200, Recall # Z-0839-2007
REASON: Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures.

MANUFACTURER: Recalling Firm: Smith & Nephew, Inc., Endoscopy Division, Oklahoma City, OK, by letter on April 9, 2007. Manufacturer: Sopro, La Ciotat Cedex, France. Firm initiated recalls ongoing.
PRODUCT: Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510, Recall # Z-0840-2007
REASON: Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail causing the light to cease operating. The problem can occur anytime: from the initial turning on (powering up), to anytime during use.

MANUFACTURER: CryoLife, Inc., Kennesaw, GA, by telephone on April 17 and 18, 2007. Firm initiated recall is complete.
PRODUCT: a) CryoValve, Pulmonary Valve & Conduit; Donor number 87980,
Model Number PV00, Recall # Z-0841-2007; b) Aortic Valve & Conduit; Donor number 87980, Model Number AV00, Recall # Z-0842-2007
REASON: Donor tissue was released prior to information received regarding a pericardial effusion.

MANUFACTURER: Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated March 23, 2007. Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing.
PRODUCT:
a) Infant Nasal CPAP Cannula, Size 0; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Made in Mexico; The cannulas are sold as components in the following configurations: a) catalog No. 1690 and 41690 (International): Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape; b) catalog No. 1683: Infant CPAP System intended for use with a water seal or spring loaded valve, and includes one cannula with one inspiratory and one expiratory elbow connector, two 4 ft. lengths of 10mm I.D. corrugated tubing, one 4 ft. pressure monitoring line, one 22mm to 10mm humidifier adapter, one knit cap and two 6 inch sections of Velcro securing tape, Recall # Z-0857-2007;
b) Infant Nasal CPAP Cannula, Size 1; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Made in Mexico; The cannulas are sold as components in the following configurations: a) catalog No. 1691and 41691 (International): Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape; b) catalog No. 1685: Infant CPAP System intended for use with a water seal or spring loaded valve, and includes one cannula with one inspiratory and one expiratory elbow connector, two 4 ft. lengths of 10mm I.D. corrugated tubing, one 4 ft. pressure monitoring line, one 22mm to 10mm humidifier adapter, one knit cap and two 6 inch sections of Velcro securing tape, Recall # Z-0858-2007;
c) Infant Nasal CPAP Cannula, Size 2; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Made in Mexico; The cannulas are sold as components in the following configurations: a) catalog No. 1692: Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape; b) catalog No. 1686: Infant CPAP System intended for use with a water seal or spring loaded valve, and includes one cannula with one inspiratory and one expiratory elbow connector, two 4 ft. lengths of 10mm I.D. corrugated tubing, one 4 ft. pressure monitoring line, one 22mm to 10mm humidifier adapter, one knit cap and two 6 inch sections of Velcro securing tape; Recall # Z-0859-2007
d) Infant Nasal CPAP Cannula, Size 3; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Made in Mexico; The cannulas are sold as components in the following configuration: catalog No. 1693: Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape, Recall # Z-0860-2007;
e) Infant Nasal CPAP Cannula, Size 4; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Made in Mexico. The cannulas are sold as components in the following configuration: catalog No. 1694: Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape; Recall # Z-0861-2007
REASON: The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.

MANUFACTURER: Recalling Firm: Smith & Nephew Inc., Memphis, TN, by letter on March 13, 2007. Manufacturer: Smith & Nephew Orthopedics, Warwick, UK. Firm initiated recall is ongoing.
PRODUCT:
a) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146, Recall # Z-0862-2007;
b) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 50 mm cup Ref.: 74120150, Recall # Z-0863-2007;
c) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156, Recall # Z-0864-2007;d) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 58 mm cup Ref.: 74120158, Recall # Z-0865-2007;
e) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 60 mm cup Ref.: 74120160, Recall # Z-0866-2007
REASON: The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.

MANUFACTURER: Recalling Firm: Wright Medical Technology Inc., Arlington, TN, by letter dated March 27, 2007. Manufacturer: Wright Cremascoli Ortho SA, Toulon, France. Firm initiated recall is ongoing.
PRODUCT:
a) Profemur® R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only Hip implant, Recall # Z-0867-2007;
b) Profemur® R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only. Hip implant, Recall # Z-0868-2007
REASON: The titanium plasma coating was found to have missing fragments.

MANUFACTURER: Recalling Firm: Vision Systems Group, A Div of Viking Systems, Westborough, MA, by telephone on March 15, 2007. Manufacturer: Luxtec Corporation, A Division of LXU Healthcare I, West Boylston, MA. Firm initiated recall is complete.
PRODUCT: Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190), Recall # Z-0873-2007
REASON: Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure.

MANUFACTURER: Surge Medical Solutions, LLC, Grand Rapids, MI, by letter dated April 17, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm,
guidewire stylet, sterile, REF CODE: RSG-M014S, Recall # Z-0892-2007;
b) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm,
guidewire stylet, 12.5' (31.8cm), sterile, REF CODE: RSG-M014S-L, Recall # Z-0893-2007;
c) Surge Medical Solutions Retrograde Cardio. Cannula, 18mm self-inflating textured balloon, 15Fr (5.0mm), guidewire stylet, 12.5'(31.8cm), sterile, REF CODE: RSG-T014S-L, Recall # Z-0894-2007;
d) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 20 mm,
handle stylet, sterile, REF CODE: RSH-L014S, Recall # Z-0895-2007;
e) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm,
handle stylet, sterile, REF CODE: RSH-M014S, Recall # Z-0896-2007;
f) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon,
sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-M014S-L, Recall # Z-0897-2007;
g) Surge Medical Solutions brand 15 Fr. (5.0mm) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 14 mm, handle stylet, sterile, REF CODE: RSH-S014S, Recall # Z-0898-2007;
h) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured balloon
18 mm, handle stylet, sterile, REF CODE: RSH-T014S, Recall # Z-0899-2007;
i) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18mm self-inflating textured
balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-T014S-L,
Recall # Z-0900-2007;
j) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 20 mm,
rigid insertion stylet, sterile, REF CODE: RSR-L014S, Recall # Z-0901-2007;
k) Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon
18 mm, rigid insertion stylet, sterile, REF CODE: RSR-M014S, Recall # Z-0902-2007;
l) Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon
18 mm and rigid stylet, 12.5'(31.8cm), sterile, REF CODE: RSR-M014S-L, Recall # Z-0903-2007;
m) Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured
balloon 18 mm, rigid stylet, sterile, REF CODE: RSR-T014S, Recall # Z-0904-2007
REASON: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.

MANUFACTURER: Recalling Firm: Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on March 14, 2007. Manufacturer: Varian Medical Systems, Inc., Charlottesville, VA. Firm initiated recall is ongoing.
PRODUCT: FramelessArray software, Version 1.0., Recall # Z-0905-2007
REASON: Localization error; with planning data transferred to the Optical Guidance Platform via DICOM RT; The software incorrectly computes the center of the CT volume, resulting in a potential axial error ranging from 0.3 mm to 1.5 mm, affecting both Fractionated and Stereotactic Radiosurgery (SRS) Treatments.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated April 30, 2007. Manufacturer: Danish Diagnostic Dev. A/S, Horsholm, Denmark. Firm initiated recall is ongoing.
PRODUCT: c.cam Gamma Camera, Model 9VIR1200; Made in Denmark, Recall # Z-0906-2007
REASON: Chair Breakage: Under extreme load, the chair back of the c.cam emission computed tomography system may bend and eventually break. This could be caused by the accumulated stress from heavy patients seating or stretching themselves in the chair or simply from long time use.

MANUFACTURER: Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by letter dated February 5, 2007.Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
PRODUCT:
a) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular imaging system.), Recall # Z-0913-2007;
b) GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic Imaging System ( Cardiovascular Imaging System), Recall # Z-0914-2007;
c) GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography System), Recall # Z-0915-2007
REASON: Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new,

MANUFACTURER: Exactech, Inc., Gainesville, FL, by fax and email on July 21, 2006. Firm initiated recall is ongoing.
PRODUCT: AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44, Recall # Z-0916-2007
REASON: The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 5, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No. 04642511190, Recall # Z-0917-2007;
b) Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190, Recall # Z-0918-2007
REASON: Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Online TDM gentamycin, Online TDM phenytoin, Online DAT cocaine II, Online DAT methadone II, Online DAT opiates II and Online DAT THC II.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 30, 2007. Firm initiated recall is ongoing.
PRODUCT: a) Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer;Catalog No.04491050190, Recall # Z-0919-2007;
b) Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer;Catalog No.04491041190, Recall # Z-0920-2007
REASON: Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.

MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letters on April 27, 2007. Firm initiated recall is ongoing.
PRODUCT: LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics. Affected part numbers: 3202487-073 through -083; 3202487-087 through -090; 3202487-092; 3202487-093; 3202487-098; 3202488-036; 3202488-038 through -042; 3202488-045; 3202488-046; and 3202488-050., Recall # Z-0925-2007
REASON: White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.

MANUFACTURER: Recalling Firm: Hawaii Medical LLC, Pembroke, MA, by telephone and follow-up letter on May 15, 2007.Manufacturer: Facet Technologies Llc, Marietta, GA. Firm initiated recall is ongoing.
PRODUCT:
a) NeatNick Sweeping Action Heel Lancet -Full-Term- Item Number: 1030085 (box of 100) and Item Number: 1030086, case of 1,000 (10 boxes of 100), Recall # Z-0926-2007;
b) NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and Item Number: 1030084, case of 1,000 (10 boxes of 100), Recall # Z-0927-2007
REASON: Lancet may misfire and an inadequate blood sample may result; additionally, the blade may not retract after use and result in a needle stick to the user/patient

CLASS III
MANUFACTURER: Recalling Firm: Abbott Diabetes Care, Inc., Alameda, CA, by letters dated March 5, 2007. Manufacturer: Benchmark Electronics (Thailand) PCL, Ayudhaya, Thailand. Firm initiated recall is ongoing.
PRODUCT: Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit. Other Brand names include: Precision Xceed Blood Glucose Monitoring system, Optium Xceed, Omron, HEA-214, Optium Xido, MediSense Optium, Boots, Optium (includes Medline and Liberty), Kroger, ReliOn, Rite Aid, Recall # Z-0856-2007
REASON: The front button covers may detach from the meter.

MANUFACTURER: Recalling Firm: Smith & Nephew, Inc Endoscopy Division, Oklahoma City, OK, by letter and telephone on November 1, 2006. Manufacturer: Allen Medical Systems, Inc., Acton, MA. Firm initiated recall is ongoing.
PRODUCT: Well Leg Holder with Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632, Recall # Z-0872-2007
REASON: The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 6, 2007:

CLASS I
MANUFACTURER: Alcon Refractive Horizons, Inc., Orlando, FL, by letter on May 11, 2007. Firm initiated recall is ongoing.
PRODUCT: LADAR6000 Excimer Laser System, Recall # Z-0854-2007
REASON: Observed 'central islands' in patients following custom myopia laser procedures using the LADAR6000 Excimer Laser.

CLASS II
MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letters on April 20, 2007 Manufacturer: B. Braun Dominican Republic, Inc., Santo Domingo, Dominican Republic. Firm initiated recall is ongoing.
PRODUCT:
a) Ultrasite Horizon Pump IV Set. The product is shipped in cases containing 24 sets, Recall # Z-0818-2007;
b) Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets, Recall # Z-0819-2007
REASON: Secondary infusion backs up into primary container.

MANUFACTURER: Kensey Nash Corp., Exton, PA, by telephone on March 26, 2007, and by fax on March 28, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire).The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX of LFX Catheter, and the AutoStream Flow Control, Recall # Z-0833-2007;
b) FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box, Recall # Z-0834-2007;
c) ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box, Recall # Z-0835-2007
REASON: Insufficient wire sealing

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by e-mails on March 22, 2007/Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
PRODUCT: a) Baxter Colleague Single Channel Volumetric Infusion Pumps; Made in Singapore; product codes 2M8161, 2M8161L, 2M8161R and 2M9161, Recall # Z-0836-2007;b) Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore; product codes 2M8163, 2M8163L, 2M8163R and 2M9163, Recall # Z-0837-2007
REASON: A small number of the pumps may power off with a single key press of the ON/OFF key, and the audible speaker tone at POWER ON may ring out of sequence.

MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by letter on April 17, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Recall # Z-0843-2007;
b) Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid administration sets, 40000, Recall # Z-0844-2007;
c) Custom 72 inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid administration sets, Recall # Z-0845-2007;
d) Custom Kit, Cardiac Cath Kit, Rx only, REF/CAT No.: K09-90240HP, Recall # Z-0846-2007;
e) Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only,
Recall # Z-0847-2007
REASON: Male luer in fluid administration sets may crack due to inadequate molding process.

MANUFACTURER: Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by letter on March 26 & 27, 2007. Manufacturer: GE Medical Systems, SCS, Buc Cedex, Wisconsin, France. Firm initiated recall is ongoing.
PRODUCT:
a) GE Healthcare Innnova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System), Recall # Z-0869-2007;
b) GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System), Recall # Z-0870-2007;
c) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular), Recall # Z-0871-2007
REASON: Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control room) or in-room InnovaCentral/Touch-Screen.

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on April 11, 2007. Manufacturer: Boston Scientific Corporation, Quincy, MA. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110, Recall # Z-0889-2007
REASON: Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box actually contains a Percutaneous Tract Kit with Amplatz Dilator and Sheath Kit

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on May 2, 2007. Manufacturer: Siemens AG MED, Erlangen, Germany. Firm initiated recall is ongoing.
PRODUCT: Sienet MagicStore. Radiological Digital Image Communications System. Model number 7502052, Recall # Z-0890-2007
REASON: System could crash and result in data loss.

The following is a condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 30, 2007

CLASS I

MANUFACTURER: Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY, by telephone, fax, letter and e-mail on April 27, 2007 and by nationwide press release on May 4, 2007. Manufacturer: Ortho-Clinical Diagnostics, Cardiff, United Kingdom. Firm initiated recall is ongoing.

PRODUCT: VITROS® Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD, Recall # Z-0820-2007

REASON: Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.

MANUFACTURER : Recalling Firm: Integra LifeSciences Corp, Plainsboro, NJ,

Manufacturer: Shelhigh, Inc, Union, NJ. Firm initiated recall is ongoing.

PRODUCT:
a) Endura No-React Dural Substitute 2 cm x 10 cm, Product code: ENR20210; Recall # Z-0827-2007;
b) EnDura No-React Dural Substitute 4 cm X 10 cm, Product code: ENR20404, Recall # Z-0828-2007;
c) EnDura No-React Dural Substitute 5 cm x 6 cm, Product code ENR20506, Recall # Z-0829-2007;
d) Endura No-React Dural Substitute 6 cm x 10 cm, Product code: ENR20610, Recall # Z-0830-2007;
e) EnDura No React Dural Substitute 10 cm x 12 cm; Product code: ENR21012, Recall # Z-0831-2007;
f) EnDura No-React Dural Substitute 12 cm Diameter, Product code: ENR21212, Recall # Z-0832-2007

REASON: Product is being recalled based on an FDA Public Health Notification and FDA requested recall letter to Shelhigh citing sterility and other manufacturing concerns.

CLASS II

MANUFACTURER: Recalling Firm: Abbott Diabetes Care, Inc, Alameda, CA, by letter on December 21, 2006. Manufacturer: Lahlouh, Burlingame, CA. Recall initiated recall is ongoing.

PRODUCT: Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4),(Version 2.5), and (Version 2.6); Part Numbers: 99040-01, 99063-02.99514-01,97444-04, 97444-05,97445-05,97570-04, 98891-04,98929-05,98931-04, 98889-06, 98890-05, 98891-05, 98929-06,98931-05,99063-04, 99516-03, 80378-01,80379-01,80380-01, 80381-01, 80382-01,80383-01, 80392-01, 70519-01, 80392-02, Recall # Z-0709-2007

REASON: If the time and date are not set correctly on both the user's meter and computer, there is the potential for incorrect times and dates to be assigned to the results in the Precision Link Software.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letters on March 28, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01, Recall # Z-0790-2007;
b) ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01, Recall # Z-0791-2007;
c) ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test kits), 07K60-25 (100 test kits) and 07K60-30 (4 x 500 test kits)

REASON: If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.

MANUFACTURER: C P Medical, Portland, OR, by telephone on April 3, 2007, by follow-up letter dated April 9, 2007, April 17 and April 18, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) Polyester braided and coated nonabsorbable surgical suture with double needle,size 2/0 (3.0 Metric), NSH 26 mm TAPER Needle. Product overwrap label includes: '2/0 (3.0 metric) CP523A Polybond Green Braided, Polyester Coated Nonabsorbable Sterile Suture Rx Only TAPER NSH 36' (90cm) 1/2 26mm. Product box label includes: '2/0 (3.0 metric) CP523A NSH 26 mm 1/2 TAPER POLYBOND Green Polyester Braided Coated Nonabsorbable 36' (90cm), Recall # Z-0807-2007;
b) Blue Polypropylene monofilament synthetic nonabsorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Box Label includes: '3/0 (2.0 metric) POLYPRO Blue Monofilament Polypropylene Nonabsorbable Suture 8665P Rx Only NFS-2 19 mm 3/8 CUTTING 18' (45 cm) One Dozen Sterile. Side of box has an adhesive sticker label which includes: 'Vet Use Only'. Packet Label includes: '3/0 (2.0 metric) 8665 NFS-2 19mm 3/8 TAPER POLYPROPYLENE Blue Polypropylene Monofilament Synthetic Nonabsorbable Suture 18' (45 cm) STERILE EO. Product is also distributed under two private labels, Webster Veterinary and Butler. Webster Veterinary Box Label includes:'3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene NonabsorbableSuture Distributed by: WEBSTER VETERINARY One Dozen Sterile 07-836-4643(8665P) 26-B8665P-02 Vet Use Only CUTTING NFS-2 18' (45 cm) 3/8 19mm'. Webster Veterinary Packet Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Sterile Suture Vet Use Only 26-B8665P-02 NFS-2 18' (45 cm) CUTTING 3/8 19mm'. Butler Box label includes: 'Butler 3/0 (2.0 metric) PROMEND Blue Monofilament Polypropelene 032002 Vet Use Only NFS-2 CUTTING 18' (45 cm) 3/8 19mm 01-B8665P-01 SUTUREVET'. Butler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 18' (45cm) 032002 PROMEND Blue Propylene Monofilament Synthetic Nonabsorbable Suture STERILE EO, Recall # Z-0808-2007;
c) Polydioxanone Violet monofilament synthetic absorbable suture withneedle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is sealed inside an inner foil pouch with an outside tyvek pouch. The outer tyvek pouch has the defective seal. Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE. Box Label includes: '3/0 (2.0 metric) MONO-DOX Violet Monofilament Polydioxanone Suture USP M398A CP-B-M398A-04 Rx Only NFS-2 19 mm 3/8 CUTTING Manufactured by: CP Medical Portland, OR USA 30' (75 cm) One Dozen Sterile Synthetic Absorbable Suture '. Packet Label includes:'3/0 (2.0 metric) 398 NFS-2 19mm 3/8 CUTTING 30' (75cm) POLYDIOXANONE Violet (PDO) Monofilament Synthetic Absorbable Suture STERILE EO. Product is also distributed under three private labels, Webster Veterinary Box Label includes: '3/0 (2.0 metric) WEBMAX Violet Monofilament Polydioxanone Suture Distributed by: WEBSTER VETERINARY 07-836-4288(M398A) 26-BM398A-01 Vet Use Only CUTTING NFS-2 30' (75 cm) 3/8 19mm'. Webster Veterinary Packet Label includes: '3/0 (2.0 metric) 07-836-4288(M398A) WEBMAX Violet Monofilament Polydioxanone Absorbable Sterile Suture 30' (75cm) Vet Use Only, CUTTING NFS-2 3/8 19mm 26-SM398A-01'. Butler Box label includes: 'Butler 3/0 (2.0 metric) MONOSORB Violet Monofilament Polydioxanone Suture 029254 Vet Use Only NFS-2 CUTTING 30' (75 cm) 3/8 19mm 01-BM398A-02 SUTUREVET'. Butler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 30' (75cm) 029254 MONOSORB Violet Monofilament Prolydioxanone Synthetic Absorbable Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'. Phoenix Pharmaceutical Box label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET MONOFILAMENT (Polydioxanone) Suture Sterile Synthetic Absorbable Suture 30' (75cm) Vet Use Only Cutting PFS-2 3/8 19mm. Phoenix Pharmaceutical Packet label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET MONOFILAMENT (Polydioxanone) Suture 30' (75cm) Sterile, Synthetic Absorbable Suture Veterinary Use Only Cutting PFS-2 3/8 19mm, Recall # Z-0809-2007

REASON: Potential for sterility of product to be compromised. Suture package seals incomplete or missing.

MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc, Parsippany, NJ, by visit beginning on January 18, 2007. Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is ongoing.

PRODUCT: STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer Diagnostica Stago France; Item Number: 56602, Recall # Z-0812-2007

REASON: Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on April 2, 2007 and May 3, 2007. Manufacturer: Becton Dickinson Medical Systems, Canaan, CT. Firm initiated recall is ongoing.

PRODUCT: BD 5mlSyringe Luer-Lok Tip Bulk Sterile Convenience Pak Latex Free, Recall # Z-0813-2007

REASON: Small cracks in plastic trays of one lot of BD 5mL Syringe Luer Lok Tp, Bulk Sterile Convenience Packs that may adversely affect tray integrity and steriity.

MANUFACTURER: GE Medical Systems LLC, Waukesha, WI, by visit beginning December 21, 2006. Firm initiated recall is ongoing.

PRODUCT: Definium AMX 700 Digital mobile x-ray system, Recall # Z-0821-2007

REASON: When using the Tech Switch on exposures, 750ms, 100 kVp and 100 mAs the exposure terminates prematurely.

MANUFACTURER:
Recalling Firm: Inverness Medical Professional Diagnostics, Scarborough, ME, by letter on March 28, 2007. Manufacturer: Puritan Medical Products Co., LLC, Guilford, ME. Firm initiated recall is ongoing.

PRODUCT:
a) BinaxNOW Influenza A&B 10 Test KIT Part Number: 416-110 contains NP Swabs with '8995' labeled on the swab wrapper, Recall # Z-0822-2007;
b) BinaxNOW Influenza A&B 22 Test Kit Part Number: 416-022, contains NP Swabs with '8995' labeled on the swab wrapper, Recall # Z-0823-2007;
c) BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on the swab wrapper, Recall # Z-0824-2007;
d) BinaxNOW Nasopharyngeal (NP) Accessory Pak, Part Number 400-065, contain NP Swabs with '8995' labeled on the swab wrapper, Recall # Z-0825-2007;
e) BinaxNOW A&B Kit 10 Test Kit (Japan) Part No. 416-110J contains NP Swabs with '8995' labeled on the swab wrapper, Recall # Z-0826-2007

REASON: Tip of the foam swab could detach from the shaft causing injury to the patient.

MANUFACTURER: Recalling Firm: Becton Dickinson and Company, Franklin Lakes, NJ, by telephone and letter on April 23, 2007. Manufacturer: Becton Dickinson Vascular Access S.A. de C.V., Nogales, Sonora Vexico. Firm initiated recall is ongoing.

PRODUCT: BD AutoShield Pen Needle, Recall # Z-0838-2007

REASON: Complaints were received regarding needle stick injuries while administering insulin to patients. Label will be revised to provide clear direction on product usage.

CLASS III

MANUFACTURER: Recalling Firm: Medtronic Neurological, Minneapolis, MN, on April 2007 by letter. Manufacturer: Medtronic A/S, Skovlunde, Denmark. Firm initiated recall is ongoing.

PRODUCT: Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071, Recall # Z-0817-2007

REASON: Medtronic pH 1.07 buffer solution lot #2610596 was mislabeled. The pink pH 1.07 buffer solution (catalog number 9012D1091) was placed in the pH 7.01 buffer solution bottle (catalog number 9012D1071).

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 23, 2007

CLASS II

MANUFACTURER: General Electric Med Systems, LLC, Waukesha, WI, by letter dated December 4, 2006 beginning December 21, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069, CT Scanner System, Recall # Z-0802-2007;
b) GE LightSpeed VCT Select / LightSpeed Pro32, Model 5126093, CT Scanner system, Recall # Z-0803-2007;
c) GE LightSpeed Pro 16 (100kW/80kW) Models 2357739, 2357739-3, 2357739-4, 2357739-6, 2357739-7 and 2357739-8, CT Scanner systems, Recall # Z-0804-2007;
d) GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems, Recall # Z-0805-2007;
e) GE Discovery VCT, Volume PET-CT scanner, Model 5124069-3, Recall # Z-0806-2007

REASON: Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 19, 2007. Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.

PRODUCT: Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122, Recall # Z-0810-2007

REASON: Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.

MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by representative visit beginning on January 18, 2007. Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is ongoing.

PRODUCT: STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer, Recall # Z-0812-2007

REASON: Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.

MANUFACTURER: bioMerieux, Inc, Durham, NC, by customer notification on December 19, 2006. Firm initiated recall is ongoing.

PRODUCT: BacT/VIEW® Software, all versions. in vitro diagnostic database software, Recall # Z-0814-2007

REASON: BacT/VIEW will be unable to run scheduled macro applications unless the user touches the BacT/VIEW touch screen or clicks a function after resynchronizing the clocks.

MANUFACTURER: GE Medical Systems LLC, Waukesha, WI, by visit beginning June, 2006. Firm initiated recall is ongoing.

PRODUCT: GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System, Recall # Z-0815-2007

REASON: To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software.

MANUFACTURER: Recalling Firm: Instrumentarium Dental, Inc, Milwaukee, WI, by letter dated April 28, 2006. Manufacturer: Soredex Palodex Group Oy, Tuusula, Finland. Firm initiated recall is ongoing.

PRODUCT: Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging, Recall # Z-0816-2007

REASON: There may be a material defect in the up/down movement axle of the unit. This may cause the upper part of the unit to suddenly come down.

CLASS III
MANUFACTURER: Biomet 3i, Palm Beach Gardens, FL, by telephone and letter on April 25, 2007. Firm initiated recall is ongoing.

PRODUCT: Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36, Recall # Z-0811-2007

REASON: The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 16, 2007:

CLASS II

MANUFACTURER: Datex – Ohmeda, Inc, Madison, WI, by letter on February 2, 2007. Firm initiated recall is ongoing.

PRODUCT: GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with software version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade), Recall # Z-0784-2007

REASON: There are two unique conditions with the Engstrom Carestation that require corrective action. These include an anomaly in the control of the safety relief valve and a situation where the display unit may reset

MANUFACTURER: Recalling Firm: Ciba Vision Corporation, Duluth, GA, by letter on April 30, 2007 and May 2, 2007. Manufacturer: Ciba Vision Puerto Rico, Inc, Cidra, PR. Firm initiated recall is ongoing.

PRODUCT: CIBASoft® Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10, Recall # Z-0793-2007

REASON: Base curve of the lenses does not meet specification.

MANUFACTURER: Recalling Firm: Ethicon, Inc, Somerville, NJ, by letter on April 20, 2007. Manufacturer: Ethicon SARL, Neuchatel, Switzerland. Firm initiated recall is ongoing.

PRODUCT: Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland, Recall # Z-0795-2007

REASON: The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01)

MANUFACTURER: Recalling Firm: Arjo, Inc, Roselle, IL, by letters dated January 5, 2007. Manufacturer: Arjo Hospital Equipment, Esloev, Sweden. Firm initiated recall is ongoing.

PRODUCT:
a) Maxi Move Patient Lift with Scale; Model KMBB4ELU2FUS, Recall # Z-0796-2007;
b) Maxi Move Patient Lift with Scale; Model KMBB4MSU2FUS, Recall # Z-0797-2007;
c) Maxi Move Patient Lift with Scale; Model KMBB4OLU2FUS, Recall # Z-0798-2007;
d) Maxi Move Patient Lift with Scale; Model KMBB4OSU2FUS, Recall # Z-0799-2007

REASON: The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place.

MANUFACTURER: 3M Espe Dental Products, Irvine, CA, by telephone or email starting on February 12, 2007. Firm initiated recall is ongoing.

PRODUCT: 3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricated of porcelainor composite, Recall # Z-0800-2007

REASON: Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.

CLASS III

MANUFACTURER: Recalling Firm: Boston Scientific, Maple Grove, MN, by letter on October 6, 2006.
Manufacturer: Boston Scientific Cork, Ltd, Cork, Ireland. Firm initiated recall is complete.

PRODUCT: Boston Scientific Medi-Tech Stainless Steel Greenfield Vena Cava Filter, order #50-400, Recall # Z-0794-2007

REASON: One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of 2008-07 and the correct date is 2008-06.

MANUFACTURER: BioHorizons Implant Systems, Inc, Birmingham, AL, by letters on April 18, 2007. Firm initiated recall is ongoing.

PRODUCT: Biohorizons 3 0mm Overdenture Implant System, REF 30120S2, (3 mm x 12 mm-2mm collar), Recall # Z-0801-2007

REASON: Dental implant system is missing ball attachment system.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 9, 2007:

CLASS II

MANUFACTURER: Recalling Firm: Teleflex Medical, Bannockburn, IL, by telephone and letter on March 1, 2007. Manufacturer: Truphatek, Ltd., Netanya, Israel. Firm initiated recall is complete.

PRODUCT: Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and 2 battery packs for use in Magnetic Resonance environments; catalog number 005852300, Recall # Z-0758-2007

REASON: The MRI Battery is out of specification for its magnetic content.

MANUFACTURER: Custom Ultrasonics, Ivyland,PA, by telephone and letters on December 12, 2005. Firm initiated recall is ongoing.

PRODUCT: 83 plus Mini-flex with accessory crate, Automatic Endoscope Reprocessor (AER) to clean and high level disinfect ENT/Bronch/Urology scopes between patient usage, Recall # Z-0770-2007

REASON: The device was marketed without a 510k.

MANUFACTURER: Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters on December 19, 2006. Manufacturer: Toshiba Medical Systems Corp., Tokyo, Japan. Firm initiated recall is ongoing.

PRODUCT: Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Recall # Z-0771-2007

REASON: Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature could exceed the 27 degrees Celsius limit as specified in the IEC safety standard.

MANUFACTURER: Recalling Firm: Graham-Field, Inc., Bay Shore,NY, by letter on April 3, 2007. Manufacturer: Dan Yang Ju Mad Healthcare Equipment Co., Ltd., Jietpai Town, Dan Yang, Jiangsu, China. Firm initiated recall is ongoing.

PRODUCT: Lumex® Walkabout Lite Four-Wheel Rollator, Recall # Z-0772-2007

REASON: The caster bolt stem/screw may loosen over time causing the wheel to come off.

MANUFACTURER: bioMerieux, Inc., Durham, NC, by letter on/about October 18, 2006 and October 31, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) BacT/ALERT Classic System Software, Blood Culturing System, Recall # Z-0773-2007;
b) BacT/ALERT 3D System Software, Blood Culturing System, Recall # Z-0774-2007;
c) BacT/ALERT 3D Combo Systems Software, Blood Culturing System, Recall # Z-0775-2007;
d) BacT/ALERT 3D 60 Systems Software, Blood Culturing System, Recall # Z-0776-2007

REASON: Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.

MANUFACTURER: Instrumentation Laboratory Co., Lexington, MA, by Service Reps and e-mail on March 21 and March 27, 2007. Firm initiated recall is ongoing.

PRODUCT: GEM Premier 4000 Laboratory Analyzer, Recall # Z-0778-2007

REASON: Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result.

MANUFACTURER: American Diagnostica, Inc., Stamford,CT, by letter and e-mail on February 28, 2007. Firm initiated recall is ongoing.

PRODUCT: American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic, Recall # Z-0779-2007

REASON: Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas.

MANUFACTURER: Orthopedic Systems Inc., Union City,CA, by letter on February 16, 2007. Firm initiated recall is ongoing.

PRODUCT: Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI's Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to support patients during spinal surgery, Recall # Z-0780-2007

REASON: Material used to manufacture accessory bracket does not meet product specification. The screw is normally composed of ''Torlon'', which is yellow. The part was made of "Tercite", which is blue.

MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown,PA, by letter on April 11, 2007. Manufacturer: B Braun of Puerto Rico, Inc., Sabana Grande,PR. Firm initiated recall is ongoing.

PRODUCT: B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets, Recall # Z-0783-2007

REASON: The integrity of the sterile product barrier may be compromised.

CLASS III

MANUFACTURER: Recalling Firm: Smith & Nephew, Inc Endoscopy Division, Oklahoma City,OK, by letter and telephone on January 19, 2007.
Manufacturer: Sopro Zac Athelia IV, La Ciotat Cedex, France. Firm initiated recall is ongoing.

PRODUCT:
a) SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France; Recall # Z-0781-2007;
b) SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France, Recall # Z-0782-2007

REASON: Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 2, 2007:

CLASS II

MANUFACTURER: Recalling Firm: Medi Manufacturing Inc., Whitsett, NC, by telephone and letter on August 11, 2006. Manufacturer: Medi Bayreuth, Bayreuth, Germany. Firm initiated recall is complete.

PRODUCT: Prosthetic Knee Joint (for external prosthesis, not implant), Recall # Z-0759-2007

REASON: Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications.

MANUFACTURER: Recalling Firm: Nellcor Puritan Bennett, Pleasanton, CA, by letter or personal contact beginning on March 12, 2007. Manufacturer: Puritan Bennett Ltd., Mervue, Ireland. Firm initiated recall is ongoing.

PRODUCT: Puritan Bennett 840 Ventilator System, Catalogue Numbers: 4-84O12OXXXX-XX, 4-840220XXXX-XX, 4-NPB84O-XX, DL4-NPB84O-XX, DS4-NPB840-XX & 4-070550-SP (Note: the Xs indicate any combination of alpha characters which specify option and language packs), Recall # Z-0760-2007

REASON: In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does not reset, the ventilator will detect a circuit disconnect condition. When this happens, the ventilator will annunciate a high-urgency audible alarm and the ventilator will not resume normal operation.

MANUFACTURER: Recalling Firm: Smiths Medical MD, Inc., Saint Paul, MN, by a 'Customer Information Bulletin' dated February 3, 2007 and a 'Product Recall Notification' dated February 16, 2007. Manufacturer: Medex Inc, Duluth, GA. Firm initiated recall is ongoing.

PRODUCT: Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4, Recall # Z-0768-2007

REASON: Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter on March 30, 2007. Manufacturer: Siemens AG MED, Erlangen, Germany. Firm initiated recall is ongoing.

PRODUCT: Magnetom Espree System with OR Table, Model number 10092082, Recall # Z-0769-2007

REASON: If table top is not seated properly it can lock up/stick.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of April 25, 2007

CLASS II

MANUFACTURER: Sunrise Medical, Somerset, PA, by telephone beginning on January 24, 2007 and by letter on January 29, 2007. Firm initiated recall is ongoing.

PRODUCT: a) DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder, Recall # Z-0731-2007; b) 535D-X CF Continuous Flow Cylinder, Recall # Z-0732-2007

REASON: Cylinder could lose oxygen at high pressure after the filling process

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA., by visit beginning March 21, 2007. Manufacturer: Siemens MED FG, Getafe-Madrid, Spain. Firm initiated recall is ongoing.

PRODUCT:
a) Mobilett XP, mobile X-ray system, Model number 1818454, Recall # Z-0749-2007;
b) Mobilett XP, mobile X-ray system, Model number 1818447, Recall # Z-0750-2007;
c) Mobilett XP, mobile X-ray system, Model number 1818363, Recall # Z-0751-2007

REASON: Mounting bolts for tank fork assembly and collimator flange may become loose.

MANUFACTURER: Rita Medical Systems, Inc., Manchester, GA., by letter beginning on April 2, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) RITA® Starburst™ XL (3-5 cm Diameter/25cm Length), Electro-surgical Device, Recall # Z-0752-2007;
b) RITA® StarBurst™ (2-3cm Diameter/25cm Length), Electro-surgical Device, Recall # Z-0753-2007;
c) RITA® Starburst™ MRI SemiFlex (3-5 cm Diameter/25cm Length), Electro-surgical Device, Recall # Z-0754-2007

REASON: The product may have a cracked tray which can compromise the sterility of the product.

MANUFACTURER: Recalling Firm: Conmed Corporation, Utica, NY, by letters dated March 5, 2007. Manufacturer: Katecho Inc, Des Moines, IA. Firm initiated recall is ongoing.

PRODUCT:
a) PADPRO™ ADULT Radiotranslucent Pad w/Zoll® connector. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, REF/Catalog # 2516Z. RX ONLY. Made in the USA, Recall Number: Z-0756-2007
b) PADPRO™ADULT Radiotranslucent Pad w/Medtronic® connector, REF/Catalog #2516M. RX ONLY. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes. Made in USA, Recall Number: Z-0757-2007

REASON: Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their specific device.

MANUFACTURER: Bio-Logic Systems Corp., Mundelein, IL, by letter on February 26, 2007. Firm initiated recall is ongoing.

PRODUCT: Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Model 580-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that includes a built-in pulse oximeter, body position sensor, snore monitor, chest, abdominal and air flow transducers and electrode array for EEG, EMG and EOG), Recall # Z-0761-2007

REASON: If the battery pack is installed into a Netlink Traveler unit incorrectly, a short in the wiring of the battery pack may occur and overheat the battery cells. This can cause the plastic overwrap material of the battery pack to melt and smoke.

MANUFACTURER: Recalling Firm: Bausch & Lomb, Inc., Rochester, NY, by letters on February 12 and February 20, 2007 and by e-mails on February 14, 2007.

Manufacturer: Promex Technologies, LLC, Franklin, IN. Firm initiated recall is ongoing.

PRODUCT:
a) Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX, Recall # Z-0765-2007;
b) Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No: CX4925, containing 1/25-ga. cutter along with accessories, RX, Recall # Z-0766-2007

REASON: The cutter probe tip breaks during use.

MANUFACTURER: Recalling Firm: Miltex, Inc., York, PA, by letter dated April 9, 2007.

Manufacturer: Kai Industries Co Ltd, Seki City, Gifu Prefecture, Japan. Firm initiated recall is ongoing.

PRODUCT: Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels, Recall # Z-0767-2007

REASON: Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex)

CLASS III

MANUFACTURER: Recalling Firm: Diasorin Inc., Stillwater MN, by telephone and faxed letter on March 14, 2007. Manufacturer: DiaSorin, S.p.A., Saluggia (VC), Italy. Firm Initiated is ongoing.

PRODUCT: DiSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum, Recall # Z-0755-2007

REASON: A lot to lot inconsistency was noted on kits of ETI EBNA G.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of April 18, 2007

CLASS II

MANUFACTURER: American Medical Systems, Minnetonka, MN, by letter on February 7, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, Recall # Z-0702-2007;
b) AMS DURA-II Universal Tips, 2 cm, Product Number 72009361, Sterile, Recall # Z-0703-2007

REASON: Mis-Labeling. The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.

MANUFACTURER: Coloplast Corp Skin Care Division, North Mankato, MN, by telephone on February 14, 2007. Firm initiated recall is ongoing.

PRODUCT: Sea-Clens Wound Cleanser, 6 fl. oz., #11701-159-36, #1063, Recall # Z-0710-2007,

REASON: Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).

MANUFACTURER: Recalling Firm: Joerns Healthcare Inc., Stevens Point, WI., by telephone on February 21, 2007. Manufacturer: Apex Health Care Mfg., Inc., Taiwan, Republic Of China. Firm initiated recall is ongoing.

PRODUCT: Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift), Recall # Z-0727-2007

REASON: Unapproved Design Change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds).

MANUFACTURER: Recalling Firm: Conmed Endoscopic Technologies, Inc., Billerica, MA, by letter dated March 14, 2007. Manufacturer: Angiomed GmbH & Co., Karlsruhe, Germany. Firm initiated recall is ongoing.

PRODUCT:
a) Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length, Item Number: LXB10040, Recall # Z-0729-2007;
b) Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10 mm diameter x 60 mm length, Item Number: LXB10060, Recall # Z-0730-2007

REASON: Blue safety clip incorrectly placed on the stent may prevent deployment

MANUFACTURER: Recalling Firm: Bio-Rad Laboratories Inc., Hercules, CA., by fax and telephone on February 12, 2007. Manufacturer: Inverness Medical Porfessional Diagnostics, San Diego, CA. Firm initiated recall is ongoing.

PRODUCT: Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Recall # Z-0733-2007

REASON: The product may produce a faint line which could be interpreted as a false negative test result.

MANUFACTURER: Roche Molecular Systems, Inc., Somerville, NJ, by letters on March 9, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics, Recall # Z-0734-2007;
b) AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc., Recall # Z-0735-2007

REASON: The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I rec., RNase-free, P/N 04716728001 (Roche Applied Science)". The Part Number listed for the DNase I listed is incorrect and of lower specific activity than the correct/validated DNase.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated March 16, 2007. Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.

PRODUCT: Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322, Recall # Z-0736-2007

REASON: The lower detection limit (LDL) may be a higher value than stated in the labeling.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by telephone on/or about February 28, 2007, and by letters dated March 2, 2007 or March 5, 2007. Firm initiated recall is ongoing.

PRODUCT: CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), Recall # Z-0737-2007

REASON: The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.

MANUFACTURER: Boston Scientific Corp., Glens Falls, NY, by letters dated June 13, 2006. Firm initiated recall is complete.

PRODUCT:
a) Vaxcel Implantable Vascular Access System -Titanium Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-315, UPN/Material No. M001453150, Single Use Only, STERILE, EO. The port is provided as a kit, with various single use, disposable items necessary for achieving vascular access and implanting the port catheter. Each kit is provided in a plastic (PETG) tray with a heat-sealed tyvek lid. This inner tray is then placed in a second outer plastic (PETG) tray, along with the Directions for Use, and also sealed with a tyvek lid which is then labeled. The port kit is placed in a cardboard carton, with additional labels and sealed, Recall # Z-0745-2007
b) Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-360, UPN/Material No. M001453600, Single Use Only, STERILE, EO. The port is provided as a kit, with various single use, disposable items necessary for achieving vascular access and implanting the port catheter. Each kit is provided in a plastic (PETG) tray with a heat-sealed tyvek lid. This inner tray is then placed in a second outer plastic (PETG) tray, along with the Directions for Use, and also sealed with a tyvek lid which is then labeled. The port kit is placed in a cardboard carton, with additional labels and sealed, Recall # Z-0746-2007

REASON: Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by their supplier B. Braun Medical of the error)

MANUFACTURER: Ortho-Clinical Diagnostics, Cardiff, UK, by letter and email on February 1, 2007. Firm initiated recall is ongoing.

PRODUCT: VITROS® Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD, Recall # Z-0747-2007

REASON: Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types.

CLASS III

MANUFACTURER: BioHorizons Implant Systems, Inc., Birmingham, AL, by letters and replacement drivers on March 12, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) Biohorizons 0.035 Hex Driver, REF 300-377, non-sterile, Rx only, REF 300-377, non-sterile, Rx only, Recall Z-0692-2007;
b) Biohorizons 0.050 Hex Driver, Regular, REF 300-350, non-sterile, Rx only,Recall # Z-0693-2007;
c) Biohorizons 0.050 Hex Driver, Long, REF 300-351, non-sterile, Rx only, Recall # Z-0694-2007

REASON: Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.

MANUFACTURER: Diasorin, Inc., Stillwater, MN, by email or fax on June 1, 2006. Firm initiated recall is ongoing.

PRODUCT: 1,25-Dihydroxyvitamin D RIA Kit. For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma, Part #65100E, Recall # Z-0707-2007

REASON: Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered invalid).

MANUFACTURER: Recalling Firm: Mega Diagnostics, Los Angeles, CA, by letter on March 9, 2007. Manufacturer: Pointe Scientific, Inc., Canton, MI. Firm initiated recall is complete.

PRODUCT:
a) Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials, Recall # Z-0743-2007;
b) Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials,Recall # Z-0744-2007

REASON: Potential for microorganism growth in the alcohol standard.

MANUFACTURER: Diasorin, Inc., Stillwater, MN, by letter, fax or email on February 15, 2007. Firm initiated recall is ongoing.

PRODUCT: DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples), Recall # Z-0748-2007

REASON: Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay).

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of April 11, 2007

CLASS II

MANUFACTURER: Recalling Firm: Draeger Medical, Inc., Telford, PA., by letter dated January 22, 2007. Manufacturer: Draeger Medical AG & Co., KG, Lubeck, Germany. Firm initiated recall is ongoing.

PRODUCT: Medical Air Compressor, Model # 8413419, Recall # Z-0674-2007

REASON: Compressors not providing sufficient supply pressure to connected medical ventilator.

MANUFACTURER: Scanlan International, Inc., Saint Paul, MN, by letter dated February 19, 2007. Firm initiated recall is ongoing.

PRODUCT: Scanlan International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, Recall # Z-0701-2007

REASON: Incorrectly assembled by manufacturer.

MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by letter dated January 16, 2007. Manufacturer Address: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.

PRODUCT: ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27, Recall # Z-0705-2007

REASON: In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.

MANUFACTURER: Abbott Laboratories, Santa Clara, CA., by letters on September 29, 2004. Firm initiated recall is complete.

PRODUCT: CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01, Recall # Z-0706-2007

REASON: Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range.

MANUFACTURER: Abbott Laboratories, Santa Clara, CA., by letters on April 17, 2006. Firm initiated recall is complete.

PRODUCT: CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems, List Number 01H73-01, Recall # Z-0708-2007

REASON: High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results that are unacceptable-out-of-range.

MANUFACTURER: Cenorin, Kent, WA, by letter dated December 20, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) ThermaSure Medical Device Drying Cabinet, series 130 Catalog #s 090035-00, 090035-03, 090036-00, 090036-02, Recall # Z-0711-2007
b) ThermaSure Medical Device Drying Cabinet, series 300, Catalog #s: 090033-02, 090033-04, 090034-02, 090034-04, Recall # Z-0712-2007;
c) ThermaSure Medical Device Drying Cabinet, series 1000, Catalog #s: 090010-02, 090010-04, 090011-00, 090011-02, Recall # Z-0713-2007

REASON: Potential for user to receive an electrical shock.

MANUFACTURER: Integra Biotechnical LLC, Vista, CA, by email and/or fax starting on February 1, 2007. Firm initiated recall is ongoing.

PRODUCT: ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625, Recall # Z-0714-2007

REASON: During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters.

MANUFACTURER Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by press release on March 5, 2006 and a customized Recall Notification Package on March 6, 2007. Manufacturer: Bausch & Lomb Inc., Greenville, SC. Firm initiated recall is ongoing.

PRODUCT: Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu® Multi-Purpose Solution, Equate Multi-Purpose Solution and Target Brand Multi-Purpose Solution. The product is distributed in up to three sizes: 4 fl. oz., 12 fl. oz. and 16 fl. oz, Recall # Z-0715-2007

REASON: A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.

MANUFACTURER: Pulse Biomedical, Inc., Norristown, PA, by telephone and letter dated March 5, 2007. Firm initiated recall is ongoing.

PRODUCT: QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine, Recall # Z-0716-2007

REASON: No 510 (k) marketing clearance for the product.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ., by letters on February 1, 2007. Manufacturer: Becton Dickinson & Co., Columbus, NB. Firm initiated recall is ongoing.

PRODUCT: BD 30ml Syringe Luer-Lok tip Sterile, Made in USA, Reorder number 309650, Recall # Z-0719-2007

REASON: The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size.

MANUFACTURER: Urologix, Inc., Minneapolis, MN, by letter dated March 16, 2007. Firm initiated recall is ongoing.

PRODUCT: Z-0720-2007
a) Urologix Microwave Delivery System 3.0 - 5.0. For use with prostatic urethra lengths of 3.0-5.0 cm only. Model TA1121D, Recall # Z-0720-2007;
b) Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of 2.5-3.5 cm only. Model TA1321D, Recall # Z-0721-2007

REASON: The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.

MANUFACTURER: Recalling Firm: Abbott Laboratories Inc., South Pasadena, CA., by letter dated January 30, 2007. Manufacturer: Microgenics Corp., Fremont, CA. Firm initiated recall is ongoing.

PRODUCT: Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20, Recall # Z-0722-2007

REASON: Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L).

MANUFACTURER: Hamilton Co., Reno, NV., by letter and email on January 30, 2007. Firm initiated recall is ongoing.

PRODUCT: Hamilton brand Disposable Precision Tips, Part Number 235300 (box containing 504 tips) and 235400 (case containing 20 boxes), Recall # Z-0723-2007

REASON: Some of the packaged tips have increased force during aspiration, which can lead to pipetting errors such as LLD error messages, and also has risk of causing a missed pipetting.

MANUFACTURER: Recalling Firm: Smith & Nephew, Inc., Endoscopy Div., Andover, MA., by letter on March 1, 2007. Manufacturer: Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA. Firm initiated recall is ongoing.

PRODUCT:
a) Smith & Nephew Suture Passer 12 inch, Part number: 7209166, Recall # Z-0724-2007;
b) Smith & Nephew Suture Passer 12 inch, Part number: 7209166D, (refurbished), Recall # Z-0725-2007;
c) Smith & Nephew Suture Passer 2 inch, Part number: 7209167, Recall # Z-0726-2007

REASON: Product is labeled as reusable but there is a potential that the Cannulated handle of the product cannot be cleaned adequately following use.

CLASS III

MANUFACTURER: Smiths Medical MD, Inc., Saint Paul, MN, by telephone on February 1, 2007. Firm initiated recall is ongoing..

PRODUCT: Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP); RX ONLY, Recall # Z-0718-2007

REASON: The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm message indicating that the pump requires servicing.

MANUFACTURER: Abbott Laboratories MPG, Abbott Park, IL, by letter dated February 19, 2007. Firm initiated recall is ongoing.

PRODUCT: ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Recall # Z-0728-2007

REASON: A small number of reagent kits were incorrectly configured. The affected kits contain either two bottles of conjugate or two bottles of assay diluent instead of one bottle of each.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of April 4, 2007

CLASS I

MANUFACTURER: Smith & Nephew, Inc., Endoscopy Div., Andover, MA., by letter on January 19, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Part Number: 7210270, Recall # Z-0662-2007;
b) RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210271, Recall # Z-0663-2007;
c) RF Denervation Probe, 15 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210272, Recall # Z-0664-2007

REASON: Product is non-sterile but labeled incorrectly as sterile.

CLASS II

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letters on February 24, 2007. Firm initiated recall is complete.

PRODUCT: CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Recall # Z-0640-2007

REASON: Incorrect Test Results. Product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that is unacceptable (out-of-range).

MANUFACTURER: Zimmer, Inc., Warsaw, IN., by visit on October 10, 2006. Firm initiated recall is complete.

PRODUCT:
a) NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272518, Recall # Z-0647-2007;
b) NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272519, Recall # Z-0648-2007;
c) NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272520, Recall # Z-0649-2007;
d) NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272521, Recall # Z-0650-2007;
e) NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272522,Recall # Z-0651-2007

REASON: The device was cut to an incorrect angle, which may result in an incorrect

MANUFACTURER: Siemens Medical Solutions, USA, Inc., Ann Arbor, MI., by letter dated January 29, 2007. Firm initiated recall is ongoing.

PRODUCT: Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system, Recall # Z-0652-2007

REASON: The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect.

MANUFACTURER: Medtronic Sofamor Danek USA Inc., Memphis, TN, by letter on February 2, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only, Rx only, Recall # Z-0653-2007;
b) Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, Rx only, Recall # Z-0654-2007

REASON: Bone screws may pull though the plate.

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone between January 12, 2007 and February 23, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400, Recall # Z-0655-2007;
b) Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401, Recall # Z-0656-2007;
c) Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405, Recall # Z-0657-2007;
d) Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406, Recall # Z-0658-2007;
e) Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410, Recall # Z-0659-2007

REASON: The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by letter on March 24, 3005. Firm initiated recall is complete.

PRODUCT: 8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Recall # Z-0660-2007

REASON: The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.

MANUFACTURER: Sonosite, Inc., Bothell, WA, by letter on February 5, 2007. Firm initiated recall is complete.

PRODUCT: MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer, Recall # Z-0661-2007

REASON: Laparoscopic ultrasound transducer exceeds the limits specified for radio-frequency emissions by up to 10db.

MANUFACTURER: Cook, Inc., Bloomington, IN, by telephone on February 28, 2007. Firm initiated recall is ongoing.

PRODUCT: Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0, Recall # Z-0665-2007

REASON: Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.

MANUFACTURER: Recalling Firm: superDimension, Inc. Minneapolis, MN., by letter on November 30, 2006 and by telephone beginning on December 1, 2006.

Manufacturer: Superdimension, Ltd., Herzliya, Israel. Firm initiated recall is ongoing.

PRODUCT:
a) superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract, Recall # Z-0666-2007;
b) Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01), Recall # Z-0667-2007

REASON: The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus System was used. The biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.

MANUFACTURER: Recalling Firm: Boston Scientific Target., Fremont, CA., by letter on February 7, 2007. Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland. Firm initiated recall is ongoing.

PRODUCT: Matrix2 Detachable Coils, for embolization of intracranial aneurysms. Catalog Number: 497204SR, UPN: M003497204SR0, Catalog Number: 494203, UPN: M0034942030, Recall # Z-0668-2007

REASON: The product may be missing the temperature indicator label on the inner pouch.

MANUFACTURER: Recalling Firm: Becton Dickinson & Co., Sparks, MD., by faxed letter dated February 19, 2007. Manufacturer: Becton Dickinson Caribe LTD, Cayey, PR. Firm initiated recall is ongoing.

PRODUCT: BD™ Sensi-Disc™ Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, Recall # Z-0669-2007

REASON: Antibiotic susceptibility testing reagent was not manufactured according to specifications and may cause ineffective treatment regimen in patients with infections. The recalling firm received customer reports of false susceptibility results.

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA., by service visit on April 12, 2006. Firm initiated recall is complete.

PRODUCT: Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm, Recall # Z-0670-2007

REASON: Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.

MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA., by letters on March 2, 2007. Firm initiated recall is ongoing.

PRODUCT: LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated external defibrillator (AED). The devices are designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, or public libraries. Affected part numbers: 3200731-000, 002, 006, 020 through 025, 040, 042, 043, 060, 062, 063, 080 through 084, 102, 103, 104, 120, 122, 124, 125, 140, 143, 145, 160, 163, 180, 182, 183, 202, 203, 222, 223, 242, 260, 261, 263, 282, 284, 400 and 403, and U3200731-002, Recall # Z-0671-2007

REASON: LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement.

MANUFACTURER: Remington Medical, Inc., Alpharetta, GA, by telephone on January 19, 2007. Firm initiated recall is complete.

PRODUCT: Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Recall # Z-0673-2007

REASON: Pouches were not sealed prior to sterilization.

MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated February 1, 2007. Firm initiated recall is ongoing.

PRODUCT: Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer, instrument for shoulder arthroplasty, REF no. 00-4309-021-00, Recall # Z-0675-2007

REASON: The reamer may lock up on the threads of the reamer body rather than spin freely as intended by design.

MANUFACTURER: E.M.S. – Electro Medical Systems SA, Nyon, Vaud, Switzerland, by letter on April 22, 2005. Firm initiated recall is ongoing.

PRODUCT: Swiss Lithocast Ultra Ultrasound Handpiece (EMS-PN: EL-236) used in combination with Swiss Lithoclast Ultra System, Recall # Z-0684-2007

REASON: Handpiece may become dislodged causing cable damage and possible electric shock.

MANUFACTURER: NDO Surgical, Inc., Mansfield, MA, by letter on January 26, 2007. Firm initiated recall is ongoing.

PRODUCT: Plicator EPS Plication System, Catalog Number: 160-01128R, Recall # Z-0685-2007

REASON: Device arm may fail to open after being deployed and require surgical intervention to remove.

MANUFACTURER: Aspyra, Inc., Calabasas, CA, by letter on January 31, 2007. Firm initiated recall is ongoing.

PRODUCT: Aspyra, Inc. CyberMed Version 2.1 Pharmacy Software, Recall # Z-0686-2007

REASON: Medications prescribed for one patient were printed on the Medication Administration Record (MAR) of another patient.

MANUFACTURER: Recalling Firm: Boston Scientific Corp., Natick, MA., by letter dated January 24, 2007. Manufacturer: Nexcore Technology, Inc., Waldrick, NJ. Firm initiated recall is ongoing.

PRODUCT:
a) Product Description: HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system), Recall # Z-0687-2007;
b) HTA Console System, 230 Volt, English, Product Number: 560010 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system), Recall # Z-0688-2007;
c) HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation Unit (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system), Recall # Z-0689-2007;
d) HTA Console System, 230 Volt , French, Product Number: 56001FO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system), Recall # Z-0690-2007;
e) HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system), Recall # Z-0691-2007;

REASON: Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment.

MANUFACTURER: Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO., by letter on December 19, 2006. Manufacturer: Gambro Lundia Ab - Disposables Division, Lund, Sweden. Firm initiated recall is ongoing.

PRODUCT: Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Recall # Z-0695-2007

REASON: Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)

MANUFACTURER: Boston Scientific Corp., Natick, MA, by letter dated February 1, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) Boston Scientific SpyGlass Visualization Probe Reference Number: 4603, UPN M00546030, Recall # Z-0696-2007;
b) Boston Scientific SpyGlass Ocular Reference Number: 4604, UPN M00546040, Recall # Z-0697-2007;
c) Boston Scientific SpyGlass Light Cable Reference Number: 4621 UPN M00546210, Recall # Z-0698-2007;
d) Boston Scientifica SpyGlass Camera Ref Number: 4610 UPN M00546100, Recall # Z-0699-2007

REASON: SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe

MANUFACTURER: GE OEC Medical Systems,Inc., Salt Lake City, UT, by firm representative visit beginning in April, 2004. Firm initiated recall is complete.
PRODUCT: InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body), Recall # Z-0704-2007
REASON: Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.

CLASS III

MANUFACTURER: BD Opthalmic Systems, Waltham, MA., by telephone on March 2, 2007 and followed with a letter. Firm initiated recall is ongoing.

PRODUCT: BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618, Recall # Z-0672-2007

REASON: Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)

MANUFACTURER: Advanced Bionics Corp., Sylmar, CA, by visit on January 31, 2007 and by letter on March 8, 2007. Firm initiated recall is ongoing.

PRODUCT: The Precision Implantable Pulse Generator, Model Number SC-1110, Recall # Z-0700-2007

REASON: The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 28, 2007:

CLASS I

MANUFACTURER: Matrix Distributors, Inc., E Brunswick, NJ, by telephone from October 9 to October 13, 2006. A follow-up letter (January 19, 2007) was issued to the pharmacies extending the recall to the user level. Firm initiated recall is ongoing.

PRODUCT:
a) One Touch Ultra Blood Glucose Test Strips,
b) One Touch Ultra Basic/Profile Test Strips, Recall # Z-0477-2007

REASON: Counterfeit Test Strips (manufacturer unknown)

MANUFACTURER: Recalling Firm: HoMedics, Inc., Commerce Township, MI, by press release and letter on February 9, 2007. Manufacturer: Teamedics, Shenzhen, China. Firm initiated recall is ongoing.

PRODUCT:
a) HoMedics Thera P Standard size Dry Heating Pad; Model No. HP-100, UPC 031262003621, Recall # Z-0622-2007;
b) Thera-P Standard size Moist/Dry Heating Pad, Model No. HP-150 (UPC 031262003638) and sold as Walgreens by HoMedics model number 802857 (UPC 04922149892),Recall # Z-0623-2007;
c) HoMedics Thera P Standard size Moist/Dry Heating Pad with Auto Shut-off, Model No. HP-200 (UPC 031262007926), Recall # Z-0624-2007;
d) HoMedics Thera P King size Moist/Dry Heating Pad; Model No. HP-300 (UPC 031262003645), Recall # Z-0625-2007;
e) HoMedics Thera P Model King size Moist/Dry Heating Pad with Auto Shut-off; Model No. HP-500 (UPC 031262003652), Recall # Z-0626-2007

REASON: Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.

CLASS II

CLASS II MEDICAL DEVICE RECALL EXTENSION
Originally listed in the December 27, 2006 Enforcement Report:

MANUFACTURER: Recalling Firm: KaVo America Corp, Lake Zurich IL, by letter, telephone and email on November 22, 2006.

******* KaVo expanded the recall to include the replacement cans with lot numbers ending in R3X via letters dated 2/26/07. The instructions and recall strategy remain the same as in the 11/22/06 letter, but requesting the dealers to notify their customers by 2/28/07. The QUATTROcare Spray will be replaced with Kavo Spray until the problem with the QUATTROcare Spray is resolved.

Manufacturer: Kaltenbach & Voigt Gmbh & Co. KG, Biberach, Germany. Firm initiated recall is ongoing.
PRODUCT: KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenance unit only; Made in Germany The spray was produced under the following labels: a) KaVo QUATTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, single can: item #04117630, type 2106, 6-pack: item #04117640, type 2106A b) KaVo QUATTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, single can: item #04117680, type 2107, 6-pack: item #04117690, type 2107A c) KaVo QUATTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, single can: item #04117590, type 2108, 6-pack: item #04117720, type 2108A, Recall # Z-0289-2007

REASON: The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury.

MANUFACTURER: Gebauer Company, Cleveland, OH, by letters dated January 23, 2007, February 13, 15, 22, 2007 and by press release on March 1, 2007. Firm initiated recall is ongoing.

PRODUCT: Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75, Recall # Z-0497-2007

REASON: Microbial Contamination. Certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing.

MANUFACTURER: GE OEC Medical Systems, Inc, Salt Lake City, UT, by telephone on February 9, 3007 and site visit on February 12, 2007. Firm initiated recall is complete.

PRODUCT:
a) OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery, Recall # Z-0556-2007;
b) OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System, Recall # Z-0557-2007;
c) OEC 9800 Plus Fluoroscopic X-ray System, Recall # Z-0558-2007;
d) OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System, Recall # Z-0559-2007

REASON: During routine service, a cover may have been installed without the required proper lead shielding.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp, Round Lake, IL, by letters on November 27, 2006. Manufacturer: Baxter Healthcare Corp, Singapore. Firm initiated recall is ongoing.

PRODUCT:
a) Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished), Recall # Z-0632-2007;
b) Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished), Recall # Z-0633-2007;
c) Baxter Flo-Gard 6200 Volumetric Infusion Pump, catalog #2M8043, 2M8043R (refurbished), Recall # Z-0634-2007;
d) Baxter Flo-Gard 6300 Dual Channel Volumetric Infusion Pump, catalog #2M8048, 2M8048R (refurbished), Recall # Z-0635-2007

REASON: There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter.

MANUFACTURER: Phillips Medical Systems (Cleveland) Inc, Cleveland, OH, by letter on October 4, 2006 and October 25, 2006. Firm initiated recall is ongoing.

PRODUCT: Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1), Recall # Z-0636-2007

REASON: Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data.

MANUFACTURER: Viasys Respiratory Care, Inc.dba Bird Products, Palm Springs, CA, by letter on January 31, 2007. Firm initiated recall is ongoing.

PRODUCT: VIASYS VELA Ventilator, Viasys Respiratory Care, Inc., Recall # Z-0638-2007

REASON: The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letters on February 24, 2004. Firm initiated recall is complete.

PRODUCT: CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Recall # Z-0640-2007

REASON: Incorrect Test Results. Product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).

MANUFACTURER: bioMerieux, Inc., Durham, NC, by letter on January 12, 2007. Firm initiated recall is ongoing.

PRODUCT: BacT/ALERT® FA Culture Bottles, 30 ml, for in vitro diagnostic use, Recall # Z-0643-2007

REASON: Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.

MANUFACTURER: bioMerieux, Inc., Durham, NC, by letter on December 20, 2007. Firm initiated recall is ongoing.

PRODUCT: BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, Recall # Z-0644-2007

REASON: Bottle data is not sent to BacT/ALERT 3D instrument.

MANUFACTURER: Recalling Firm: Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY, by email on November 9, 2006. Manufacturer: Stratec Biomedical Systems AG, Birkenfeld, Germany. Firm initiated recall is ongoing.

PRODUCT: ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer, Recall # Z-0645-2007

REASON: Firm received complaints for signal 2 & 4 errors, and shifts in Relative Light Units (RLU). Investigations showed that the On-Board Stability (OBS) of the acid & base reagents may be compromised after 4 days after installation onto the Centaur CP system due to evaporation.

CLASS III

MANUFACTURER: Recalling Firm: Boston Scientific, Maple Grove, MN, by letter dated December 12, 2006. Manufacturer: Boston Scientific Corporation, Miami, FL. Firm initiated recall is ongoing.

PRODUCT: Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e. heparin, saline, thrombolytic agents, etc.) in the peripheral vasculature. The wire allows for the delivery of agents in either a "pulse-spray" or "slow weep" technique. Order No. REF: 46-193 (M001461930), Recall # Z-0642-2007

REASON: Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was manufactured using the Katzen Core Assembly of 146 cm, instead of a 177cm assembly.

MANUFACTURER: Thyro Tec Inc., Honey Brook, PA, by letters on January 24, 2007 and February 5, 2007. Firm initiated recall is ongoing.

PRODUCT: Thyrotest TSH POC Rapid membrane test. In vitro diagnostic, Product Code 1020, Recall # Z-0646-2007

REASON: Positive control showed little or no positive line.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 21, 2007

CLASS II

MANUFACTURER: Recalling Firm: Conmed Corporation, Utica, NY, by letters dated November 10, 2006. Manufacturer: SEISA, Sarabia Parque Industrial, Aeropuerto Jaurez, Mexico. Firm initiated recall is ongoing.

PRODUCT:
FRAZIER Surgical Suction Instrument, 3 Fr. with Control Vent and Obturator, REF 0031030. Assembled in Mexico, Recall # Z-0584-2007;
b) FRAZIER Surgical Suction Instrument, 5 Fr. with Control Vent and Obturator, REF 0031050. Assembled in Mexico, Recall # Z-0585-2007;
c) FRAZIER Surgical Suction Instrument, 7 Fr. with Control Vent and Obturator, REF 0031070. Assembled in Mexico, Recall # Z-0586-2007;
d) FRAZIER Atraumatic Soft Tip Surgical Suction Instrument with Control Vent and Obturator, 10 French, REF 0031100. Assembled in Mexico, Recall # Z-0587-2007;
e) FRAZIER Surgical Suction Instrument, 8 Fr. with Control Vent and Obturator, REF 0033080. Assembled in Mexico, Recall # Z-0588-2007;
f) FRAZIER Surgical Suction Instrument, 10 Fr. with Control Vent and Obturator, REF 0033100. Assembled in Mexico, Recall # Z-0589-2007;
g) FRAZIER Surgical Suction Instrument, 12 Fr. with Control Vent and Obturator, REF 0033120. Assembled in Mexico, Recall # Z-0590-2007;
h) FRAZIER Surgical Suction Instrument, 18 Fr. with Obturator, REF 0033180. Assembled in Mexico, Recall # Z-0591-2007;
i) FRAZIER Olive Tip Suction Instrument, 10 Fr. with Control Vent and Obturator (Bend with Obturator in Place), REF 0033110. Assembled in Mexico, Recall # Z-0592-2007;
j) POOLE Suction Instrument, REF 0035040. Assembled in Mexico, Recall # Z-0593-2007

REASON: Firm was made aware of instances where the sterile barrier of the instruments had been compromised.

MANUFACTURER: Recalling Firm: Inverness Medical Professional Diagnostics, Princeton NJ, by letters on February 14, 2007 Manufacturer: Agen Biomedical, Ltd., Acacia Ridge, Australia. Firm initiated recall is ongoing.

PRODUCT: Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Product No. 61100KVC 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide 10 plastic pipettes, Recall # Z-0594-2007

REASON: Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.

MANUFACTURER Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on December 20, 2006. Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. Firm initiated recall is ongoing.

PRODUCT:
a) Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100, Recall # Z-0604-2007;
b) Wallstent Endoscopic Biliary Endoprosthesis 8mm x 60mm, UPN H965430200,Recall # Z-0605-2007;
c) Wallstent Endoscopic Biliary Endoprosthesis 8mm x 80mm, UPN H965430300,Recall # Z-0606-2007;
d) Wallstent Endoscopic Biliary Endoprosthesis 10mm x 40mm, UPN H965430400,Recall # Z-0607-2007;
e) Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500;Recall # Z-0608-2007;
f) Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600,Recall # Z-0609-2007

REASON: Guidewire restriction during use (excessive adhesive in the guidewire lumen).

MANUFACTURER: Guidant Cardiac Surgery, Santa Clara, CA, by teleconference on December 1, 2006 and by letters on December 4, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000, Recall # Z-0611-2007; b) Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100, Recall # Z-0612-2007

REASON: Vacuum Tubing Failure. Vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.

MANUFACTURER:: Recalling Firm: Gyrus ACMI Corp., by letters on February 19, 2007. Manufacturer: Gyrus Medical, Inc., Maple Grove, MN. Firm initiated recall is ongoing.

PRODUCT:
a) Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32, Recall # Z-0613-2007;
b) Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901, Recall # Z-0614-2007;
c) Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number: 006689-903, Recall Z-0615-2007

REASON: Product sterility may be compromised due to failure of the tray seal packaging.

MANUFACTURER: Stentor Inc., A Phillips Medical Systems Co., Foster City, CA, by letter on February 14, 2007. Firm initiated recall is ongoing.

PRODUCT: The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data throughout a clinical environment, Recall # Z-0616-2007

REASON: A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical orientation markers may be reversed.

MANUFACTURER: Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter dated December 12, 2006. Firm initiated recall is ongoing.

PRODUCT: Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268, Recall # Z-0617-2007

REASON: Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter on February 16, 2007. Manufacturer: Baxter Productos Medicos Ltda., Cartago, Costa Rica. Firm initiated recall is ongoing.

PRODUCT:
a) Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP 12 inch pump segment, 0.22 micron downstream high pressure filter, Luer activated valve, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; Baxter Healthcare, Deerfield, IL 60015; product code 2C8857, Recall # Z-0618-2007;
b) Baxter Interlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; product code 2C7557, Recall # Z-0619-2007;
c) Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; product code 2C7553, Recall # Z-0620-2007

REASON: Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.

MANUFACTURER: Remel, Inc., Lenexa, KS., by letters dated February 19, 2007. Firm initiated recall is ongoing.

PRODUCT: Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box, Recall # Z-0621-2007

REASON: Some of the units exhibited false negative results for sorbitol fermenting bacteria such as E. Coli 0157.

MANUFACTURER: Recalling Firm: Merit Medical Systems, Inc., South Jordan, UT, by letter on February 23, 2007. Manufacturer: Unomedical, Ltd., Stonehouse, Glos, UK. Firm initiated recall is ongoing.

PRODUCT:
a) StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Recall # Z-0627-2007;
b) StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Recall # Z-0628-2007;
c) EpiFix Fixation Device for Epidural Catheters, REF 670M, Recall # Z-0629-2007

REASON: Sterility of some units may be compromised due to damaged packaging.

MANUFACTURER: Recalling Firm: Boston Scientific Corp., Glens Falls, NY, letters dated September 27, 2006. Manufacturer: Boston Scientific Corp., Glens Falls NY. Firm initiated recall is complete.

PRODUCT:
a) Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150, Recall # Z-0630-2007;
b) Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Silicone Catheter, REF/Catalog No. 45-220, UPN/Material No. M001452200, Recall # Z-0631-2007

REASON: Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised.

MANUFACTURER: Cook, Inc., Bloomington, IN, by telephone on January 2, 2007. Firm initiated recall is ongoing.

PRODUCT: COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum® Glide® Antimicrobial Catheter with EZ--Pass® Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A, Recall # Z-0637-2007

REASON: These catheters do not include the proximal sidehole as required by the specification.

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letters on May 12, 2004. Firm initiated recall is complete.

PRODUCT: CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Recall # Z-0639-2007

REASON: Incorrect Test Results. Test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).

CLASS III

MANUFACTURER: Abbott Molecular, Des Plaines, IL, by telephone and/or letters on December 22, 2006. Firm initiated recall is ongoing.

PRODUCT: Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025, Recall # Z-0595-2007

REASON: The LSI D13S319 SO/13q34 SA/CEP 12 SG probe of the two mixture DNA-Probe was contaminated with LSI ATM SG/p53 SO probe. This contamination would result in 10 FISH signals in each normal cell rather than the expected 6 FISH signals in each normal cell.

MANUFACTURER: Recalling Firm: Alcon Research, Ltd, Fort Worth, TX, by visit and by letter on January 22, 2007. Manufacturer: Alcon Grieshaber AG, Schaffhausen, Switzerland. Firm initiated recall is complete.

PRODUCT: 19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32, Recall Z-0610-2007

REASON: Product is misbranded; 19 gauge Schlera Plugs distributed in containers labeled as 19 gauge Trochar Cannula Plugs.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 14, 2007:

CLASS I

MANUFACTURER: Defibtech, LLC, Guilford, CT, by email on February 17, 2007 and by letters on February 22, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as "Lifeline AED" brand -Model DDU-100A (version 2.002 and earlier), Recall # Z-0580-2007;
b) Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as "ReviveR AED" brand -Model DDU-100B (version 2.002 and earlier), Recall # Z-0581-2007

REASON: Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.

CLASS II

MANUFACTURER: Siemens Medical Solutions Diagnostics, Flanders, NJ, by fax on January 15, 2007. Firm initiated recall is ongoing.

PRODUCT: Sample Management System software for in vitro diagnostic testing Product # 030102-03, Recall # Z-0545-2007

REASON: Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.

MANUFACTURER: Alcon Laboratories, Inc., Houston, TX, by telephone, fax and letter on December 22, 2006 and December 26, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) Alcon Custom-Pak®, part #10975-02, containing BD Beaver™ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized, Recall # Z-0560-2007;
b) Alcon Custom-Pak®, part #2638-17, containing BD Beaver™ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized, Recall # Z-0561-2007;
c) Alcon Custom-Pak®, part #4917-54, containing BD Beaver™ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized, Recall # Z-0562-2007;
d) Alcon Custom-Pak®, part #6515-51, containing BD Beaver™ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized, Recall # Z-0563-2007;
e) Alcon Custom-Pak®, part #11148-02, containing BD Beaver™ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized, Recall # Z-0564-2007

REASON: Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.

MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA., by letter on September 12, 2006. Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
PRODUCT: Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5), Recall # Z-0566-2007

REASON: There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.

MANUFACTURER: Wright Medical Technology Inc., Arlington, TN, by telephone on January 3, 2007 and letters on January 15, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm O.D., use with 22 mm Head, Recall # Z-0567-2007;
b) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm O.D., use with 36 mm Head, Recall # Z-0568-2007;
c) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm O.D., use with 36 mm Head, Recall # Z-0569-2007;
d) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis, REF: GLBP-3652, Size 52mm O.D., use with 36 mm Head, Recall # Z-0570-2007;
e) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis, REF: GLBP-3653, Size 53mm O.D., use with 36 mm Head,Recall # Z-0571-2007;
f) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm O.D., use with 36 mm Head, Recall # Z-0572-2007;
g) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis, REF: GLBP-3655, Size 55mm O.D., use with 36 mm Head,
Recall # Z-0573-2007

REASON: Product specification failure which could result in improper locking of the cup onto the femoral head.

MANUFACTURER: Abiomed, Inc., Danvers, MA, by letter dated January 8, 2007. Firm initiated recall is ongoing.

PRODUCT: AB5000 Console Circulatory Support System, Catalog number: 0015-000, Recall # Z-0574-2007

REASON: Unit may alarm “Low Pressure” due to manufacturing material in the pressure source.

MANUFACTURER: Abbott Vascular Inc., Redwood City, CA, by letters on January 31, 2007. Firm initiated recall is ongoing.

PRODUCT: StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677, Recall # Z-0575-2007

REASON: Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.

MANUFACTURER: Ekos Corp, Bothell, WA, by letter on February 9, 2007. Firm initiated recall is ongoing.

PRODUCT: EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA Packaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. and ''Lysus Infusion System''. EndoWave Infusion Systems 06, 2.7W, part #4599-001, catalog #500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #500-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part 4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog #500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, catalog #500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130, Systems 40, 3.5W, part #5199-006, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150; Lysus Infusion Systems 06, 2.7W, part #4599-001, catalog 500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #50-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part #4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog 500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, 500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130; Systems 40, 3.5W, part #5199-005, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150, Recall # Z-0577-2007

REASON: Ekos Corporation received three reports that distal radiopaque marker bands on the EndoWave Drug Delivery Catheter became detached from the catheter during use and remained in the patient.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by visit beginning February 1, 2007. Manufacturer: Siemens Medical Solutions, Forchheim, Germany. Firm initiated recall is ongoing.

PRODUCT:
a) AXIOM Artis MP, Angiographic x-ray system, model number 5904466, Recall # Z-0578-2007;
b) AXIOM Artis MP, Angiographic x-ray system, model number 7555365, Recall # Z-0579-2007

REASON: C-arm gantry could rapidly descend without command during use.

MANUFACTURER: Kensey Nash Corp, Exton, PA, by email on February 7, 2007 and fax on February 9, 2007. Firm initiated recall is ongoing.

PRODUCT: ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow, Recall # Z-0597-2007

REASON: Face seal may wear excessively and cause particulate matter.

CLASS III

MANUFACTURER: Abbott Laboratories MPG, Abbott Park, IL, by letters dated December 29, 2006. Firm initiated recall is ongoing.

PRODUCT: Architect i System Assay CD-ROM, U.S. Version 21.0, for use on the Architect i System, list number 06E58-21, in vitro diagnostic, Recall # Z-0413-2007

REASON: The Architect Ausab and Architect Anti-HCV assay parameter default interpretation screens when using Architect Assay CD-ROM US Version 06E58-21 does not align with the result interpretation options in the Architect Ausab Reagent Package Insert (PI) 34-4162/R1 and ARCHITECT Anti-HCV PI 34-4152/R1.

MANUFACTURER: Medtronic Xomed, Inc., Jacksonville, FL, by telephone on January 22, 2007, and then a follow-up fax letter on February 2, 2007. Firm initiated recall is ongoing.

PRODUCT: AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection needles and 10 nonsterile surface electrodes that are packaged 2 per non-breathable pouch, but are not sterilized, Recall # Z-0576-2007

REASON: A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection Needles and 10 non-sterile Surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as “sterile”.

MANUFACTURER Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by letter on December 29, 2006. Manufacturer: Medtronic Mexico, S. De R. L. De C.V. Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.

PRODUCT: Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine. This tubing is connected to the cannula in the patient in order to divert blood to the circuit when the patient is on bypass, Recall # Z-0583-2007

REASON: One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.

MANUFACTURER: Recalling Firm: J. Jamner Surgical Instruments, Inc. Hawthorne, NY, by letter dated November 14, 2006. Manufacturer: Koros USA Inc., Moorpark, CA. Firm initiated recall is ongoing.

PRODUCT: JariTrak™ Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The JariTrak™ Table Clamp with vertical post (206-160) is part of the Table Mounted Hardware that is used with the JariTrak™ Retractor System. The JariTrak™ self-retaining retractor system consists of the Table Clamp with Vertical Post, Flexible or Horizontal Bar with Universal Joint, Oval or Segment Rings, Tilting Blade Clamps and various blades. The product is supplied non-sterile and may be packaged individually or as part of the JariTrak™ retractor set, Recall # Z-0596-2007

REASON: The JariTrak™ Table Clamp may not securely fasten to the bed rail of the OR table during set up of the retractor system. In the event that the clamp is not securely fastened to the bed rail, the system may move during surgery. The firm received several complaints from hospitals.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 7, 2007:

CLASS I

MANUFACTURER: Safety & Supplies Co, Inc, East Brunswick, NJ, by letter on February 2, 2007. Firm initiated recall is ongoing.

PRODUCT: One Touch Basic/Profile and One Touch Ultra-Blood Glucose Test strips- 50-count, Recall # Z-0547-2007

REASON: Counterfeit product (manufacturer unknown)

CLASS II

MANUFACTURER: Recalling Firm: Stryker Leibinger USA, Portage MI, by letter dated December 22, 2006. Manufacturer: Stryker Leibinger Gmbh, Freiburg, Germany. Firm initiated recall is ongoing.

PRODUCT: Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401); Part 01-15407, Recall # Z-0521-2007

REASON: Metal shavings come off of the plug as a result of friction between the plug and the cutting cylinder, and may be mixed with the milled bone chips.

MANUFACTURER: Exactech, Inc., Gainesville, FL, by letter dated December 8, 2006. Firm initiated recall is ongoing.

PRODUCT: Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component, Knee prosthesis. Catalog number: 204-11-13, Recall # Z-0522-2007

REASON: The outside profile on this manufactured lot of devices is oversized and does not meet specifications.

MANUFACTURER: Spacelabs Healthcare, Incorporated, Issaquah, WA, by letter on January 3, 2007. Firm initiated recall is ongoing.

PRODUCT: Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor, Recall # Z-0523-2007

REASON: Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and Sp02 alarm limits being frozen. This can result in delay in treatment.

MANUFACTURER: Recalling Firm: Biosense Webster, Inc., Irwindale, CA, by letters on November 20, 2006 and December 9, 2006. Manufacturer: Cordis de Mexico, S.A. de C.V., Cd. Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.

PRODUCT:
a) Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803MS, Recall # Z-0537-2007;
b) Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803M, Recall # Z-0538-2007;
c) Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301805M, Recall # Z-0539-2007;
d) Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803A, Recall # Z-0540-2007;
e) Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803P, Recall # Z-0541-2007

REASON: Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.

MANUFACTURER: Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated December 20, 2006. Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.

PRODUCT: LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System, Recall # Z-0542-2007

REASON: The tubing can separate from the set at the filter inlet post.

MANUFACTURER: Recalling Firm: GMP Companies/Lifesync Corp., Ft. Lauderdale, FL, by letter on January 15, 2007. Manufacturer: Printec H. T. Electronics Corp., Chung-Ho City, Taipei Hsien. Firm initiated recall is complete.

PRODUCT: LifeSync ECG System – Disposable leadwear, Ls-222, Ls-223, Recall # Z-0546-2007

REASON: When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation.

MANUFACTURER: Clark Research and Development, Inc., Folsom, LA, by letter dated January 19, 2007 and February 5, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over activated carbon, 50mL, Recall # Z-0550-2007;
b) Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over activated carbon, 100mL, Recall # Z-0551-2007;
c) Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over activated carbon, 175 mL, Recall # Z-0552-2007;
d) Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over activated carbon, 250mL, Recall # Z-0553-2007

REASON; Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter on January 27, 2007. Manufacturer: BD Medical - Diabetes Care, Holdrege, NE. Firm initiated recall is ongoing.

PRODUCT: BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle 1 ml 29g 1/2' (0.33mm x 13 mm) Re-Order No. 305282 U-100 insulin , Recall # Z-0582-2007

REASON: The needle becomes detached from the hub/syringe

CLASS IIl

MANUFACTURER: Diagnostic Chemicals, Ltd., Charlottetown, Prince Edward Island, Canada, by telephone and fax on September 6, 2006. Firm initiated recall is ongoing.

PRODUCT: Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252, Recall # Z-0536-2007

REASON: Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct

MANUFACTURER: Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by telephone on December 7, 2006. Firm initiated recall is complete.

PRODUCT:
a) Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4" connector, arterial cannula, 10 FR, 17.5 cm (7") long; Catalog no. L7350, Z-0543-2007;
b) Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4" connector, arterial cannula, 12 FR, 17.5 cm (7") long; Catalog no. L7351, Recall # Z-0544-2007

REASON: The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4".

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letter on December 22, 2006. Firm initiated recall is ongoing.
PRODUCT: CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers, Recall Z-0565-2007
REASON: Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 28, 2007:

CLASS II

MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle, IL, by letters dated January 9, 2007. Manufacturer: Medibo N.V., Achel, Belgium. Firm initiated recall is ongoing.

PRODUCT:
a) Sara Active Sling, patient lift - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240,
Recall # Z-0424-2007;
b) Sara Active Sling, patient lift - Wide; item KKX00120.0 - models KA1231 (with safety) and KA1241, Recall # Z-0425-2007;
c) Sara Active Sling, patient lift - Standard; item KK53210.0 - model KA1210 (with safety), Recall # Z-0426-2007

REASON: There is the potential for the slings to come apart, potentially allowing injury to the patient.

MANUFACTURER: Ciba Vision Corporation, Duluth, GA, by letter on January 12, 2007. Firm initiated recall is ongoing.

PRODUCT: O²Optix™ (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package), Recall # Z-0427-2007

REASON: Reduced lon Permeability

MANUFACTURER: Taut, Inc., Geneva, IL, by letters dated January 19, 2007. Firm initiated recall is ongoing.

PRODUCT: Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; the individually packaged, sterilized catheter was sold in two configurations: a) catalog number (REF) P.I.-128: 10 catheters per box, 10 boxes per case, and b) a sterile component of the convenience kit, catalog number (REF) 50000, System One Comprehensive Lap CBDE Kit, Recall # Z-0428-2007

REASON: Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.

MANUFACTURER: Recalling Firm: Abbott Laboratories MPG, Abbott Park, IL, by letter dated August 11, 1006. Manufacturer: Axis-Shield Diagnostics, Ltd., The Technology Park, Dundee, Scotland, UK. Firm initiated recall is complete.

PRODUCT: IMx Sirolimus Reagent Pack, in vitro diagnostic; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM, Recall # Z-0501-2007

REASON: The sirolimus values may shift higher after storage at 2-8°C or after one freeze/thaw cycle of specimens.

MANUFACTURER: Cook Endoscopy, Winston Salem, NC, by letters on/about January 31, 2007. Firm initiated recall is ongoing.

PRODUCT: Quantum TTC Biliary Balloon Dilation Catheter, Order number QBD-10X3, Recall # Z-0520-2007

REASON: The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.

MANUFACTURER: Recalling Firm: Skytron, Div. The KMW Group, Inc, Grand Rapids, MI, by letters on November 23, 1999, November 1, 2002 and again on January 8, 2007. Manufacturer: Dai-Ichi Shomei Co., Ltd. Tokyo, Japan. Firm initiated recall is ongoing.
PRODUCT:
a) Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19" diameter lighthead; Models IN19, IN19EL, IN19LH and IN19S, Recall # Z-0524-2007;
b) Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19" diameter lightheads, Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT, Recall # Z-0525-2007;
c) Skytron Infinity Series surgical light, 4 bulbs in 1 - 22" diameter lighthead, Made in Japan; Models IF54, IF54EL, IF54LH and IF54S, Recall # Z-0526-2007;
d) Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22" diameter lightheads, Made in Japan; Models IF5454 and IF5454EL, Recall # Z-0527-2007;
e) Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22" diameter lightheads, Made in Japan; Models IF545454 and IF545454EL, Recall # Z-0528-2007;
f) Skytron Infinity Series surgical light, 5 bulbs in 1 - 22" diameter lighthead, Made in Japan; Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, IN22LH and IF22(EL), Recall # Z-0529-2007;
g) Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22" diameter lightheads, Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL, Recall # Z-0530-2007;
h) Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22" lighthead and 8 bulbs in 1 - 30" diameter lighthead. Made in Japan; Model IF3022B. (note only the 22' lighthead is affected.), Recall # Z-0531-2007;
i) Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22" diameter lightheads, Made in Japan; Models IF222222-B, IF222222EL and IN222222EL, Recall # Z-0532-2007;
j) Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30" diameter lighthead and 5 bulbs in 1 - 22" diameter lighthead, Made in Japan; Models IN3022EL and IF3022EL. (note only the 22' lighthead is affected), Recall # Z-0533-2007;
k) Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30" diameter lighthead and 5 bulbs in each of 2 - 22" diameter lightheads, Model IN302222EL, IF302222-B, IN30AR2222EL and IN30TV2222EL. (note only the 22' lightheads are affected), Recall # Z-0534-2007

REASON: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated January 30, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; part number 08717741, Recall # Z-0548-2007;
b) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System with a Pinhole Collimator, Recall # Z-0549-2007

REASON: Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.

MANUFACTURER: Steris Corporation, Montgomery, AL, by letter on February 6, 2007. Firm initiated recall is ongoing.

PRODUCT: Cmax Surgical Table, Model No. 2182625, Recall # Z-0554-2007

REASON: A variation in suppliers welding processes, at the inner section of the hydraulic lift column, of the surgical table, may result in the table top becoming unstable, which could result in injury to patients or staff.

CLASS III

MANUFACTURER: Nicolet Biomedical, Div of Viasys Healthcare, Madison, WI, by Advisory Notice, dated August 25, 2006. Firm initiated recall is ongoing.

PRODUCT: NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems, Recall # Z-0380-2007

REASON: A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using the M, and/or C series amplifiers. If this anomaly occurs, the system will display the data for channel one in all channels on NicoletOne LTM, Sleep, nEEG, vEEG or ICU Monitor systems.

MANUFACTURER: Teknimed SA, L, France, by letter dated August 31, 2006 and October 1, 2006. Firm initiated recall is ongoing.

PRODUCT: OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30cc, Recall # Z-0423-2007

REASON: The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box.

MANUFACTURER: Recalling Firm: EMD Chemicals Inc, Gibbstown, NJ, by letter on August 17, 2006. Manufacturer: Merck KGaA, Darmstadt, Germany. Firm Initiated recall is complete.

PRODUCT:
a) Anaerotest for microbiology, in vitro diagnostic. Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Item # 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928, Recall # Z-0498-2007;
b) Anaerotest, in vitro diagnostic; Microbiology, 50 test strips Item # 1.15112.001. Store dry and tightly closed. Store at + 15 C to +25C, Recall # Z-0499-2007

REASON: Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 21, 2007:

CLASS II

MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, by letter on December 8, 2006. Manufacturer: Marson Medical, Inc., Paramus, NJ. Firm initiated recall is ongoing.

PRODUCT: Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Recall # Z-0411-2007

REASON: Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument during use.

MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea CA, by letter on October 27, 2006. Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.

PRODUCT: Access® Immunoassay Systems Thyroglobulin Antibody Reagent Kit, in vitro diagnostic, Part Number 33890, Recall # Z-0417-2007

REASON: Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 14, 2007:

CLASS II

MANUFACTURER: Recalling Firm: Boston Scientific, Maple Grove, MN, by letters dated December 13 and December 14, 2006. Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C Mex, Mexico. Firm initiated recall is ongoing.

PRODUCT:
a) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070', Internal Mammary Curve, UPN # H74934356260, Catalog # 34356-26. Made in Mexico, Recall # Z-0382-2007;
b) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070', Voda Left Curve, UPN # H74934356710, Catalog # 34356-71. Made in Mexico,
Recall # Z-0383-2007;
c) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081', Multipurpose Curve, UPN # H74934357380, Catalog # 34357-38. Made in
Mexico, Recall # Z-0384-2007;
d) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091', Amplatz Right Curve, UPN # H74934358180, Catalog # 34358-18. Made in
Mexico, Recall # Z-0385-2007;
e) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091', Amplatz Left Curve, UPN # H74934358190, Catalog # 34358-19. Made in
Mexico, Recall # Z-0386-2007;
f) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081', Voda Left Curve, UPN # H74934357730, Catalog # 34357-73. Made in Mexico,
Recall # Z-0387-2007;
g) Boston Scientific Mach 1 Peripheral Guide Catheter, 6F, 55cm, LIMA Tip Shape, UPN # M001196620, Catalog # 19-662. Made in Mexico, Recall # Z-0388-2007

REASON: Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin detaching from the device during the procedure.

MANUFACTURER: Recalling Firm: Integrated Orbital Implants Inc., San Diego, CA, by telephone, fax and letter on December 20, 2006. Manufacturer: Kolberg Ocular Products Inc., San Diego, CA. Firm initiated recall is ongoing.

PRODUCT: Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), for use in ocular implants, Model Number 100045 The threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support System. The threaded sleeve is an externally threaded cylinder and an internal drilled hole designed to receive a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K Titanium threaded sleeve wrench after a hole has been prepared in the implant by drilling with a series of hypodermic needles of gradually increasing sizes. After the threaded sleeve is placed in the implant, any of the P-K Pegs can be inserted. The affected model which is the subject of this recall comes with the flat peg. Product is not serialized. Note: Lot code assigned by the contract manufacturing firm, Recall # Z-0396-2007

REASON: The threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. Failure to properly identify the affected components and apply the modified insertion technique will result in an inability to insert the sleeve into the implant.

MANUFACTURER: Belcher Pharmaceuticals, Inc., Largo, FL, by letter dated September 25, 2006. Firm initiated recall is ongoing.

PRODUCT: Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle, Recall # Z-0398-2007

REASON: Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letters on December 8, 2006. Manufacturer: Stryker Orthopaedi, Limerick, Ireland. Firm initiated recall is ongoing.

PRODUCT:
a) Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM, Ref # 5530-G-211 2011-09, Recall # Z-0399-2007;
b) Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #7 - 11MM Ref # 5530-G-711 2011-09, Recall # Z-0400-2007

REASON: A product mix -up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.

MANUFACTURER: BD Opathalmic Systems, Waltham, MA, by letters on December 26, 2006 and January 10, 2007. Firm initiated recall is ongoing.

PRODUCT:
a) BD Beaver™ Mini-Blade, Blade Mini Orthopedic 1.255 in, Catalog Number: 374562, Recall # Z-0401-2007;
b) BD Beaver™ Mini-Blade, Blade Mini Orthopedic 1.31 in, Catalog Number: 376100, Recall # Z-0402-2007;
c) BD Beaver™ Mini-Blade, Blade Sharp Two Sides Pointed, Catalog Number: 376300, Recall # Z-0403-2007;
d) BD Beaver™ Mini-Blade, Blade Mini RND Tip Sharp One Side, Catalog Number: 376400, Recall # Z-0404-2007;
e) BD Beaver™ Mini-Blade, Blade Mini Pointed Tip S/SU, Catalog Number: 376500, Recall # Z-0405-2007;
f) BD Beaver™ Mini-Blade, Blade Mini Curved Sharp on One, Catalog Number: 376700, Recall # Z-0406-2007;
g) BD Beaver™ Mini-Blade, Blade Mini Sharp All Around S/SU, Catalog Number: 376900, Recall # Z-0407-2007;
h) BD Beaver™ Mini-Blade, Mini/Bulk 64, Catalog Number: 374820, Recall # Z-0408-2007;
i) BD Beaver™ Mini-Blade, Mini/Bulk 67, Catalog Number: 374822, Recall # Z-0409-2007;
j) BD Beaver™ Mini-Blade, Mini/Bulk 69, Catalog Number: 374823, Recall # Z-0410-2007

REASON: Product sterility may be compromised due to incomplete package seal.

MANUFACTURER: Ascent Healthcare Solutions, Inc., Lakeland, FL, by facsimile letter on October 19, 2006. Firm initiated recall is ongoing.

PRODUCT: AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length, Recall # Z-0414-2007

REASON: The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by telephone and fax beginning December 13, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller Board Part #78560-109; Recall # Z-0415-2007;
b) ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; Temperature Controller Board Part #78560-109; Recall # Z-0416-2007

REASON: The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stopping temperature control function of the board. Situation does not stop analyzer operation and does not generate an error condition alerting operator when condition occurs.

MANUFACTURER: Recalling Firm: Beckman Coulter Inc, Brea, CA, by letter beginning August 29, 2006. Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is ongoing.

PRODUCT:
a) Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User; Part #723113 Software Kit; CXP version 2.1 Upgrade; Part #629637 Software Kit; CXP version 2.0 New User; Part #629636 Software Kit; CXP version 2.0 Upgrade. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles, Recall # Z-0418-2007;
b( Cytomics FC 500 MPL with MXP software, Versions 2.0 & 2.1: Part #731419 KIT; FOC MXP 2.0 UPGRADE KIT; Part #731418 SWRE KIT; MXP 2.0 NEW USER; Part #772145 MXP 2.1 FOC Upgrade Kit; 771938 MXP 2.1 Software; Part #771952 FOC MXP 2.1 Upgrade Kit; Part #771953 New User MXP 2.1 Kit. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles, Recall # Z-0419-2007;
c) CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part #722395 CXP Analysis Software Kit V2.1, Single User Upgrade; Part #722397 CXP Analysis Software Kit V2.1, 3 User Pack; Part #722398 CXP Analysis Software Kit V2.1, 5 User Pack; Part #722399 CXP Analysis Software Kit V2. 1, 15 User Pack; Part # 722593 CXP Analysis Software Kit V2.1, 5 Network User Pack Part #722594 CXP Analysis Software Kit V2.1, 10 Network User Pack; Part #722595 CXP Analysis Software Kit V2.1, 15 Network User Pack; Part #629640 CXP Analysis Software Kit V2.0, Single User; Part #629639 CXP Analysis Software Kit V2.0, Single User Upgrade; Part #629641 CXP Analysis Software Kit V2.0, 3 User Pack; Part #629642 CXP Analysis Software Kit V2.0, 5 User Pack; Part #629643 CXP Analysis Software Kit V2.0, 15 User Pack; Part #629644 CXP Analysis Software Kit V2.0, 5 Network User Pack; Part #629645 CXP Analysis Software Kit V2.0, 10 Network User Pack; Part #629646 CXP Analysis
Software Kit V2.0, 15 Network User Pack. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles, Recall # Z-0420-2007

REASON: Two workflow scenarios associated with renaming regions may produce incorrect results.

MANUFACTURER: Phillips Ultrasound, Inc., Bothell, WA, by letter dated October 31, 2006. Firm initiated recall is ongoing.

PRODUCT: iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic), Recall # Z-0422-2007

REASON: Acoustic output intensity may exceed maximum specified limits and the patient contact temperature may exceed 43 degree C (when the system is used with the S12-4 transducer in CW-mode)

CLASS III

MANUFACTURER: Recalling Firm: Elekta, Inc. Norcross GA, by letter dated November 23, 2006. Manufacturer: Elekta Oncology, Sussex, UK. Firm initiated recall is ongoing.

PRODUCT: Desktop Pro™ R6.0 & R6.1, Linear Medical Accelerator, Model number MRT 9871/ MRT 10601, Recall # Z-0421-2007

REASON: Unexpected Diaphragm movement when manual field size modifications are not saved.
 

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 7, 2007:

CLASS II

MANUFACTURER: Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Cranston, RI, by letter on December 27, 2006. Manufacturer: Bard Shannon Limited, Humacao, PR. Firm initiated recall is ongoing.

PRODUCT:
a) Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the abdominal wall. Reference Number 0113036 or 9113036 (refurbished), Recall # Z-0374-2007;
b) Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. Reference Number 0113037 or 9113037(refurbished), Recall # Z-0375-2007

REASON: Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing.

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone, fax, email or by visit between November 8, 2006 and November 13, 2006. Firm initiated recall is complete.

PRODUCT: Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046, Recall # Z-0381-2007

REASON: Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and caused the pump to stop during clinical use and a ''connect motor'' message to be displayed.

MANUFACTURER: Abbott Vascular-Cardiac Therapies dba Guidant Corp., Temecula, CA, by letter on December 5, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter – Reference Number 23242, Recall # Z-0390-2007;
b) ACS DUOSTAT® Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23244, Recall # Z-0391-2007

REASON: Specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch.

MANUFACTURER: Bard Peripheral Vascular, Inc., Tempe, AZ, by letters on December 20, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-320J, Recall # Z-0393-2007;
b) Recovery G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-220J ***For Canada & Australia only***, Recall # Z-0394-2007

REASON: This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity.

MANUFACTURER: Boston Scientific Target, Fremont, CA, by letter on December 1, 2006. Firm initiated recall is ongoing.

PRODUCT: Boston Scientific brand iLab™ Ultrasound Imaging System, for intravascular use; Model Number(s): iLab120lNS, iLab2401NS, Recall # Z-0395-2007

REASON: The product fails to comply with applicable electronic product performance standard, in that the electromagnetic energy is in excess of the labeled conformance standards for radiated emissions.

MANUFACTURER: Rhytec, Inc., Waltham, MA, by letter dated October 2, 2006. Firm initiated recall is ongoing.

PRODUCT: Portrait® PSR3 System, an electro-surgical device used in dermatological applications, Recall # Z-0397-2007

REASON: Inadequate Directions for Use: Software Upgrade to set maximum pulse rate to 2.5 Hz.

CLASS III

MANUFACTURER: Ev3, Inc., Plymouth, MN, by letter on December 6, 2006. Firm initiated recall is complete.

PRODUCT: ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120, Recall # Z-0389-2007

REASON: Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected.
 

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 31, 2007:

CLASS II

MANUFACTURER: Cyberonics, Inc., Houston, TX, by safety alert on November 14, 2006. Firm initiated recall is onging.

PRODUCT: a) Cyberonics VNS Therapy System, Model 250-'HAND HELD' programming software v6.1, v6.1.7, v7.0 and v7.1.3, Recall # Z-0341-2007;
b) Handhelds-Cyberonics VNS Therapy System, Model 2500-'Handhelds' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3, Recall # Z-0342-2007

REASON: During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician

MANUFACTURER: Recalling Firm: Maquet, Inc., Bridgewater, NJ, by visit on December 11, 2006. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.

PRODUCT: Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machin, Article number: 0704629, Recall # Z-0350-2007

REASON: The HCU 30 system potentially will not be have the power capacity to run the compressor when the heaters are on during operation. This may lead to a situation where the user may not be able to cool the patient and/or cardioplegia sufficiently.

MANUFACTURER: Diagnostic Chemicals, Ltd., Charlottetown Prince Edward Island, Canada, by letter dated December 5, 2006. Firm initiated recall is ongoing

PRODUCT: Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Recall # Z-0361-2007

REASON: Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end users, DCL cannot be certain which instruments the end users employ in their laboratories.

MANUFACTURER: Suros Surgical Systems, Inc., Indianapolis, IN, by telephone beginning on December 15, 2006 and follow-up letter dated December 19, 2006. Firm initiated recall is ongoing.

PRODUCT: Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile, Part no. 0912-20, Recall # Z-0362-2007

REASON: The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.

MANUFACTURER: Recalling Firm: Bock, Otto, Orthopedic Ind., Inc., Minneapolis MN, by letter dated August 11, 2006. Manufacturer: Otto Bock Austria, Wien, Austria. Firm initiated recall is ongoing.

PRODUCT: Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees, Recall # Z-0363-2007

REASON: A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed to strong vibrations these Compact knee joints have an increased probability of malfunction and a resultant risk to the Compact wearer.

MANUFACTURER: Recalling Firm: Abbott Point of Care Inc., East Windsor NJ, by letter on December 13, 2006. Manufacturer: Abbott Point Of Care I Stat, Kanatakanata Ontario, Canada. Firm initiated recall is ongoing.

PRODUCT: i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Product list #’s 04J50-01 and 04J50-02, catalog # 420200; Ref 04J50-01 24, Recall # Z-0364-2007

REASON: Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges.

MANUFACTURER: Terang Nusa Sdn Bhd, Kota Bharu, Malaysia, by telephone on December 13, 2006 and by letter dated December 20, 2006. Firm initiated recall is ongoing.

PRODUCT: Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Item number MDS207060, Recall # Z-0365-2007

REASON: Some of the packages labeled as latex-free actually contain latex gloves.

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Philips, Bothell, WA, by letter dated December 12, 2006. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.

PRODUCT:
a) Philips Integris Allura x-ray systems angiographic - Allura 9 F/C (floor and ceiling models). A mono-plane analog Allura with a 9" Image Intensifier, Recall # Z-0366-2007;
b) Allura Mono X-Ray System, angiographic - monoplane, analog Allura with a 12" and 15" Image Intensifier, Recall # Z-0367-2007,
c) Allura FD 10 FC, X-Ray System, angiographic - a monoplane, digital Allura FD (flat detector) with a 10" Image Intensifier (II), Recall # Z-0368-2007;
d) Allura FD20 x-ray system, angiograph, monoplane, digital Allura FD with a 20" detector FD, Recall # Z-0369-2007;
e) FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10" detector, Recall # Z-0370-2007;
f) FD 20/10 X-Ray System, Angiograph, biplane, digital Allura FD, 10" and 20" detectors, Recall # Z-0371-2007

REASON: Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.

MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated January 12, 2007. Firm initiated recall is ongoing.

PRODUCT: GE Centricity PACS RA 1000 Workstation; for diagnostic image analysis; Software versions 2.1.XX. and 3.0.XX. used in combination with the GE Senographe 2000D, Senographe DS or Senographe Essential, Recall # Z-0373-2007

REASON: The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential.

MANUFACTURER: Bio-Rad Laboratories, Inc., Hercules, CA, by

PRODUCT: BIo-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits, Recall # Z-0376-2007

REASON: The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.

MANUFACTURER: Cook Urological, Inc., Spencer, IN, by letter dated January 5, 2007. Firm initiated recall is ongoing.

PRODUCT: Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL, Recall # Z-0377-2007

REASON: Lack of assurance of sterility, as the packages may not have been sealed.

CLASS III

MANUFACTURER: Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by letter dated September 6, 2006. Manufacturer: Medtronic Mexico, S. De R. L. De C. V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.

PRODUCT: Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack is the responsibility of the user. The tubing is made of polyvinyl chloride (PVC). Portions of the tapered tubing are used in the vent, suction and arterial roller heads of the heart lung machine, Recall # Z-0340-7

REASON: An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.

MANUFACTURER: Smiths Medical ASD, Inc., Gary, IN, by letter dated December 15, 2006. Firm initiated recall is ongoing.

PRODUCT: Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, REF BOSL1L, Recall # Z-0378-2007

REASON: The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of January 24, 2007

CLASS II

MANUFACTURER
Recalling Firm: Rymed Technologies, Inc., Austin TX, by e-mail and/or phone on May 25, 2006. Manufacturer: Accelent Juarez, Juarez, Mexico. Firm initiated recall is complete.

PRODUCT:
a) RYM-5000 InVision-Plus® Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico, Recall # Z-0319-2007;
b) RYM-5000 InVision-Plus® NEUTRAL™ I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico, Recall # Z-0320-2007;
c) RYM-5001 InVision-Plus® Neutral Displacement I.V. Connector, packaged 100 units per box, 5 boxes per case (500 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico, Recall # Z-0321-2007

REASON: Weld failures on IV connector (area of female luer and spike body)

MANUFACTURER: MRL, Inc., A Welch Allyn Co., Buffalo Grove, IL, by letters dated November 8, 2006. Firm initiated recall is ongoing.

PRODUCT: Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator; a portable 12V internal battery powered defibrillator; Part Numbers-971081, 971082, 971083, 971084, Recall # Z-0343-2007

REASON: Shock Delay:The monitor-debrillator may display an 'ECG Comm' error message on the display during use,which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. This delay could result in failure to resuscitate the patient.

MANUFACTURER: Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY, by letters on September 8, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this 'field correction': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline, Recall # Z-0351-2007;
b) ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer – human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this 'field correction': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline, Recall # Z-0352-2007;
c) ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer – human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this 'field correction': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline, Recall # Z-0353-2007

REASON: Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%.

MANUFACTURER: Recalling Firm: Abbott Spine, Austin, TX, by telephone on November 7, 2006. Manufacturer: Phillips Precision, Inc., Elmwood Park, NJ. Firm initiated recall is ongoing.

PRODUCT:
a) TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system, Part #2665-1-07 (7mm), 2665-1-09 (9mm), 2665-1-11 (11mm), 2665-1-13 (13mm), 2665-1-15 (15mm), Recall # Z-0354-2007;
b) TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral body replacement system Part #2664-1-07 (7mm), 2664-1-09 (9mm), 2664-1-11 (11mm), 2664-1-13 (13mm), 2664-1-15 (15mm), Recall # Z-0355-2007

REASON: Tip of devices may dislodge while in use during surgery.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letters dated December 15, 2006. Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.

PRODUCT: Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic, Recall # Z-0356-2007

REASON: Falsely elevated IGGT results may be reported because the R2 reagent of the Tina-quant Gen.2 albumin assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay when used on the COBAS INTEGRA 700 and 800 analyzers.

MANUFACTURER: Continental Medical Labs,Inc., Waterford, WI, by letter on October 19, 2006. Firm initiated recall is ongoing.

PRODUCT: Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device; Catalogue #364902 as a finished sterile device, Non Pyrogenic in unopened undamaged package, Disposable/ Single use/ Do Not Reuse; for use with multi lumen; (4 Venous Catheter sizes) 20 cm. 12 fr. Central; 16 cm. 7-7.5-8 fr. Central; 20 cm 7.7.5-8 fr Central; 16cm 12 fr. Central, Recall # Z-0357-2007

REASON: Fibrin Analysis Catheter Testing System contains the ''Luer Lok Access Device'' that fails to lock securely to certain catheter devices because the male luer taper surface is not within the specification of the taper.

MANUFACTURER: I-Flow Corp., Lake Forest, CA, by faxed letter on November 29, 2006. Firm initiated recall is ongoing.

PRODUCT: I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Recall # Z-0358-2007

REASON: The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling.

MANUFACTURER: Recalling Firm: Embeem, Inc., N. Brunswick, NJ, by letters November 9, 2006. Manufacturer: ABS Medicare Pvt. Ltd, Gujarat, India. Firm initiated recall is ongoing.

PRODUCT: HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4', 2.4 x 4.7', & 4.7 x 4.7'. Product is a transparent, flexible sheet. Packaged in a peelable pouch, Recall # Z-0455-2007

REASON: Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material

CLASS III

MANUFACTURER: Recalling Firm: OrthoHelix Surgical Designs, Inc., Akron, OH, by telephone on August 3, 2006. Manufacturer: Specialized Medical Devices, Lancaster, PA. Firm initiated recall is ongoing.

PRODUCT: DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS: 6 stainless steel plates (2-lefts, 2-rights, and 1-right long and 1-right left), 48 distal locking-screws (ranging from 10-24mm), 32 distal locking pegs, 36 proximal locking screws, 24 proximal non-locking screws. INSTRUMENTS: 2 Bending Pliers*, 1 Bone Reduction Forcep*, 2 Hohmann Retractors *, 1 Ratchet Handle*, 1 Periosteal Elevator*, 1 Dingman Elevator *, 1 K & K Elevator *, four Driver tips *, five drill guides*, 2-1.6 Drill Bits *, 2-2.3 Drill Bits *, 1 Plate Holder Verbruge *, 2 Depth Gages *, 6 K wires, Recall # Z-0349-2007

REASON: The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of January 17, 2007

CLASS I

MANUFACTURER: Core Care Technologies, Inc., Swell, NJ, by telephone and letter on November 21, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) One Touch Basic/Profile and b) One Touch Ultra- Blood Glucose Test Strips, Recall # Z-0266-2007 Code Information:

REASON: Counterfeit product.

CLASS II

MANUFACTURER: Advanced Bionics Corp., Sylmar, CA, by letters on September 21, 2006. Firm initiated recall is ongoing.

PRODUCT: Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70, Recall # Z-0299-2007

REASON: A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.

MANUFACTURER: Edwards LifeSciences Corp., of Puerto Rico, Anasco, PR, by voice mail on November 2, 2006. Firm initiated recall is ongoing.

PRODUCT: Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S, Recall # Z-0318--2007

REASON: Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.

MANUFACTURER: Recalling Firm: Southern Prosthetic Supply Co., Alpharetta, GA, by letters on October 6 and October 10, 2006. Manufacturer: Medi Bayreuth, Bayreuth, Bavaria, Germany. Firm initiated recall is ongoing.

PRODUCT: SPS Blue Line Tube Clamp Adapters, Product number BL120M, Recall # Z-0445-2007

REASON: Device Fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail.

MANUFACTURER: Respironics, Inc., Murrysville, PA, by letter dated October 25, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) REMstar Heated Humidifier (Respiratory Gas Humidifier) Model numbers: 1005792, U1005792, R1005792, SC1005792, AC1005792, and 1007861, Recall # Z-0446-2007;
b) REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265, Recall # Z-0447-2007

REASON: AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device.

MANUFACTURER: Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by email on 11/15/06 and letter. Manufacturer Firm: DePuy Ireland Ltd., Cork, Ireland. Firm initiated recall is ongoing.

PRODUCT:
a) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 1, sterile; Part number 1498-24-001, Recall # Z-0456-2007;
b) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left Lateral, Size 1, sterile; Part number 1498-23-001, Recall # Z-0457-2007;
c) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 2, sterile; Part number 1498-24-002, Recall # Z-0458-2007;
d) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left Lateral, Size 2, sterile; Part number 1498-23-002, Recall # Z-0459-2007;
e) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 3, sterile; Part number 1498-24-003, Recall # Z-0460-2007;
f) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left Lateral, Size 3, sterile; Part number 1498-23-003, Recall # Z-0461-2007;
g) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 4, sterile; Part number 1498-24-004, Recall # Z-0462-2007;
h) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left Lateral, Size 4, sterile; Part number 1498-23-004, Recall # Z-0463-2007;
i) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 5, sterile;Part number 1498-24-005, Recall # Z-0464-2007;
j) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/left Lateral, Size 5, sterile; Part number 1498-23-005, Recall # Z-0465-2007

REASON: Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., MahwahNJ., by letter on November 7, 2006. Manufacturer: Stryker, Limerick, Ireland. Firm initiated recall is ongoing.

PRODUCT: Simplex P with Tobramycin. Antibiotic PMMA Bone Cement, Recall # Z-0467-2007

REASON: The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will support. The expiration date on the external package states December 2007 and the expiration date of the liquid monomer is September 2006.

MANUFACTURER: Recalling Firm: Ossur, Reykjavik, Iceland, by letter on November 9th, 2006. Manufacturer: Ossur North America Inc., Aliso Viejo, CA. Firm initiated recall is ongoing.
PRODUCT: Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007, Recall # Z-0468-2007
REASON: Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on November 29, 2006. Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, Ireland. Firm initiated recall is ongoing.

PRODUCT:
a) Howmedica Hip Fracture Stem System, Product Number: 6942-0-10,No. 1 Femoral Component, Fenestrated Sterile Made in Ireland, Recall # Z-0472-2007;
b) Howmedica Hip Fracture Stem System No. 2 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-020 Made in Ireland, Recall # Z-0473-2007;
c) Howmedica Hip Fracture Stem System No. 3 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-030 Made in Ireland, Recall # Z-0474-2007;
d) Howmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated Plus Sterile REF Catalogue #6942-0-035 Made in Ireland, Recall # Z-0475-2007;
e) Howmedica Hip Fracture Stem System No. 4 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-040 Made in Ireland, Recall # Z-0476-2007

REASON: Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.

MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle, IL, by letter dated August 31, 2006. Manufacturer: Arjo Med. AB, Gloucester, UK. Firm initiated recall is ongoing.

PRODUCT: Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; model number HMB002-US, Recall # Z-0478-2007

REASON: The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt.

MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle, IL, by letters on October 30, 2006. Manufacturer: B. H. M. Medical, Inc., Magog Quebec, Canada. Firm initiated recall is ongoing.

PRODUCT: BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift. The fixed gate, part #700.11550, was sold in two kits:
a) Part #700.11500 Kwiktrak Gate Kit composed of the fixed gate and a 3-contact interface kit part #700.15515, and
b) Part #700-11505 Double Gate Kit composed of two fixed gates and 3-contact interface kits, Recall # Z-0479-2007

REASON: The Kwiktrak Gate stopper may fail and allow the ceiling lift to pass through to the end of the track and fail to the floor.

MANUFACTURER: Viasys Respiratory Care, Inc., Palm Springs, CA., by letters on November 2, 2006 and November 4, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653, Recall # Z-0480-2007;
b) Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654, Recall # Z-0481-2007

REASON: The correction is due to a repeat “failure to cycle” event.

MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle, IL, by letters on November 13, 2006. Manufacturer: B. H. M. Medical, Inc., Magog Quebec, Canada. Firm initiated recall is ongoing.

PRODUCT: BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley. The reacher comes in two models: part #700.08310 - 24' handle length, and part #700.08320 - 36' handle length, Recall # Z-0482-2007

REASON: The carabineer may not be correctly attached to the reacher and the portable patient lift may drop.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter on December 6, 2006. Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.

PRODUCT:
a) Baxter Colleague Single Channel Volumetric Infusion Pumps; Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R, Recall # Z-0483-2007;
b) Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore; product codes 2M8153, 2M8153R, 2M8163, 2M8163R, Recall # 0484-2007

REASON: Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user.

MANUFACTURER: Recalling Firm: Varian Medical Systems, Charlottesville, VA, by e-mail and letter on September 11, 2006. Manufacturer: Varian Medical Systems Haan, Haan, Federal Republic of Germany.

PRODUCT: a) GammaMed 12i radionuclide applicator systems, Recall # Z-0486-2007; b) GammaMed 12it radionuclide applicator system, Recall # Z-0487-2007

REASON: Medical device for patient treatment does not meet electrical safety standards.

MANUFACTURER: Abbott Laboratories MPG, Abbott Park, IL, by letter dated November 22, 2006. Firm initiated recall is ongoing.

PRODUCT: ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 (4 x 500 tests), Recall # Z-0488-2007

REASON: The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that are elevated. Correlation studies have demonstrated an upward shift in slope for patient results of approximately 13% on average when compared to other currently available reagent lots and an average bias from patient specimens of 13% to 17% has been observed.

CLASS III

MANUFACTURER: International Technidyne Corp., Edison, NJ, by letter, on December 6, 2006. Firm initiated recall is ongoing.

PRODUCT: International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Protimepro, Protimeintrf & Protimeprorf, Protimeintl & Protimeprol, Recall # Z-0470-2007

REASON: Incorrect Test Results-ProTime ITC's Microcoagulation System: Professional Instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the AUTO Send or PRINT RESULTS feature.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of January 10, 2007

CLASS I

MANUFACTURER: Core Care Technologies, Inc., Sewell NJ, by telephone beginning on October 14, 2006 and by letter on November 21, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) One Touch Basic/Profile and
b) One Touch Ultra- Blood Glucose Test Strips, Recall # Z-0266-2007

REASON: Counterfeit product.

CLASS II

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters on October 12, 2006 and December 11, 2006.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.

PRODUCT:
Allura X-per FD 10/10 x-ray, and fluoroscopy, Recall # Z-0165-2007;
b) Allura Xper FD 20/10 x-ray, and fluoroscopy, Recall # Z-0166-2007

REASON: Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by in-house servicing on October 6, 2005 and October 18, 2006. Firm initiated recall is complete.

PRODUCT:
a) Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041, Recall # Z-0292-2007;
b) Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040, Recall # Z-0293-2007

REASON:
a) Six inch roller pumps were mislabeled as 4 inch roller pumps;
b) An incorrect serial number was placed on one roller pump

MANUFACTURER: Phillips Medical Systems, Seattle, WA, by letters on December 19, 2006. Firm initiated recall is ongoing.
PRODUCT: HeartStart FR2+ Defibrillator, Recall # Z-0308-2007
REASON: Potential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation.

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, sent an addendum to the operators manual on October 12, 2004 and December 15, 2004. Firm initiated recall is ongoing.

PRODUCT:
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763, Recall # Z-0322-2007;
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States), Recall # Z-0323-2007;
c) Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040, Recall # Z-0324-2007;
d) Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041, Recall # Z-0325-2007;
e) Terumo Advanced Perfusion System 1 Air Bubble Detection Module; Catalog number 802110,
Recall # Z-0326-2007;
f) Terumo Advanced Perfusion System 1 Data Interface CDI 100; Catalog number 802558, Recall # Z-0327-2007;
g) Terumo Advanced Perfusion System 1 Data Interface CDI 500; Catalog number 803479, Recall # Z-0328-2007;
h) Terumo Advanced Perfusion System 1 Venous Occluder; Catalog number 803480, Recall # Z-0329-2007;
i) Terumo Advanced Perfusion System 1 Level Detection; Catalog number 802111, Recall # Z-0330-2007;
j) Terumo Advanced Perfusion System 1 Pressure Monitoring; Catalog number 802112; Recall # Z-0331-2007;
k) Terumo Advanced Perfusion System 1 Temperature Monitoring System; Catalog number 802114; Recall # Z-0332-2007;
l) Terumo Advanced Perfusion System 1 Flow Module; Catalog number 802018, Recall # Z-0333-2007;
m) Terumo Advanced Perfusion System 1 Data Interface RS 485; Catalog number 803518, Recall # Z-0334-2007;
n) Terumo Advanced Perfusion System 1 Control Unit; Catalog number 801046, Recall # Z-0335-2007;
o) Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188,
Recall # Z-0336-2007
p) Advanced Perfusion System 1 Central Control Monitor; Catalog number 802100, Recall # Z-0337-2007

REASON: Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.

MANUFACTURER Edwards LifeSciences Technology SAEL, Anasco, PR, by letter on November 28, 2006. Firm initiated recall is ongoing.

PRODUCT: Product Description: Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75, Model Number: 831FH75, Recall # Z-0338-2007

REASON: Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating).

MANUFACTURER: Smiths Medical ASD, Inc., Gary, IN, by letter dated August 25, 2006. Firm initiated recall is ongoing.

PRODUCT: Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185, Recall # Z-0339-2007

REASON: Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.

MANUFACTURER: Recalling Firm: Smith & Nephew, Inc., Endoscopy Division, Andover, MA, by letter on September 29, 2006. Manufacturer: OsteoBiologics, Inc., San Antonio, TX. Firm initiated recall is ongoing.

PRODUCT:
a) TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as sterile;
Recall # Z-0440-2007;
b)TruFit CB Plug Size Code Blue, 9mm; quantity 1; Part #605-001-05; product labeled as sterile;
Recall # Z-0441-2007;
c) TruFit BGS Plug Size Code Red, 7mm; quantity 1; Part #600-001-03; product labeled as sterile;
Recall # Z-0442-2007;
d) TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; product labeled as sterile;
Recall # Z-0443-2007

REASON: Mis-packaging. Product in the package may be a different size than indicated on the labeling.
 

MANUFACTURER: Recalling Firm: Puritan Bennett Corporation, Carlsbad, CA, by letter on August 31, 2006. Manufacturer: Nellcor Puritan Bennett Ireland, Galway, Ireland. Firm initiated recall is ongoing.

PRODUCT: Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD, Recall # Z-0444-2007

REASON: Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.

MANUFACTURER: Drew Scientific, Inc., Oxford, CT., by letter on August 24, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) Bayer Advia 70 Hematology Analyzer, Recall # Z-0448-2007;
b) Drew Excell 22 Hematology Analyzer, Recall # Z-0449-2007

REASON: Flags and alerts on the user interface will not automatically transfer to the LIS.

MANUFACTURER: Drew Scientific, Inc., Oxford, CT., by letter on September 20, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) Bayer Advia 70 Hematology Analyzer, Recall # Z-0450-2007;
b) Drew Excell 22 Hematology Analyzer, Recall # Z-0451-2007

REASON: System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platelet counts.

MANUFACTURER: LifeScan, Inc., Milpitas, CA, by letter on September 29, 2006 and posted the notice on the website. Firm initiated recall is ongoing.

PRODUCT:
a) LifeScan brand One Touch Sure Step-Blood Glucose Monitoring System Test Strips, 50 strips per package, part number: 020-052-01, Recall # Z-0452-2007;
b) LifeScan brand One Touch Sure Step Pro-Blood Glucose Monitoring System Test Strips, 50 strips per package, part number: 010-797-02, Recall # Z-0453-2007

REASON: Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.

MANUFACTURER: Recalling Firm: Abbott Laboratories, Inc., South Pasadena, CA, by letters on September 26, 2006. Manufacturer: Dade Behring, Inc., Cupertino, CA. Firm initiated recall is ongoing.

PRODUCT: Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division, Recall # Z-0454-2007

REASON: Erratic elevated results and or the inability to calibrate due to imprecision.

MANUFACTURER: Recalling Firm: Integra LifeSciences, Corp., Plainsboro, NJ, by letter, telephone and e-mail on November 10, 2006. Manufacturer: NewDeal SA, Lyon, France. Firm initiated recall is ongoing.

PRODUCT: BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment. Model/Catalog number: 159004ND, Recall # Z-0466-2007

REASON: Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.

MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on November 1, 2006. Manufacturer: Applied Cytometry, Sheffied, UK. Firm initiated recall is ongoing.

PRODUCT: Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers, Recall # Z-0471-2007

REASON: The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. This issue is limited to only protocols utilizing the Ratio parameter.

CLASS III

MANUFACTURER: Recalling Firm: Rymed Technologies, Inc., Austin, TX, by email and telephone on May 25, 2006. Manufacturer: Accelent Juarez, Juarez, Mexico. Firm initiated recall is ongoing.

PRODUCT:
a) RYM-5000 InVision-Plus® Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico, Recall # Z-0319-2007;
b) RYM-5000 InVision-Plus® NEUTRAL™ I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); abeled as Sterile-Nonpyrogenic; assembled in Mexico, Recall # Z-0320-2007;
c) RYM-5001 InVision-Plus® Neutral Displacement I.V. Connector, packaged 100 units per box, 5 boxes per case (500 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico, Recall # Z-0320-2007

REASON: Weld failures on IV connector (area of female luer and spike body).

MANUFACTURER: Mizuho USA, Inc., Poway, CA, by telephone on November 14, 2006 and by letters on November 21, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, UPC Code 3-02340-30136-7, Product Code 30136; Confirm Clearly Starter Kits: When sold in the U.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the product consists of a reader and one disposable test stick;
b) Confirm Clearly Refills Kits, UPC Code 3-02340-30138-1, Product Code 30138) Note: Confirm Clearly Refills Kits: The refill consists of three disposable test sticks;
c) Special Pack Deal (6 Starter Kits & 6 Refill Kits), Recall # Z-0469-2007

REASON: False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of January 3, 2007

CLASS I

MANUFACTURER: Recalling Firm: Royal Global Wholesale, Boynton Beach, FL, by telephone and letter on November 3, 2006. Manufacturer: Unknown, Milpitas, CA. Firm initiated recall is ongoing.

PRODUCT:
a) OneTouch Ultra- Blood Glucose test strips. For use with One Touch Brand Meters blood glucose meters, Recall # Z-0264-2007;
b) OneTouch Basic/Profile Blood Glucose test strips. For use with One Touch Brand Meters blood glucose meters, Recall # Z-0265-2007

REASON: Counterfeit Glucose Test Strips

CLASS II

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated November 10, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763, Recall # Z-0306-2007;
b) Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only), Recall # Z-0307-2007

REASON: Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.

MANUFACTURER: Endologix Inc., Irvine, CA, by telephone on November 8, 2006 and by letters on November 9, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL, Recall # Z-0309-2007;
b) Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL, Recall # Z-0310-2007

REASON: Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair.

MANUFACTURER: Stardental Division, Lancaster PA, by letters on December 6, 2006. Firm initiated recall is ongoing.

PRODUCT: Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900, Recall # Z-0313-2007

REASON: End cap component can disassemble.

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by visits between May 2004 and November 2005. Firm initiated recall is ongoing.

PRODUCT:
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763, Recall # Z-0314-2007;
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States), Recall # Z-0315-2007

REASON: The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.

MANUFACTURER: Recalling Firm: Whiteside Biomechanics, St. Louis, MO, by telephone on September 15, 2006. Manufacturer: Friedrich Daniels, Solingen, Germany. Firm initiated recall is ongoing.

PRODUCT: Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and Posterior Acetabular Retractor-Right with Light Cord Bracket, Model #BIO-1-1051-A, packaged 1 retractor (left or right retractor) per plastic bag, Recall # Z-0316-2007

REASON: The soft tissue pin in the retractor can break off and become embedded in the tissue.

MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on Oct 17, 2006. Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is ongoing.

PRODUCT: FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit, Recall # Z-0317-2007

REASON: The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such as LeukoSure and DNA Cell Cycle.

CLASS III

MANUFACTURER: EMD Chemicals Inc., Gibbstown NJ, by letter on July 27, 2006. Firm initiated recall is complete.

PRODUCT: Histochemical PAS (Periodic Acid Schiff) Reaction Set. Class I medical device. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests, Item Number 64945/93, Recall # Z-0305-2007

REASON: Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly.

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor MI, by visits between May 2004 and November 2005. Firm initiated recall is ongoing.

PRODUCT:
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763, Recall # Z-0311-2007;
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States), Recall # Z-0312-2007

REASON: The battery status light on the front panel may not accurately reflect the actual status of the battery. The battery may contain more charge than indicated.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 27, 2006

CLASS I

MANUFACTURER: Medical Plastics Devices Inc, Point Claire, Quebec, Canada, by telephone on October 17, 2006 and by letter on October 18, 2006. Firm initiated recall is ongoing.

PRODUCT: a) One Touch Basic/Profile Blood Glucose test strips, Recall # Z-0261-2007; b) One Touch Ultra Blood Glucose Test Strips, Recall # Z-0262-2007

REASON: Counterfeit Glucose Test Strips.

MANUFACTURER: Milwaukee Notions, Inc., Union Grove, WI, by telephone beginning October 10, 2006. Firm initiated recall is ongoing.

PRODUCT: OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE TOUCH Brand Meters, Recall # Z-0263-2007

REASON: Counterfeit

CLASS II

MANUFACTURER: AGA Medical Corporation, Golden Valley MN, by facsimile or e-mail dated September 29, 2006. Firm initiated recall is ongoing

PRODUCT: Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delivery System, Order no. 9-DEL-5F-180/60, 9-DEL-6F-45/60, 9-DEL-6F-180/80, 9-DEL-7F-45/60, 9-DEL-7F-45/80, 9-DEL-7F-180/80, 9-DEL-8F-45/60, 9-DEL-8F-45/80, 9-DEL-8F-180/80, 9-DEL-9F-45/80, 9-DEL-9F-180/80, 9-DEL-10F-45/80, 9-DEL-12F-45/80. [Breakdown of order no. '9-DEL-5F-180/60' is as follows: 9-DEL, French size (5F) - degree angle curve (180) / usable length in cm (60).] b) the following devices are not approved for US distribution: AMPLATZER TorqVue Delivery System, order no. 9-ITV06F45/60, 9-ITV07F45/60, 9-ITV07F45/80, 9-ITV08F45/60, 9-ITV08F45/80, 9-ITV09F45/80, 9-ITV10F45/80, 9-ITV12F45/80, 9-ITV05F180/60, 9-ITV06F180/80, 9-ITV07F180/80, 9-ITV08F180/80, 9-ITV09F180/80. The Delivery System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise, Recall # Z-0255-2007; Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows: a) AMPLATZER Exchange System, Order no. 9-EXCH-6F-180/80, 9-EXCH-8F-180/80, 9EXCH-9F-45/80, 9-EXCH-12F-45/80. [Breakdown of order no. '9-EXCH-6F180/80' is as follows: 9-EXCH, French size (6F) - degree angle curve (180) / usable length in cm (80).] and b) the following devices are not approved for US distribution: AMPLATZER TorqVue Exchange System, Order no. 9-EITV09F45/80, 9-EITV12F45/80, 9-EITV06F180/80, 9-EITV08F180/80. The Exchange System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0256-2007; AMPLATZER TorqVue (cardiac septal occluder) Delivery System with Pusher Catheter Order no. 9-TVSP7F-180/80, 9-TVSP8F-180/80, 9-TVSP9F-180/80. [Breakdown of order no. '9-TVSP-7F-180/80' is as follows: 9-TVSP, French size (7F) - degree angle curve (180) / usable length in cm (80).] Sterile EO. Single Use Only. CAUTION: Investigational device limited by U.S. Law to Investigational Use. The AMPLATZER TorqVue Delivery System with Pusher Catheter consists of a radiopaque delivery sheath, translucent loading device, dilator, plastic vise, delivery cable, and pusher catheter. The delivery system also includes a high pressure Hemostasis valve with a swivel luer connector. The loading device, also with a full thread swivel luer connector, allows a positive fit and seal between sheath and loader. The translucent loader allows for visualization of the device and potentially the presence of air during transfer of device to the sheath, Recall # Z-0257-2007

REASON: AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no confirmed complaints or adverse events related to this failure mode.

MANUFACTURER: Medrad Inc, Indianola, PA, by telephone and letter dated November 20, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Invasive Blood Pressure Interface Cables: a) Medrad 9500 Multigas monitor for MRI,
Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira IBP Transducer b) Invasive Blood Pressure Interface Cable (Part # 3008772) for use with Braun IBP Transducers. The product is an accessory to patient physiological monitor, Recall # Z-0258-2007; b) Veris Invasive Blood Pressure Interface Cables-Part # 3010478. The product is an accessory to patient physiological monitor, Recall # Z-0259-2007

REASON: Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.

MANUFACTURER: Recalling Firm: Guidant Corporation, Saint Paul, MN, by letter, dated October 9, 2006. Manufacturer: Guidant-Ireland, Clomel, County Tipperary, Ireland. Firm initiated recall is ongoing.

PRODUCT: Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), Recall # Z-0269-2007

REASON: Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed. 

MANUFACTURER: Recalling Firm: Arrow International Inc., Reading, PA, by letter on September 29, 2006. Manufacturer: Arrow International, Inc., Mount Holly, NJ. Firm initiated recall is ongoing.

PRODUCT: a) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber catheter. Latex Free A Port Ref Product No. AP-01007; Recall # Z-0270-2007; b) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Ref Product No. AP-01013 Latex-Free Low Profile Port, Recall # Z-0271-2007; c) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 17 Fr. Introducer Kit REF Product No. AP-06535, Recall # Z-0272-2007; d) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 10 Fr. Introducer Kit Ref Product No. AP-06530, Recall # Z-0273-2007; e) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port , 12 Fr. Introducer Kit. Ref Product Code: AP-06528, Recall # Z-0274-2007; f) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port, 10 Fr. Introducer Kit. Ref Product No. AP-06520, Recall # Z-0275-2007; g) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile B Port, 6 Fr. Introducer Kit. Ref Product No. AP-06046, Recall # Z-0276-2007;h) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit. Ref Product No. AP-06042, Recall # Z-0277-2007; i) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 9 Fr. Introducer Kit. Ref Product No. AP -06040, Recall # Z-0278-2007; j) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 6 Fr. Introducer Kit Ref. Product No. AP-06036, Recall # Z-0279-2007; k) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit Ref Product No. AP-06022, Recall # Z-0280-2007; l) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 9 Fr. Introducer Kit Ref Product No. AP-06020, Recall # Z-0281-2007; m) Implantable Vascular Access system --Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 9 Fr. Introducer Kit. Ref. Product No. AP-06018, Recall # Z-0282-2007; n) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 6 Fr. Introducer Kit. Ref. Product No. AP-06016, Recall # Z-0283-2007; o) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 10 Fr. Introducer Kit. Ref. Product No. AP-06015, Recall # Z-0284-2007;p) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 6 Fr. Introducer Kit. Ref Product No. AP-06014, Recall # Z-0285-2007;q) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 9 Fr. Introducer Kit Ref Product No. AP-06013, Recall # Z-0286-2007; r) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. Ref Product No. AP-01510, Recall # Z-0287-2007

REASON: Catheter has separated from the infusion port body.

MANUFACTURER: Mallinckrodt Inc., Cincinnati OH, by letter dated November 7, 2006. Firm initiated recall is ongoing.

PRODUCT: OptiVantage DH Power Injection System, Recall # Z-0288-2007

REASON: The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinician, contrast would be injected at a higher or lower flow rate than desired.

MANUFACTURER: Recalling Firm: Kavo America Corp, Lake Zurich IL, by letter, telephone and email on November 22, 2006. Manufacturer: Kaltenbach & Voigt Gmbh & Co. KG, Biberach, Germany. Firm initiated recall is ongoing.

PRODUCT: KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenance unit only; Made in Germany The spray was produced under the following labels: a) KaVo QUTTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, single can: item #04117630, type 2106, 6-pack: item #04117640, type 2106A b) KaVo QUTTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, single can: item #04117680, type 2107, 6-pack: item #04117690, type 2107A c) KaVo QUTTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, single can: item #04117590, type 2108, 6-pack: item #04117720, type 2108A, Recall # Z-0289-2007

REASON: The QUATROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury.

MANUFACTURER: Recalling Firm: Medtronic Neurological, Minneapolis, MN by letter dated July 2006. Manufacturer: Medtronic Puerto Rico Operations Co., MedRel, Juncos, PR. Firm initiated recall is ongoing.

PRODUCT: Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. The dual program model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via DBS extension or DBS leads. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case. The operation of the neurostimulator is supported by a clinician programmer, a therapy controller, and a control magnet, Recall # Z-0290-2007

REASON: A subset of Kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. Sudden cessation of therapy can result in the immediate return or worsening of underlying symptoms due to the progression of the disease state.

MANUFACTURER: Recalling Firm: Datex - Ohmeda, Inc., Madison WI, by letter in September 2006 Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.

PRODUCT: Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finland +358 10 39411, Recall # Z-0291-2007

REASON: Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient may be reduced. This could result in patient hypoventilation and hypoxia.

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by on site visit between January 2004 and September 2005. Firm initiated recall is ongoing.

PRODUCT: Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188, Recall # Z-0294-2007

REASON: The flow meter could malfunction resulting in loss of touchscreen control of the gas system, but the alternate mechanical control will remain operable.

MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond WA, by letter dated December 2006 another in January 2007. Firm initiated recall is ongoing.

PRODUCT: LIFEPAK 20 automatic external defibrillator, Recall # Z-0295-2007

REASON: LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power.

MANUFACTURER: St Jude Medical CRMD, Sylmar, CA, by letter on October 12, 2006, and by press release on October 13, 2006. Firm initiated recall is ongoing.

PRODUCT: a) St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510, Recall # Z-0296-2007; b) St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650, Recall # Z- 0297-2007; c) St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers), Recall # Z-0298-2007

REASON: St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status.

MANUFACTURER: Smiths Medical PM, Inc., Waukesha WI, by letter dated November 3, 2006. Firm initiated recall is ongoing.

PRODUCT: BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys (on/off, waveform/trend, alarm silence, menu/enter, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs, Recall # Z-0300-2007

REASON: An error occurred at the board manufacturing site which may affect the following parameters: - An electrical noise observed on the SpO2 pleth waveform generating and displaying erratic heart rates. % SpO2 reading displays dashes. The ECG waveform may appear noisy, ECG readings appear accurate. -Respiration waveform may appear noisy and the respiration readings will be displayed as dashes.

MANUFACTURER: Recalling Firm: Draeger Medical, Inc., Telford, PA, The recalling firm issued a recall letter to the US customers November 17, 2006. Manufacturer: Draeger Medical Systems Inc., Danvers, MA. Firm initiated recall is ongoing.

PRODUCT: a) Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375, Recall # Z-0301-2007; b) Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375, Recall # Z-0302-2007; c) Infinity Docking Station (IDS) (transportable patient monitor) Repair Kit, part number 7262814, Recall # Z-0303-2007

REASON: Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.

MANUFACTURER: Varian Medical Systems Inc., Palo Alto CA, by letter on September 21, 2006. Firm initiated recall is ongoing.

PRODUCT: 4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System; All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-Varian Treatment versions 6.6.5027 and below, Recall # Z-0304-2007

REASON: Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 20, 2006

CLASS I

MANUFACTURER: Discount Diabetic Supply, Oxford MS, by telephone on October 19, 2006 and by letter on October 30, 3006. Firm initiated recall is ongoing.

PRODUCT: One Touch Ultra test strips, LifeScan, a Johnson & Johnson Co., 50 test strips, 2 vials of 25 test strips, Recall # Z-0206-2007

REASON: Counterfeit-Blood glucose test strips were reported to be counterfeit.

MANUFACTURER: Medishop, Inc., Brooklyn, NY, by letters dated October 17, 2006. Firm initiated recall is ongoing.

PRODUCT: OneTouch®/Basic®/Profile® Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled in English, Greek and Portuguese), Recall # Z-0207-2007

REASON: Counterfeit-The product is reported to be counterfeit

CLASS II

MANUFACTURER: Recalling Firm: Advanced Medical Optics, Inc., Santa Ana CA, by letter and telephone on November 13, 2006. Manufacturer: A.M.O. Puerto Rico Manufacturing, Inc., Anasco, PR. Firm initiated recall is ongoing.

PRODUCT: AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses, Recall # Z-0148-2007

REASON: The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters.

MANUFACTURER: Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter dated September 14, 2006 and September 17, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280, Recall # Z-0233-2007; b) Terumo Perfusion System 9000, 220/240v, with color screen; Model 9000; Catalog No. 164290, Recall # Z-0234-2007; c) Terumo Perfusion System 9000, 115v, with color screen; Model 9000; Catalog No. 164300, Recall # Z-0235-2007; d) Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400, Recall # Z-0236-2007; e) Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401, Recall # Z-0237-2007;. f) Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405, Recall # Z-0238-2007; g) Terumo Perfusion System 8000 Base, 5 pump, 220240v; Model 8000; Catalog No. 16406, Recall # Z-0239-2007; h) Terumo Perfusion System 8000 Base, 4 pump, 100v, Model 8000; Catalog No. 16409, Recall Z-0240-2007; i) Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410., Recall # Z-0241-2007; j) Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268, Recall # Z-0242-2007

REASON: The hand crank handle may separate and detach from the unit during use.

MANUFACTURER: Smiths Medical ASD, Inc., Rockland, MA, by letter on or about November 6, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Level 1® Normothermic I.V. Fluid Administration Set REF D-60HL, Recall # Z-0250-2007;
b) Level 1® Normothermic I.V. Fluid Administration Set REF DI-60HL (Foreign Distribution Only), Recall # Z-0251-2007

REASON: IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on September 8, 2006. Manufacturer: Becton Dickinson Vacutainer Micrope, San Lorenzo, PR. Firm initiated recall is ongoing.

PRODUCT: BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200 (4X50) BD, Recall # Z-0253-2007

REASON: Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.

MANUFACTURER: Recalling Firm: Stryker Biotech, Hopkinton, MA, by letter on August 25, 2006. Manufacturer: Howmedica International S de RL, Limerick, Ireland. Firm initiated recall is ongoing.

PRODUCT: Calstrux™ (Previously known as TCP Putty)- Absorbable Bone Void Filler, packaged in: Catalog Number: 400-05: quantity-5cc Catalog Number: 400-10: quantity 10cc Catalog Number: 400-15: quantity 15cc, Recall # Z-0254-2007

REASON: Lack of Labeling Precautions. Calstrux™ should not be used in combination with other products and the volume used should approximate the size of the defect. Adverse reactions have been reported with over filling the defect site or combination product usage, including localized induration, swelling, inflammation, wound drainage, infection and device migration.

MANUFACTURER: Recalling Firm: Advanced Medical Optics, Inc., Santa Ana, CA, by letter on October 31, 2006. Manufacturer: A.M.O. Puerto Rico Manufacturing, Inc., Anasco PR. Firm initiated recall is ongoing.
PRODUCT: AMO PhacoFlex Il Model SI40NB Intraocular Lenses, Recall # Z-0267-2007

REASON: These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping.

MANUFACTURER: Medline Industries, Inc, Mundelein, IL, by telephone on November 21, 2006. Firm initiated recall is ongoing.

PRODUCT: Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO sterilized; Reorder DYND70660; 20 trays per case; Recall # Z-0268-2007

REASON: The product, labeled as sterile, had not gone through the sterilization process at the time of shipment

CLASS III

MANUFACTURER: Biogenex Laboratories, San Ramon, CA, by letter on approximately October 3, 2006. Firm initiated recall is ongoing.

PRODUCT: Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Recall # Z-0217-2007

REASON: Mislabeling: The product's "contents section " labeling (outer box) is mislabeled incorrectly printed as ''1 x 100 mL Alk Phos Label'' which should read ''1 x 100 mL HRP Label''. A second, smaller label, incorrectly reads "RTU MultiLink HPR/AEC" which should be labeled as "RTU MultiLink HPR". The reagent vials in the box are correctly labeled.

MANUFACTURER: Smiths Medical ASD, Inc., Gary, IN, by letter on November 17, 2006. Firm initiated recall is ongoing.

PRODUCT: Custom 5.5 mm Bivona® Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S, Recall # Z-0260-2007

REASON: Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 13, 2006

CLASS II

MANUFACTURER: Accumetrics, Inc., San Diego, CA, by letter or e-mail on September 5, 2006 – September 13, 2006. Firm initiated recall is ongoing.

PRODUCT: VerifyNow P2Y12 Assay Device Kit, Part Number 85054, Recall # Z-0228-2007

REASON: The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.

MANUFACTURER: BioMerieux, Inc., Durham, NC, by a field corrective action notification August 28, 2006. Firm initiated recall is ongoing.

PRODUCT: BioMerieux BacT/Alert SN Anaerobic Culture Bottle-REF 259790, Recall # Z-0243-2007

REASON: Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times.

MANUFACTURER: Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated October 31, 2006. Rusch Manufacturing (U.K.), Teleflex Medical, Armagh, N. Ireland. Firm initiated recall is ongoing.

PRODUCT: Neoprene Pecan Shaped Breathing Bag. Bag with 15 mm neck insert, size 1 liter, a rebreathing bag. Made in UK, Catalog Number (REF) 21176AP, Recall # Z-0244-2007

REASON: Mislabeling-The rebreathing bag is incorrectly labeled as a 1 liter. The rebreathing bag is actually a ½ liter bag.

MANUFACTURER: Abbott Laboratories, Santa Clara, CA. by letter on September 18, 2006. Firm initiated recall is ongoing.

PRODUCT: Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model Number: 99120-01, Recall # Z-0246-2007

REASON: Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.

MANUFACTURER: Dade Behring, Inc., West Sacramento, CA., by telephone and letters on September 27, 2006. Firm initiated recall is ongoing.

PRODUCT: Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D, Recall # Z-0247-2007

REASON: Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.

MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle, IL, by letters on October 30, 2006. Manufacturer: Medibo, N.V., Hanmont, Achel, Belgium. Firm initiated recall is ongoing.

PRODUCT: a) Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids; the kit is comprised of 2 x 200 cm ropes, 2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon nuts and 2 spacers; Arjo Inc., 50 N. Gary Avenue, Roselle, IL 60172; Model KS1006, Recall # Z-0248-2007;
b) Sling Rope/Connector Assembly Kits for the Sara Power standing and raising aids; the kit is comprised of 2 x 230 cm ropes, 2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon nuts and 2 spacers;
Model KS1019, Recall # Z-0249-2007

REASON: The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose.

CLASS III

MANUFACTURER: Ortho-Clinical Diagnostics, Rochester NY, by letters on October 9, 2006. Firm initiated recall is ongoing.

PRODUCT: VITROS® Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS® Chemistry Systems typically used in hospital laboratories. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08, Recall # Z-0245-2007

REASON: The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS® LIPA slides if they have been stored on the VITROS® Chemistry Systems for more than 2 days.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 6, 2006

CLASS II

MANUFACTURER: Lone Star Medical Products, Inc, StaffordTX., by letters on October 6, and November 8, 2004, and by telephone November 9 through November 12, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings,
Model #1104; Recall # Z-0212-2007; b) Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107, Recall # Z-0213-2007; c) Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1110, Recall # Z-0214-2007

REASON: Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received.

MANUFACTURER: Recalling Firm: Nihon Kohden America Inc, Foothill Ranch,CA, by telephone and fax starting September 1, 2006. Manufacturer: Nihon Kohden Corp., Shinjuku-ku, Tokyo, Japan. Firm initiated recall is ongoing.

PRODUCT: Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System), Recall # Z-0218-2007

REASON: When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time.

MANUFACTURER: Computerized Medical Systems, Inc., Saint Louis, MO, by letters dated November 9, 2006. Firm initiated recall is ongoing.

PRODUCT: AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system, Model #DS300, Recall # Z-0221-2007

REASON: The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.

MANUFACTURER: Inverness Medical Professional Diagnostics, Scarborough, ME, by letter on September 29, 2006. Firm initiated recall is ongoing.

PRODUCT: NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-00, Recall # Z-0222-2007.

REASON: Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S.pneumonia test pouches.

MANUFACTURER: Data Innovations, Inc., South Burlington,VT., by letter dated October 25, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Roche Modular Drive (rchmdlri), analytical laboratory data interface, Recall # Z-0223-2007;
b) Roche Cobas driver (rchcob6i), analytical laboratory data interface, Recall # Z-0224-2007

REASON Software of modular driver may incorrectly report patient results as Quality Control Results.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by Customer Safety Advisory on October 12, 2006. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.

PRODUCT: a) Magnetom Trio magnetic resonance imaging, Model number 7387074, Recall # Z-0225-2007;
b) Magnetom Trio TIM, magnetic resonance imaging, Model number 10018221, Model number 10018222, Recall # Z-0226-2007

REASON: Possible excessive RF exposure/may burn.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by press release and letters dated October 19, 2006. Firm initiated recall is ongoing.

PRODUCT: CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog Numbers 11937642190 [packaged 48 strips per box] and 11937634190 (packaged 12 strips per box), Recall # Z-0227-2007

REASON: Erroneous Test Results: Monitor may display "error" message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.

MANUFACTURER: Recalling Firm: Dentsply Friadent Ceramed, Lakewood, CO., by letter on November 17, 2006. Manufacturer: Dentsply Friadent GmbH, Mannheim, Germany. Firm initiated recall is ongoing.

PRODUCT: a) XiVE S plus Screw Implant D3.0/L11, Model Number 26-0122, Friadent GmbH. (dental implant), Recall # Z-0230-2007; b) XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant), Recall # Z-0231-2007; c) XiVE S plus Screw Implant D3.0/L15, Model Number 26-0125, Friadent GmbH. (dental implant), Recall # Z-0232-2007

REASON: Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.

CLASS III

MANUFACTURER: Recalling Firm: Laborie Medical Technologies, Williston,VT, by telephone on October 4-5, 2006. Manufacturer: Smiths Medical, DublinOH. Firm initiated recall is ongoing.

PRODUCT: Laborie Transducer Cartridge with Luer Lock Reference: DIS130, Recall # Z-0229-2007

REASON: Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 29, 2006

CLASS II

MANUFACTURER: Abbott Diagnostic International, Ltd., BarcelonetaPR, by letter on September 8, 2006. Firm initiated recall is ongoing.

PRODUCT: Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100, Recall # Z-0117-2007

REASON: Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on October 19, 2006. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.

PRODUCT: Modularis URO urological table, Model number 5531012, Recall # Z-0168-2007

REASON: Potential pinch point with the patient table

MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego,CA., by letter on July 30, 2003. Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is complete.

PRODUCT:
a) UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4, 26006 Femoral Component Size 6, 26008 Femoral Component Size 8 and 26010 Femoral Component Size 10, Recall # Z-0191-2007;
b) UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10, Recall # Z-0192-2007

REASON: There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component.

MANUFACTURER: Exactech, Inc., GainesvilleFL., by fax, e-mail and telephone on August 31, 2006. Firm initiated recall is ongoing.

PRODUCT: Optetrak, B-series cemented finned tibial tray, size 2f/2t. Catalog # 220-04-02, Recall # Z-0196-2007

REASON: Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.

MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea,CA., by letters the week of July 24, 2006. Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is ongoing.

PRODUCT: Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1, Recall # Z-0197-2007

REASON: Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a Mis-Identification condition.

MANUFACTURER: Iris Sample Processing, Westwood, MA, telephoned on September 29, 2006 . Firm initiated recall is ongoing.

PRODUCT: StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502, Recall # Z-0198-2007

REASON: Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker.

MANUFACTURER: Dako Colorado, Inc., Fort Collins, CO, by telephone on October 2, 2006 and by letter on October 20, 2006. Firm initiated recall is ongoing.

PRODUCT: Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, (Catalog No. (ER 00130, 00331, 00230, 00431), Recall # Z-0199-2007

REASON: Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used for patient diagnosis.

MANUFACTURER: Gambro Renal Products, Inc., LakewoodCO, by fax on May 12, 2006 and by letter on May 16, 2006. Manufacturer: Gambro Dasco S.p.A. Monitor Division, Medolla, Italy. Firm initiated recall is complete.

PRODUCT: Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Recall # Z-0200-2007

REASON: Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient.

MANUFACTURER: Datex - Ohmeda, Inc., Madison,WI, by letter dated September 15, 2006. Firm initiated recall is ongoing.

PRODUCT: Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane, Recall # Z-0201-2007

REASON: There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer.

MANUFACTURER: Access Point Medical LLC, St. Louis, MO, by telephone and letters dated March 9, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) Access Point Medical Canes, Cane, Off-Set Crook w/Strap-Black, Product Code CN10051, packaged 20/case, Recall # Z-0202-2007;
b) Access Point Medical Canes, Quad Cane, Medium Base (Gold, Chrome), Product Code CN11050, packaged 10/case., Z-0203-2007
c) Access Point Medical Canes, Quad Cane, Small Base - Gold, Product Code CN11050B, and Small Base - Chrome, Product Code CN11050C, both packaged 6/case, Recall # Z-0204-2007;
d) Access Point Medical Canes, Quad Cane, Large Base - Gold, Product Code CN11070B, and Large Base - Chrome, Product Code CN11070C, both packaged 6/case, Recall # Z-0205-2007

REASON: The canes were made of unacceptable materials and could break.

MANUFACTURER: Medtronic Vascular, Santa Rosa, CA, by letters on November 1, and November 3, 2006, and by telephone and email week of October 30, 2006. Firm initiated recall is ongoing.

PRODUCT: Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001, Recall # Z-0208-2007

REASON: Sterility may be compromised as evidenced by a loss of package integrity.

MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated October 12, 2006. Firm initiated recall is complete.

PRODUCT: Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemented use only, tivanium TI-6AL-4V alloy/UHMWPE, sterile; Catalog no. 05-5998-038-02, Recall # Z-0209-2007

REASON: The polyethylene tibial articular surface may not lock into some of the tibial plates.

MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated October 19, 2006. Firm initiated recall is ongoing.

PRODUCT: Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10, Recall # Z-0210-2007

REASON: The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal.

MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by service bulletin on September 1, 2006 and by telephone and email on October 13, 2006. Manufacturer: AGFC Corp., Mortsel, Belgium. Firm initiated recall is ongoing.

PRODUCT: CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405), Recall # Z-0219-2007

REASON: Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.

MANUFACTURER: Recalling Firm: Konica Minolta Medical Imaging USA, Inc., Wayne, NJ, by letters, fax, email and telephone on October 10, 2006.

Manufacturer: Konica Medical and Graphic Cor, Shinjuku-Ku, Tokyo, Japan. Firm initiated recall is ongoing.

PRODUCT: Konica Minolta PrintLink III Model - ID/IV, product code no. 0770, 0771 Medical Imaging Communication Device Model IV - product code 5000230 Model ID, product code 5000330, Recall # Z-0220-2007

REASON: The power supply of a unit located in Japan overheated and caused a smoke condition and a small amount of flame coming off the unit.

CLASS III

MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH, by letters on October 27, 2006. Firm initiated recall is ongoing

PRODUCT: Protex Continous Epidural anesthesia tray, Ref 4948-17, Recall # Z-0211-7

REASON: Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 22, 2006

CLASS II

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on October 612, 2006. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.

PRODUCT:
a) Allura X-per FD 10/10 x-ray, and fluoroscopy, Recall # Z-0165-2007;
b) Allura Xper FD 20/10 x-ray, and fluoroscopy, Recall # Z-0166-2007

REASON: Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.

MANUFACTURER: Data Innovations, Inc., South Burlington, VT, by an email listserv notification and by letter dated 8/17/06. Firm initiated recall is ongoing.

PRODUCT: Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R), Recall # Z-0167-2007

REASON: Patient results may be associated with an incorrect specimen.

MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Div, Mc Gaw Park, IL, by letters dated September 6, 2006. Manufacturer: Baxter Healthcare Corporation, Largo FL. Firm initiated recall is ongoing.

PRODUCT: Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R, Recall # Z-0169-2007

REASON: The Meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring.

MANUFACTURER: Bemis, Sheboygan Falls, WI, by letters on August 23, 2006, and September 13, 2006. Firm initiated recall is ongoing.

PRODUCT: 5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red, 040 Yellow, 24 count containers, Recall # Z-0170-2007

REASON: The 5 Quart Wall Safes are shipped as two pieces (bottom & top) that customers are unable to assemble because of excess warp in the back wall of the container.

MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis, TN, by letter on October 20, 2006. Manufacturer: Lenox-Maclaren Surgical Corp., Louisville, CO. Firm initiated recall is ongoing.

PRODUCT: Medtronic Sofamor Danek, Bone Fragmentor, Ref Number 9150111- Device, Recall # Z-0176-2007

REASON: Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.

MANUFACTURER: Linvatec Corp., Largo, FL, by letter on December 20, 2005. Firm initiated recall is ongoing.

PRODUCT: ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower Plus Handpieces) and sold individually, Recall # Z-0179-2007

REASON: The Sternum Saw Collet Nut that is used to insert and hold the saw blade in place may not always allow for the easy insertion of a saw blade into the handpiece for use. The nut needs to be in a certain position in order for the blade to be inserted and this may delay the operation of the device especially in emergency situations.

MANUFACTURER: Olsen Medical, Louisville, KY, by letter and e-mail August 29 - 30, 2006. Firm initiated recall is ongoing.

PRODUCT: MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and Model #30-0002. The electrodes are individually packaged in Tyvek bags with 12 packages per case, Recall # Z-0182-2007

REASON: Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user.

MANUFACTURER: Recalling Firm: Philips Medical Systems, Andover MA., by letter on September 21, 2006. Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Hewlett-Packard Strasse 2, Boblingen, Germany. Firm initiated recall is ongoing.

PRODUCT:
a) M3001A Philips Multi Measurement Server (MMS), Recall # Z-0183-2007;
b) M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with the IntelliVue or M3/M4 patient monitor M1002, Recall # Z-0184-2007

REASON: Unexpected pulse oximetry (Sp02) readings (100%) over time when a sensor is not attached to the patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM.

MANUFACTURER: Sorenson Medical, Inc., West Jordan, UT, by letter on October 10-11, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) ambIT Ambulatory Infusion Pump Cassette; Filterless, Spike, Sterile, Vol. 2.3ml, REF 220139, Recall # Z-0185-2007;
b) ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Recall # Z-0186-2007;
c) ambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile, Vol. 2.3ml, REF 220266, Recall # Z-0187-2007;
d) ambIT Ambulatory Infusion Pump Cassette; Filterless, Male, Sterile, Vol. 2.3ml, REF 220267, Recall # Z-0188-2007
REASON: Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.

MANUFACTURER: Recalling Firm: Eatonform Inc., Dayton OH, by letter on September 28, 2006. Manufacturer: Specialized Printed Forms, Caledonia NY. Firm initiated recall is ongoing.

PRODUCT: Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and distributed in cartons. Each carton contains 1,000 sets of four packets or 4,000 individual packets per carton, Recall # Z-0189-2007

REASON: The poly film may separate along the sealed seams of the packets of the Doc-U-Dose Prescription Management System causing the medications to unintentionally fall out of the packets prior to delivery to patient/consumers.

MANUFACTURER: Zimmer Spine, Inc., Minneapolis MN., by letters beginning October 12, 2006. Firm initiated recall is ongoing.

PRODUCT: Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. The Distal Thread Reduction Guide Pin is a reusable instrument that is part of a set of instruments used to perform reduction surgeries with the ST360 Spinal Fixation System. The ST360 Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, fixed and adjustable transverse connectors, Recall # Z-0190-2007.

REASON: Recall is due to an issue with the thread timing.

MANUFACTURER: Trionix Research Laboratory, Inc., Twinsburg, OH, by telephone on/about November 2, 2006. Firm initiated recall is ongoing.

PRODUCT: BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System, Recall # Z-0193-2007

REASON: The ball screw on the unit which supports the detector head (which weights approximately 800 lbs.) could snap resulting in the detector head dropping on the patient.

MANUFACTURER: Varian Medical Systems Inc., Palo Alto, CA, by letters on August 31, 2006. Firm initiated recall is ongoing.

PRODUCT: Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C, C/D EX) and 2300 C, C/D EX), Recall # Z-0194-2007:

REASON: The chain holding the device gantry in position may break.

MANUFACTURER: Ekos Corp., Bothell, WA, by letter, dated October 2, 2006. Firm initiated recall is ongoing.

PRODUCT: Lysus Transport Stand (infusion stand), part number 4896-003, Recall # Z-0195-2007

REASON: Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard.

CLASS III

MANUFACTURER: Recalling Firm: Asahi Medical Co., Ltd., Northbrook, IL, by letters on October 12, 2006. Manufacturer: Asahi Kasai Medical Co., Ltd., Oita Prefecture, Japan. Firm initiated recall is ongoing.

PRODUCT:
a) Asahi APS Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Made in Japan; 12 units per case; Models APS-18R and APS-900S - 1.8 m2 surface area, Model APS-21R and APS-1050S - 2.1 m2 surface area, Recall # Z-0171-2007;
b) Asahi Rexeed Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of polysulfone/PVP housed within a plastic casing of styrene copolymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Made in Japan; 12 units per case; Model Rexeed-15R - 1.5 m2 surface area, Model Rexeed-18R - 1.8 m2 surface area, Model Rexeed-21R - 2.1 m2 surface area, Model Rexeed-25R - 2.5 m2 surface area, Recall # Z-0172-2007;
c) Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Made in Japan; 12 unitsper case; Model AM-BIO-65 - 1.3 m2 surface area, Model AM-BIO-75 – 1.5 m2 surface area and Model AM-BIO-100 - 2.0 m2 surface area, Recall # Z-0173-2007;
d) Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Made in Japan; 12 units per case; Model AM-BIO-75D - 1.5 m2 surface area and Model AM-BIO-100D - 2.0 m2 surface area, Recall # Z-0174-2007;
e) Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Made in Japan; 12 units per case; Model AM-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface area and Model AM-NR-100U - 2.0 m2 surface area, Recall # Z-0175-2007
REASON: There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.

MANUFACTURER: Recalling Firm: Boston Scientific Target, Fremont, CA., by letters on October 6, 2006. Manufacturer: Boston Scientific Cork, LTD, Cork, Ireland. Firm initiated recall is ongoing.

PRODUCT: Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570, Recall # Z-0177-2007

REASON: Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct)

MANUFACTURER: Michigan Instruments, Inc., Grand Rapids, MI, by letter dated September 14, 2006. Firm initiated recall is ongoing.

PRODUCT: Michigan Instruments Thumper Mechanical CPR Device, Model 1007, Part number 15000, Recall # Z-0178-2007

REASON: Failure to initiate compressions when turned on.

MANUFACTURER: EBI, L.P., Parsippany NJ, by letter on September 6, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx only, Recall # Z-0180-2007;
b) VHS Pediatric Plate (for hip screw system) Ref 200501, VHS Pediatric Plate Stainless Steel Rx only, sterile, Recall # Z-0181-2007
REASON: VHS Plate and lag screw components did not assemble correctly intraoperatively.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 15, 2006

CLASS II

CORRECTION

Recall # Z-0078-2007, listed in November 8, 2006, Enforcement Report should be listed as a Class III Recall.

MANUFACTURER: Recalling Firm: Ciba Vision Corp., Duluth, GA, by letter on September 13, 2006. Manufacturer: Ciba Vision Puerto Rico, Inc., Cidra, PR. Firm initiated recall is ongoing.

PRODUCT: Z-0018-07
a) CSI® Daily Wear, soft (hydrophilic) contact lenses, Recall # Z-0018-2007;
b) CSI® Flexible Wear, soft (hydrophilic) contact lenses, Recall # Z-0019-2007;
c) CSI® Toric, soft (hydrophilic) contact lenses, Recall # Z-0020-2007

REASON: Out of specification lens curve.

MANUFACTURER: Datex -- Ohmeda, Inc., Madison, WI, by letters on August 10, 2006. Firm initiated recall is ongoing.

PRODUCT: GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, Recall # Z-0021-2007

REASON: Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface (valves) may occur that will invoke an alarm state. When this occurs 'Vaporizer Failure' will appear on the Aisys main display, with an accompanying audible alarm. Delivery of anesthetic Agent is halted; gas flow and ventilation are not affected.

MANUFACTURER: Enpath Medical, Inc., Minneapolis, MN, by telephone on July 7, and July 17, 2006 and by letters on July 10, and July 18, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar, Model 501204; 3.2 mm Low-Profile Bipolar Models 501206 and 501214. All labeled Sterile, Recall # Z-0120-2007;
b) Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an AngelMed Guardian IMD; Part No. 0208-2100-001, provided to Angel Medical Systems for International Clinical Studies; Sterile/ EO, Single Use. Model LA-001, Recall # Z-0121-2007

REASON: The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degrees of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.

MANUFACTURER: Hydrocision, Inc., Billerica, MA, by email on September 6, 2006. Firm initiated recall is complete.

PRODUCT:
a) HydroCision SpineJet XL MIS 20 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58662, Recall # Z-0123-2007;
b) Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58663, Recall # Z-0124-2007

REASON: Distal tip may become detached from the device.

MANUFACTURER: Recalling Firm: DePuy Spine, Inc., Raynham, MA, by letter on October 10, 2006. Firm initiated recall is ongoing

PRODUCT:
a) DePuy Spine Bremer 3-D Halo Crown System, Product Code: 2923-01-100, Recall # Z-0130-2007;
b) O Degree Slider Set, DePuy Spine Bremer Halo System, Product Code: 2923-01-010, Recall # Z-0131-2007;
c) 12 Degree Slider Set, DePuy Spine Bremer Halo System, Product Code: 2923-01-020, Recall # Z-0132-2007;
d) Small Halo Crown, DePuy Spine Bremer Halo System, Product Code: HT025, Recall # Z-0133-2007;
e) Large Halo Crown, DePuy Spine Bremer Halo System, Product Code: HT026, Recall # Z-0134-2007;
f) Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System, Product Code: HT025HI, Recall # Z-0135-2007;
g) Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System, Product Code: HT026HI, Recall # Z-0136-2007;
i) Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System, Product Code: HT001,
Recall # Z-0137-2007;
j) Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System, Product Code: HT002, Recall # Z-0138-2007;
k) Small Pediatric Ring, DePuy Spine Bremer Halo System, Product Code: PT001, Recall # Z-0139-2007;
l) Large Pediatric Ring, DePuy Spine Bremer Halo System, Product Code: PT002, Recall # Z-0140-2007;
m) Standard Skull Ring, DePuy Spine Bremer Halo System, Product Code: AC007, Recall # Z-0141-2007;
n) Skull pins w/torque, DePuy Spine Bremer Halo System, Product Code: AC014, Recall # Z-0142-2007;
o) Extra Long Skull pins, DePuy Spine Bremer Halo System, Product Code: AC018, Recall # Z-0143-2007;
p) HI Fix Skull pins, DePuy Spine Bremer Halo System, Product Code: AC020, Recall # Z-0144-2007

REASON: Sterility of device is compromised due to loss of package integrity.

MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated September 27, 2006 and September 28, 2006. Firm initiated recall is ongoing.

PRODUCT: VITROSâ Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROSâ Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma, Recall # Z-0151-2007

REASON: Positively biased results when using the VITROSâ Chemistry Products GLU DT Slides GEN 56.

MANUFACTURER: Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by visit on August 14, 2006. Firm initiated recall is complete.

PRODUCT: Hitachi Echelon Magnetic Resonance Imaging System, Recall # Z-0152-2007

REASON: Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.

MANUFACTURER: Precision Medical, Inc., Northampton, PA, by telephone on October 4, 2006. Firm initiated recall is ongoing.

PRODUCT: Precision Medical -- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number: 2201, Recall # Z-0153-2007

REASON: Component assembly; the fill chuck is not assembled properly which may allow the device to come apart over time releasing its contents.

MANUFACTURER: Recalling Firm: Access Point Medical LLC, St. Louis, MO, by telephone on or about June 20, 2006. Manufacturer: Danyang Changjiang Motorcycle, Danyang, China. Firm initiated recall is ongoing.

PRODUCT:
a) Access Point Medical-Heavy Duty Rollator (rolling walker), Product Code: RL12010HD, with seat, backrest, 8" wheels with locks, maximum capacity 400 lbs., and wire basket, Recall # Z-0154-2007;
b) Access Point Medical-Heavy Duty Rollator with Curved Back (rolling walker), Product Code: RL12011, with seat, curved backrest, 8" wheels with locks, maximum capacity 400 lbs., and wire basket, Recall # Z-0155-2007

REASON: The fork component on the wheel of the Rollator can break due to the use of

MANUFACTURER: Recalling Firm: Lumiport, LLC, Provo, UT, by email or telephone beginning September 28, 2006. Manufacturer: Ningbo Haishu Qualik Optoelectronics Corp., Ningbo, China. Firm initiated recall is ongoing.

PRODUCT: DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin blemishes; portable home therapy, Recall # Z-0156-2007

REASON: Incorrect charger, batteries may overheat, catch fire or explode while being charged with the charger enclosed with the device.

MANUFACTURER: Recalling Firm: Maquet, Inc., Bridgewater, NJ, by letter on September 13, 2006. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.

PRODUCT: Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank, Article # 923391, Recall # Z-0158-2007

REASON: The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill.

MANUFACTURER: Recalling Firm: Maquet Inc, Bridgewater NJ, by letter on October 3, 2006. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.

PRODUCT: Jostra HL-20 Heart Lung Machine - guiding pins, Recall # Z-0159-2007

REASON: The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in the tube guide rolls, they cannot roll smoothly and finally they can get stuck.

MANUFACTURER: Cook Endoscopy, Winston Salem, NC, by letter on October 13, 2006. Firm initiated recall is ongoing.

PRODUCT: Fusion OMNI ERCP Catheter, Recall # Z-0160-2007

REASON: Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.

MANUFACTURER: USA Instruments Inc., Aurora OH, by letters dated September 20, 2006 and October 13, 2006. Firm initiated recall is ongoing.

PRODUCT:

a) 1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System, Recall # Z-0163-2007;
b) 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System, Recall # Z-0164-2007

REASON: The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized RF burn and/or electrical shock to a patient on which the device is being used.

CLASS III

PRODUCT: Michigan Instruments Thumper Mechanical CPR Device, Model 1007, Recall # Z-0119-2007

MANUFACTURER: Michigan Instruments, Inc., Grand Rapids, MI, by letter dated August 4, 2006. Firm initiated recall is ongoing.

REASON: Failure to initiate compressions when first turned on, if improperly shut down -- Operator Manual updated to include proper shut down procedures.

MANUFACTURER: Recalling Firm: Teleflex Medical, Bannockburn IL, letters dated September 27, 2006. Manufacturer: Hudson RCI Tecate S.de R.L. de C.V., Teleflex Medical, Tecate, B.C., Mexico. Firm initiated recall is ongoing.

PRODUCT:
a) Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff, 19 mm bronchial cuff; a Rx, sterile, single use endobronchial tube with modified tip for left bronchial intubation; catalog number (REF) 5-16037, Recall # Z-0125-2007;
b) Sheridan Preformed Uncuffed Oral Tracheal Tube, 3.0 mm; a Rx, sterile, single use tracheal tube; catalog number (REF) 5-22006, Recall # Z-0126-2007;
c) Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use tracheal tube; catalog number (REF) 5-22210, Recall # Z-0127-2007;
d) Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a Rx, sterile, single use tracheal tube; catalog number (REF) 5-22315, Recall # Z-0128-2007;
e) Sheridan T.T.X. Tracheal Tube Exchanger, Large Size for tracheal tube sizes 7.5 mm -- 10.0 mm; a Rx, sterile, single use tracheal tube exchanger; catalog number (REF) 5-24006, Recall # Z-0129-2007

REASON: Biological indicator failed. Investigation eliminated all equipment and product related factors.

MANUFACTURER: Recalling Firm: Plus Orthopedics, USA, San Diego, CA, by telephone on June 27, 2006. Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.

PRODUCT: Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226, Recall # Z-0149-2007

REASON: Possibility of pressure plate fractures/breakage.

MANUFACTURER: Home Access Health Corp., Hoffman Estates, IL, by letters dated October 6, 2006. Firm initiated recall is ongoing.

PRODUCT: Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an unique PIN, the instructions for use and ''Frequently Asked Questions'', a polybag component that includes two lancets, one gauze pad, one adhesive bandage and one alcohol prep pad, a specimen return envelope and a prepaid return mailer either designated as U.S. first class or FedEx; UPC 0 83170 51000 5, Recall # Z-0150-2007

REASON: Wrong Expiration Date; the kits were labeled with Expiration/Use By dates; that exceed the expiration dates of the sterile safety lancet component of the kit.

MANUFACTURER: St. Jude Medical/Diag. Division, Minnetonka, MN, by letters on June 7, 2006. Firm initiated recall is complete.

PRODUCT: Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size, Recall # Z-0157-2007

REASON: The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038" guidewire vs. the required 0.035" guidewire.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 8, 2006

CLASS II

Class II Device Recall Extended.

Z-1502-06 was reported in the September 20, 2006 Enforcement Report. The recall has been extended to include 310 more devices.

MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on August 30, 2006. On 10/19/06 the firm mailed an identical letter dated October 2006 to customers for units that were later identified as being subject to the recall. Firm initiated recall is ongoing.

PRODUCT: LIFEPAK 20 external defibrillator/monitor, Recall # Z-1502-06

REASON: Devices with v38 system software do not display a "LOW BATTERY: CONNECT TO AC POWER" message when the monitor is on backup (DC) battery power and may shut down without warning.

MANUFACTURER: Hardy Media Inc., Dba Hardy Diag, Santa Maria, CA, by telephone, fax and letter on August 21, 2006 and by letter September 25, 2006. Firm initiated recall is ongoing.

PRODUCT: HardyCHROM 0157, Catalogue Number: G305, Packaged: 10 plates per sleeve, Recall # Z-0078-2007

REASON: This recall is being conducted due to performance failure; the product is failing to show pigment development for E. coli 0157.

MANUFACTURER: Conmed Corporation, Utica, NY, by letter dated October 1, 2006. Firm initiated recall is ongoing.

PRODUCT: ConMed DetachaTip® Laparoscopic Instrument: Allis Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1019. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0083-2007;
ConMed DetachaTip® Laparoscopic Instrument: Allis Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4319. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility Recall # Z-0084-2007;
ConMed DetachaTip® Laparoscopic Instrument: Babcock Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1005. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0085-2007;
ConMed DetachaTip® Laparoscopic Instrument: Babcock Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4305. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0086-2007;
ConMed DetachaTip® Laparoscopic Instrument: Curved ''Maryland'' Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1009. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0087-2007;
ConMed DetachaTip® Laparoscopic Instrument: Curved ''Maryland'' Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4308. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0088-2007;
ConMed DetachaTip® Laparoscopic Instrument: Endoweave Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4328. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0089-2007;
ConMed DetachaTip® Laparoscopic Instrument: Fenestrated (Duckbill) Multiple Use Grasper, 5mm x 43cm, REF/Product Code 1-4307. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0090-2007;
ConMed DetachaTip® Laparoscopic Instrument: Meeker (Right Angle) Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1017. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0091-2007;
ConMed DetachaTip® Laparoscopic Instrument: Meeker (Right Angle) Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4317. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0092-2007;
ConMed Laparoscopic Instrument: Allis Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-006. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0093-2007;
ConMed Laparoscopic Instrument: Allis Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-436. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0094-2007;
ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6047-001. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0095-2007;
ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6047-431. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0096-2007;
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-002. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0097-2007;
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-432. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0098-2007;
ConMed Laparoscopic Instrument: Endoweave Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-005. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0099-2007;
ConMed Laparoscopic Instrument: Endoweave Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-435. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0100-2007;
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-003. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0101-2007;
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-433. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0102-2007;
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-004. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0103-2007;
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-434. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0104-2007;
ConMed Laparoscopic Instrument: Allis Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-006. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0105-2007;
ConMed Laparoscopic Instrument: Allis Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-436. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0106-2007;
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-002. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0107-2007;
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-432. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0108-2007;
ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-005. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0109-2007;
ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-435. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0110-2007;
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-003. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0111-2007;
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-433. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0112-2007;
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-004. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0113-2007;
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-434. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0114-2007;

REASON: The grasper jaws broke during Laparoscopic procedures at the junction of the jaw and the tube.

MANUFACTURER: Venoscope LLC, Lafayette, LA, by telephone beginning on April 28, 2006. Firm initiated recall is complete.

PRODUCT: Venoscope Neonatal Transilluminator, Model NT01, Recall # Z-0116-2007

REASON: Excessive heating due to incorrect wire assembly process.

MANUFACTURER: Enpath Medical, Inc., Plymouth MN, by letter on June 29, 2006 and by telephone on June 27, and July 6, 2006. Firm initiated recall is ongoing.

PRODUCT: Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Recall # Z-0118-2007

REASON: Enpath has become aware that some of the Enpath Medical 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber.

MANUFACTURER: First Aid Only Inc, Vancouver, WA, by letter dated August 17, 2006. Firm initiated recall is ongoing.

PRODUCT: First Aid kits, First Aid Only brand, containing various products to include acetaminophen and other first aid supplies, various sizes, - travel size, all purpose, first aid response kit, on-the-road, recreational, outdoor, Recall # Z-0145-2007; First Aid kits, Pharmacist's Choice, containing acetaminophen and a variety of first aid items, all purpose first aid kit, Recall # Z-0146-2007; First Aid Kit, Nexcare brand, all purpose first aid kit containing acetaminophen and a variety of first aid supplies. Recall # Z-0147-2007

REASON: Kits contain acetaminophen tablets that were recalled due to being contaminated with mold.

CLASS III

MANUFACTURER: Recalling Firm: Ortho-Clinical Diagnostics, Rochester NY, by letters dated March 6, 2006. Manufacturer: Data Innovations, Inc., South Burlington, VT. Firm initiated recall is ongoing.

PRODUCT: VITROS® WorkCentre, Catalog # 6802159, using enGen™ Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.'s branded version of Instrument Manager™, Recall # Z-0077-2007

REASON: Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre).

MANUFACTURER: Recalling Firm: Tosoh Bioscience Inc, Grove City OH, by letters on September 5, 2006. Manufacturer: Tosoh Corporation, Minato-Ku 43123, Japan. Firm initiated recall is ongoing.

PRODUCT: Tosoh AIA-Pack Folate Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1 ml glass vials with 12 glass vials per box, Recall # Z-0082-2007

REASON: Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument.

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by recall notification packages on August 10, 2005 Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland. Firm initiated recall is complete.

PRODUCT: Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990, Recall # Z-0122-2007

REASON: Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 1, 2006

CLASS II

MANUFACTURER: Recalling Firm: Kendall a Division of Tyco Healthcare Group LP, Argyle, NY, by letter on September 12, 2006. Manufacturer: Kendall, Deland, FL. Firm initiated recall is ongoing.

PRODUCT: Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc-27x1-1/4 A) Product # 888153744, Recall # Z-0051-2007

REASON: Incorrect needle. There is an incorrect needle configuration on the syringe. The correct needle has a 27 gage A-bevel, the needle on the syringe has no bevel, typically used for dental irrigation.

MANUFACTURER: Recalling Firm: GE Healthcare, Wauwatosa, WI, by letter on June 23, 2006. Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.

PRODUCT: ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with antenna, the network infrastructure, A computer platform running the ApexPro Telemetry Application and a computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)., Recall # Z-0054-2007

REASON: System Warning Alarm failure: When a patient being monitored is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC does not occur.

MANUFACTURER: Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by telephone on September 14, 2006. Manufacturer: Depuy-Cork Div. Of Depuy Orthopaedics, Ringaskiddy County Cork, Ireland. Firm initiated recall is complete.

PRODUCT: Depuy PFC Oval Dome Patella, Part Number 960100, 3-Peg. 32 mm, sterile, REF 96-0100, Recall # Z-0057-2007

REASON: Mislabeled units containing a size 32 mm. Patella were labeled as a 38 mm patella.

MANUFACTURER: Recalling Firm: Cardinal Health, McGaw Park, IL, by letters dated September 27, 2006. Manufacturer: Cirpro De Delicias, Parque Industrial Las Virgenes, Panamericana, Apartado Postal, Mexico. Firm initiated recall is ongoing.

PRODUCT: a) Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Made in Mexico. The cardiovascular drapes were packaged under the following configurations: a) Catalog #9158 - 1 CV split drape
b) Catalog #9158CE - 8 x 1 CV split drape, Recall # Z-0058-2007;
b) Convertors Cardiovascular Split Pack II, the pack contains 1 Tiburon Cardiovascular Split Drape II and 3 Astound Surgical Gowns; Sterile, for single use only; Made in Mexico; Catalog #29158, Recall # Z-0059-2007;
c) Presource Custom Sterile Packs containing the Cardiovascular Split Drape II; the custom sterile packs were packaged with the bulk, non-sterile drapes and then the complete custom pack was sterilized; identified by the following catalog numbers: a) SVC13AMEMK - Sterile Open Heart Adult Pack;
b) SCV31OHMPJ -- Sterile Open Heart w Drapes Pack;
c) SVC42OPVCG - Sterile Open Heart Adult Pack;
d) SCV32CPMUO - Sterile CAB 146060 Pack;
e) SCV34OHTMJ - Sterile Basin Pack;
f) SCV31LVLUM - Sterile Liver Transplant Pack;
g) SCV19CVHHF -- Sterile Cardiovascular Pack;
h) SCV11ADLLD - Sterile Open Heart/Adult;
i) SCV92CBHRB - Sterile CABG Pack;
j) SCV92CASIA - Sterile Cardiovascular Pack;
k) SBA32GSMUL - Sterile General Surgery Pack;
l) SCV30OHKWA - Sterile Open Heart Pack;
m) SBA31LVLUM - Sterile Liver Transplant Pack;
n) SBA35LTBLQ - Sterile Lung Transplant Pack;
o) SCV44CVDEB - Sterile CV Pack;
p) SCV22OHMES - Open Heart Pack;
q) SCV23AOSFH - Open Heart Part 3;
r) SCV43OHHRF - Open Heart;
s) SCV24CAGME - CABG Drape Pack;
t) SAN12CCKGB - Cardiac Pack;
u) SBA13BRBSE - Breast Reduction;
v) SCV11CBNYP - CABG G 3;
w) SCV11CESLB - C.V. Drape Pack;
x) SCV11CGCPR - CABG;
y) SCV11CGXXB - CABG Pack;
z) SCV11CJICL - Cardiac Major;
aa) SCV11CTMUK - C T Set Up;
bb) SCV11DPMYG - S Drape Pack;
cc) SCV11HEMMI - Open Heart A B;
dd) SCV11MRCPE - Major Cardiac;
ee) SCV11OCNYN - OH CABG;
ff) SCV11OHLD2 - Open Heart A&B Pack;
gg) SCV11OHNMC - Open Heart;
hh) SCV11OPLKC - O P CABG;
ii) SCV11VASLB - C V Valve Drape;
jj) SCV11VLNYM - G 3 Valve;
kk) SCV12OHYHY - Graft and Linen;
ll) SCV13AABSV - Aortic Aneurysm;
mm) SCV13AMEMJ - Open Heart Pack B;
nn) SCV13BBEMC - Cardio-Thoracic Aux;
oo) SCV13CB767 - CABG;
pp) SCV13OHCAI - Open Heart Pack;
qq) SCV13OOBIG - Open Heart Drape;
rr) SCV14O1BGO - Open Heart Pack A;
ss) SCV22OHPGA - Open Heart Pack;
tt) SCV22OOMSE - Open Heart Preferred;
uu) SCV24OH20A - Open Heart Drape Pack;
vv) SCV43DREJI - Open Heart Drape Pack;
ww) SCV69OH17E - Open Heart;
xx) SCV59HVSGJ - Heart Valve Pack;
yy) SCV59OHNVM - Open Heart Pack;
zz) SCV53HTDMG - Open Heart;
aaa) SCV56CH11A - Open Heart Pack;
bbb) SCV59MJTCW - Open Heart Pack;
ccc) SCV52OH97F - Open Heart Pack;
ddd) SCV41OHHIE - Open Heart Pack;
eee) SCV52HTSJE - Open Heart Pack;
fff) SCV59OHMHV - Basic Heart Pack; Recall # Z-0060-2007;
d) Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box; Made in Mexico; catalog #9158N, Recall # Z-0061-2007;
e) Cardinal Health Sterile Presource PBDS Modules, have Presource Custom Sterile Packs containing the Cardiovascular Split Drape II or a Sterile Convertors Tiburon Cardiovascular Split Drape II bundled in the module; identified by the following catalog numbers: PBDS modules containing catalog 9158: PC40OHRJR - Basic Open Heart Kit, RWJ; PC40OHRJT - Basic Open Heart Kit, RWJ; PBDS modules containing custom sterile packs:
a) PWOCBSBSE - Breast Reduction Kit, pack SBA13BRBSE;
b) PC40CGSLK - CABG Kit, pack SCV11CESLB;
c) PCOCCGNYO - CABG Kit, pack SCV11OCNYN;
d) PCOCOHNME - Open Heart Kit, pack SCV11OHNMC;
e) PC40VPSLD - Valve Kit, pack SCV11VASLB;
f) PC78OHUVZ - Open Heart Kit, pack SCV56CH11A;
g) PC82OH16C - Open Heart Kit, pack SCV59MJTCW;
h) PC82OH17O - Open Heart Kit, pack SCV69OH17E;
i) PCVROHDMI - Open Heart Kit, pack SCV53HTDMG;
j) PC15CGFCL - CABG Kit, pack SCV32CPMUO;
k) PCOCOHLLD - Open Heart Kit - Adult, pack SCV11ADLLD;
l) PG15OTFCI - General Surgery Kit, pack SBA32GSMUL;
m) PGCGLRLUP - Liver Transplant Kit 747340, pack SBA31LVLUM;
n) PC13OHEMR - Open Heart Adult Pack Kit, pack SCV13AMEMJ;
o) PC60CJICX - Cardiac Major Kit, pack SCV11CJICL;
p) PCOCOHMMK - Open Heart AB Kit, pack SCV11HEMMI;
q) PCV2CG34A - G 3 CABG Kit, pack SCV11CBNYP;
r) PCV2CP10J - CABG Kit, pack SCV11CGCPR;
s) PCV2VRNHW - G 3 Valve Kit, pack SCV11VLNYM;
t) PVOCAA76F - AAA Kit, pack SCV13AABSV
u) UCV42OPVC3 - Open Heart Kit, pack SCV42OPVCG;
v) PC92CBHRB - CABG 2 of 2 Kit, pack SCV92CBHRB;
w) PC44CGDEB - CV Kit, pack SCV44CVDEB;
x) PC22OHMHW - Open Heart Kit, pack SCV22OHMES;
y) PC23OPSFH - Open Heart Kit, pack SCV23AOSFH;
z) PC43OHHRG - Open Heart Kit, pack SCV43OHHRF;
aa) PV24CAGME - CABG Kit, pack SCV24CAGME,

Recall # Z-0062-2007

REASON: The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.

MANUFACTURER: Smiths Medical MD, Inc., Saint Paul, MN, by telephone, facsimile and letter on September 27, 2006. Firm initiated recall is ongoing.

PRODUCT:
a) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4672-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, Vein Pick, Point-Lok Sharps Safety Device, Product Information. EtO Sterilized. Single Use, Recall # Z-0064-2007;
b) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4673-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, 20G GRIPPER PLUS non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr introducer, 2 'J' Guidewires, 2 Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use, Recall # Z-0065-2007;
c) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4683-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheterwith CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, 20G GRIPPER PLUS non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr introducer, 2 'J' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use, Recall # Z-0066-2007;d) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT Elite Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4690-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, Vein Pick, Point-Lok Sharps Safety Device, Product Information. EtO Sterilized. Single Use, Recall # Z-0067-2007

REASON: Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are supplied on the outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an insufficient seal and product sterility could be compromised.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter, dated September 20, 2006. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.

PRODUCT: Sienet Cosmos V15C, model number 10018969, Recall # Z-0069-2007

REASON: Potential loss of images. Images may not be successfully sent to the RAID system.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter, dated September 5, 2006. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.

PRODUCT:
a) Syngo Imaging, picture archiving and communications system. Model number 7502029, Recall # Z-0070-2007;
b) Sienet Sky, picture archiving and communications system.
Model number 8463163, Recall # Z-0071-2007;
c) Sienet Magic View 300, picture archiving and communications system. Model numbers 10014063 and 10014064, Recall # Z-0072-2007

REASON: Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.

MANUFACTURER: Cook, Inc., Bloomington, IN, by telephone on September 21, 2006. Firm initiated recall is ongoing.

PRODUCT: Cook Zilver 635 Billary Stent -- Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-4.0-40, Recall # Z-0080-2007

REASON: The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40).

MANUFACTURER: Boston Scientific Corp., Spencer, IN, by letter dated September 21, 2006. Firm initiated recall is ongoing.

PRODUCT: Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set, REF/catalog no. 27-135. Universal Product Number (UPN) M001271350, Recall # Z-0081-2007

REASON: Sterility compromised/package integrity: the bottom of the Tyvek pouch may not have been sealed.

MANUFACTURER: Recalling Firm: Radiometer America, Inc., Westlake, OH, by telephone on July 6, 2006 and by letter dated July 21, 2006. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.

PRODUCT: Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer, Catalog Numbers: 914-418 and 914-426, Recall # Z-0115-2007

REASON: Incorrect FI02 (Fraction of Inspired Oxygen) values: programming issue can cause incorrect values to be transmitted to the LIS when: 1)- The FI02 result is edited in the manual sample processing mode- 2)- An existing result is opened and FI02 is then edited and sent….In both cases RADIANCE will transmit the original FI02 value, not the value that was edited.

CLASS III

MANUFACTURER: Guidant Corporation, Saint Paul, MN, by visits on June 5, 2006. Firm initiated recall is ongoing.

PRODUCT: Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators, Recall # Z-0002-2007

REASON: Final software load did not occur prior to shipment of select programmers.

MANUFACTURER: Invacare Corporation, Sanford, FL, by e-mail on September 27, 2006. Firm initiated recall is ongoing.

PRODUCT: AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected Model numbers: IH820-3MDLX, IHSC900DLX, IH820-3MDLX-QS, IH820-3MPDLX-QS, SC900-80WDLX-QSP, SC900-80PDLX-QSP, IH820-3MDLX-AE-333PS, SC90080GDLX-AE-366PA, SC90080GDLX-AE-333PS, IH820-3MDLX-AE-366PS, IH820-3MDLX-AE-333PA, IH820-3MDLX-AE-366PA and SC90080GDLX-AE-366PS, Recall # Z-0063-2007

REASON: The incorrect caution label that describes washing instructions was applied to beds distributed in the US, i.e. the specified label is P/N 1116654 (English translation); the label that was used is P/N 1119165 (French translation).

MANUFACTURER: Organogenesis, Inc., Canton, MA, by fax and telephone on October 2, 2006. Firm initiated recall is ongoing.

PRODUCT: Apligraf (Graftskin), Recall # Z-0068-2007

REASON: Product pH out of specification.

MANUFACTURER: Recalling Firm: Sebia, Inc., Norcross, GA, by fax letter and telephone on or about August 29, 2006. Manufacturer: Sebia, Evry, France. Firm initiated recall is ongoing.

PRODUCT: HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Cat. Number 4126, Recall # Z-0073-2007

REASON: The material used in packaging leaches into the product resulting in the presence of an additional artifact band above the HbA fraction.

MANUFACTURER: Recalling Firm: ATS Medical, Inc., Minneapolis, MN, by fax on April 7, 2006 and by letter on May 5, 2006. Manufacturer: CryoCath Technologies, Inc., Kirkland, Canada. Firm initiated recall is complete.

PRODUCT: CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console, Recall # Z-0079-2007

REASON: Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiration date while the correct date is one (1) year.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 25, 2006:

CLASS I

MANUFACTURER: Recalling Firm: Medtronic Neurological, Minneapolis, MN, by letter beginning June 6, 2006. Manufacturer: Medtronic, Inc. Cardiac Rhythm Management, Minneapolis, MN. Firm initiated recall is ongoing.

PRODUCT: Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories, Recall # Z-0022-2007

REASON: The Catheter Access Port (CAP) on SynchroMed EL pumps manufactured between March and July 1999 may detach from the main body of the pump, which can interrupt drug flow to the target site.

CLASS II

MANUFACTURER: Recalling Firm: Extended Care Air Therapy Systems Inc, Roseville OH, by letter on April 5, 2006 and by follow-up letters in May and June Manufacturer: GF Health Products, Inc., Fond Du Lac WI. Firm initiated recall is complete.

PRODUCT: ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed, Recall # Z-0026-2007

REASON: Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall.

MANUFACTURER: Becton Dickinson & Company, Franklin Lakes, NJ, by letter on August 24, 2006. Manufacturer: BD Preanalytical Solutions, Sumter, SC. Firm initiated recall is ongoing.

PRODUCT: BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile REF 368656 23G x 3/4'' x 12'' 0.6 x 19mm x 305mm ----- REF 367352 21G x 3/4'' x 12'' 0.8 x 19mm x 305mm, Catalog number 367352, Catalog number 367352, Catalog number 367352, Catalog number 368656, Catalog number 368656, Catalog number 368656, Catalog number 368656, Catalog number 368656, Recall # Z-0034-2007

REASON: A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have pre-activated or have defects affecting package integrity.

MANUFACTURER: Recalling Firm: Medline Industries, Inc., Mundelein, IL, by letters dated July 20, 2006. Manufacturer: Changzhou Kwang Yang Motor Co., Ltd, Changzhou, Jangsu, China. Firm initiated recall is ongoing.

PRODUCT: a) Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; model MDS807600 - red and MDS807600B -- blue, Recall # Z-0036-2007; b) Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; model MDS807650 - red and MDS807650B -- blue, Recall # Z-0037-2007

REASON: Under conditions of heavy use, signs of overheating of the main battery cables have been observed.

MANUFACTURER: Eagle Parts and Products, Augusta, GA, by letters on July 11, and 28, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors, Recall # Z-0039-2007; b) Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors, Recall # Z-0040-2007 CO/DE Serial numbers 624EZ0010 through 624EZ0513

REASON: The wheel hub bolts may loosen resulting in the wheels coming off.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter beginning September 30, 2006. Firm initiated recall is ongoing.

PRODUCT: GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation, Catalog Numbers 887208 and 887210, Recall # Z-0041-2007

REASON: Missing, mixed or lost patient images may result after X-ray procedures. Navigational error.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter beginning September 29, 2006. Firm initiated recall is ongoing.

PRODUCT: GE OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, Recall # Z-0042-2007

REASON: X-ray system may lose or mix images and/or lose patient data.

MANUFACTURER: Recalling Firm: Bioplate Inc, Los Angeles CA, by telephone on September 14, 2006 and by letter on September 16, 2006 Manufacturer: Midwest Plastic Components, Minneapolis, MN. Firm initiated recall is ongoing.

PRODUCT: Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45, Recall # Z-0043-2007

REASON: Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.

MANUFACTURER: Excelsior Medical Corp., Neptune, NJ, by letter on April 24, 2006 and April 28, 2006. Firm initiated recall is complete.

PRODUCT: 0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100 under Hospira's label, Syrex, Recall # Z-0044-2007

REASON: The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.

MANUFACTURER: Recalling Firm: Eatonform, Inc., Dayton, OH, by letters on August 2, 2006, August 4, 2006, and August 11, 2006. Manufacturer: Ward/Kraft, Inc., Fort Scott, KN. Firm initiated recall is ongoing.

PRODUCT: Doc-U-Dose Prescription Management System, Item #8-PKIT, a daily activity assist device under 21 C.F.R. 890.5050. The product is distributed in cartons. There are 1,000 sets of four (4) packets, or 4,000 individual packets per carton. Each set is one day's worth of four packets, which are labeled, ''morning,'' ''noon,'' ''evening,'' and ''bedtime,'' Recall # Z-0045-2007

REASON: Certain lots of packet components of the firm's Doc-U-Dose Prescription Management System are separating from the paper along the sealed seam at the bottom of the packets causing the medications inside the separated compartments to fall completely out of the packet, or to become mixed into the wrong compartment of the packaging.

MANUFACTURER: Respironics California, Inc., Carlsbad, CA, by letter on August 8, 2006. Firm initiated recall is ongoing.

PRODUCT: Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN 1018246, Recall # Z-0047-2007

REASON: This action is being initiated due to power supply snubber board failures on certain Esprit Ventilators in countries that utilize operating voltages of 200-240 Volts AC and will involve the replacement of the Esprit Ventilator power supply snubber board. Returned power supplies have shown evidence of overheating and in some cases, in which a fan also failed, have shown signs of fire damage.

MANUFACTURER: Recalling Firm: Draeger Medical, Inc., Telford, PA, by letters on October 3, 2006. Manufacturer: Drager Medical AG & Co. KGAA, Luebeck, Germany. Firm initiated recall is ongoing.

PRODUCT: Favius GS Anesthesia Machine. Catalog number 8604699, Recall # Z-0048-2007.

REASON: One of four casters may break loose from chassis.

MANUFACTURER: Del Medical Systems Group, Franklin Park, IL, by letters dated October 3, 2006. Firm initiated recall is ongoing.

PRODUCT: DynaRad Phantom Portable X-Ray System; Phantom model (PH-150-CM & PH-150-G), Recall # Z-0049-2007

REASON: The x-ray tube head assembly of the Phantom Portable X-Ray System may detach from the boom arm assembly. The tube head could fall and contact the patient or operator.

MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, by letter dated August 1, 2006 and August 2, 2006. Manufacturer: Centex Machining, Inc., Round Rock, TX. Firm initiated recall is ongoing.

PRODUCT: Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic), Recall # Z-0050-2007

REASON: Bone reamer may not have a cutting surface on the tip.

MANUFACTURER: AGA Medical Corporation, Golden Valley MN, by via fax and letter, dated June 1, 2006. Firm initiated recall is ongoing.

PRODUCT: AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile EO. MRI Compatible. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh, Recall # Z-0052-2007; b) AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. MRI Compatible. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh, Recall # Z-0053-2007

REASON: AMPLATZER PFO Occluders were mislabeled with incorrect device size. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. This device was not distributed within the United States and does not affect U.S. consignees.

MANUFACTURER: Recalling Firm: General Electric Healthcare, Wauwatosa, WI, by letter dated August 4, 2006. Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.

PRODUCT: GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data acquisition transmitters; -The receiver antenna system infrastructure; -The receivers; -The receiver subsystem; -A computer platform running the Apex Pro Telemetry Application; -A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application), Recall # Z-0055-2007

REASON: When a patient being monitored with ApexPro/Apex Pro CH Telemetry with ST monitoring disabled is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC (Clinical Information Center) does not occur.

CLASS III

MANUFACTURER: Sunrise Medical, Somerset, PA, by telephone on August 24, 2006 and by letter on August 28, 2006. Firm initiated recall is ongoing.

PRODUCT: DeVilbiss iFill Personal Oxygen Station model number 535D, Recall # Z-0038-2007

REASON: Potential for oxygen cylinders to not fill completely.

MANUFACTURER: Smiths Medical ASD, Inc., Gary IN, by letter on August 11, 2006. Firm initiated recall is ongoing.

PRODUCT: Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, REF 60A 160, Recall # Z-0046-2007

REASON: The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.

MANUFACTURER: Recalling Firm: EM Innovations, Inc. Galloway, OH, by telephone on April 3-5, 2006 and July 11, 2006. Manufacturer: Enterprise Plastics, Kent, OH. Firm initiated recall is ongoing.

PRODUCT: Stic Kit Needle Containment Device, Model EMI 82691, packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band, Recall # Z-0056-2007

REASON: The firm failed to include User Instructions with the Stic Kit Needle Containment Device, when shipped.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 18, 2006:

CLASS II

MANUFACTURER: Thoratec Corp., Pleasanton, CA, by letters on January 26, 2004. Firm initiated recall is ongoing.

PRODUCT: Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Numbers: Catalogue numbers: 100118--Short, 14mm graft: #100121--Long, 14mm graft; #100129--Long, 18mm graft, Recall # Z-0015-2007

REASON: During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.

MANUFACTURER: Sunrise Medical CCG, Inc., Stevens Point, WI, by telephone beginning January 2006. Firm initiated recall is ongoing.

PRODUCT: Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL, U770 GNDAL, Recall # Z-0016-2007

REASON: The control box used in the actuator systems appears to have a potential to become stuck in one position resulting a non-functioning bed.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated August 10, 2006. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200, Recall # Z-0017-2007

REASON: The patient pendant cord represents a potential trip hazard for the patient or the caregiver.

MANUFACTURER: Abbott Diagnostic International, Ltd., Barceloneta,PR, by letter, on September 7, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use, Recall # Z-0023-2007; b) FSH Calibrators (LN 9C06-01), for in vitro diagnostic use, Recall # Z-0024-2007; c) Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use, Recall # Z-0025-2007

REASON: Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.

MANUFACTURER: 3M Company / Medical Division, South St PaulMN, by letters on August 14, 2006. Firm initiated recall is ongoing.

PRODUCT: 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant, Recall # Z-0027-2007

REASON: 3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing.

MANUFACTURER: Lumenis Inc., Santa Clara, CA, by letters and telephone on August 26, 2006. The firm initiated recall is ongoing.

PRODUCT: Lumenis brand DuoTome SideLite(tm) 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01, Recall # Z-0028-2007

REASON: Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use.

MANUFACTURER: Hitachi Medical Systems America Inc, Twinsburg, OH, by letter on August 16, 2006. Firm initiated recall is ongoing.

PRODUCT: MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J, Recall # Z-0029-2007

REASON: Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate.

MANUFACTURER: Recalling Firm: Arrow International Inc, ReadingPA, by letter on June 20. 2006. Manufacturer: Arrow International, Inc., Mount Holly,NJ. Firm initiated recall is ongoing.

PRODUCT: Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart, Recall # Z-0030-2007

REASON: The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed.

MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by letter on June 28, 2006.

Manufacturer: AGFA Corp., Mortsel, Belgium. Firm initiated recall is ongoing.

PRODUCT: CR DX-S, Image Intensified Fluoroscopic X-ray system, Recall # Z-0031-2007

REASON: Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.

MANUFACTURER: Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO, by letter on May 16, 2006. Manufacturer: Gambro Dasco S.p.A, Monitor Division, Medolla, Italy. Firm initiated recall is ongoing.

PRODUCT: Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Recall # Z-0032-2007

REASON: A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.

MANUFACTURER: AGFA Corp., Greenville, SC, by letter on August 8, 2006. Firm initiated recall is ongoing.

PRODUCT: IMPAX® 5.2 Systems with CAD Capability (Computer Assisted Diagnosis), Recall # Z-0033-2007

REASON: Failed CAD displayed as 'No Findings'.

MANUFACTURER: Haemonetics Corp., Eastern Maine Medical Center, Braintree, MA, by letters on July 28, 2006. Firm initiated recall is complete.

PRODUCT: SmartSuction Harmony Powered Suction Device, Model number: HAR-E-115-US, Recall # Z-0035-2007

REASON: Faulty circuit board may short circuit and cause electric shock to operator.

CLASS III

MANUFACTURER: Recalling Firm: Integrated Orbital Implants Inc, San Diego,CA, by email on February 27, 2006. Manufacturer: Interpore Cross International Inc, IrvineCA. Firm initiated recall is complete.

PRODUCT: Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S, Recall # Z-0012-2007

REASON: The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 11, 2006:

CLASS II

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on April 28, 2006. Firm initiated recall is ongoing.

PRODUCT: MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system, Recall # Z-0704-06

REASON: Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on August 14-15, 2006. Firm initiated recall is ongoing.

PRODUCT: a) GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, Recall # Z-1301-06; b) GE OEC 9800 Fluoro C-Arm X-ray system, Recall # Z-1302-06; c) RUS Tool Version Software, Recall # Z-1303-06

REASON: X-ray systems could provide output which exceeds the 20 R/minute limit.

MANUFACTURER: General Electric Med Systems, LLC, Waukesha, WI, by GE Field service representative visit beginning on September 22, 2006. Firm initiated recall is ongoing.

PRODUCT: GE Precision RX/I System, Recall # 1485-06

REASON: Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv).

MANUFACTURER: Smith & Nephew, Inc., Endoscopy Division, Andover, MA, by letter and telephone on May 22, 2006. Firm initiated recall is ongoing.

PRODUCT: Smith & Nephew Hip Positioning System Ref: 72200624 with System Components. Perineal Post 72200631 Universal Hip Distractor 72200626 Knee Holder 72200627 Well Leg Holder 72200632 Supine Table Extension 72200629, Recall # Z-1514-06

REASON: The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure.

MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letters dated June 9, 2006 and June 21, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood. Catalog number A7504-CTL, Recall # Z-1543-06; b) Alcohol Reagent Set for the quantitative determination of ethyl alcohol in serum. Imported and marketed in India. Catalog number A7504-150-S, Recall # Z-1544-06; c) Alcohol Standard, 100 mg/di, Catalog # A7504-STD, Recall # Z-1545-06; d) Alcohol Control, Catalog # 7-A7504-CTL, Recall # Z-1546-06; e) Alcohol Control, Level 1. Catalog # 7-A7504-CTL-L1, Recall # Z-1547-06; f) Alcohol Control, Level 2. Catalog # 7-A7504-CTL-L2, Recall # Z-1548-06; g) Alcohol Standard, Catalog # 7-A7504-STD, Recall # Z-1549-06

REASON: Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on May 31, 2006. Firm initiated recall is ongoing.

PRODUCT: GE 4 inch Anterior Cervical Post, GE Part Number: 1006385 or 1006385-NAV, (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems), Recall # Z-0001-07

REASON: Weld defect -- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.

MANUFACTURER: Thoratec Corp., Pleasanton, CA, by letters on August 26, 2006. Firm initiated recall is ongoing.

PRODUCT: Thoratec brand TLC-11 Portable Ventricular Assist Device (VAD) Driver, Recall # Z-0004-07

REASON: Sticky valve disk -- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.

MANUFACTURER: Stryker Instruments, Division of Stryker Corporation, Portage, MI, by letter dated September 8, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Stryker Navigation System, eNite System with Dell laptop computer model D800, Stryker # 7700-300-000, Recall # Z-0005-07; b) Stryker Navigation System Remote Planning Station with Dell laptop computer model D800, Stryker # 7700-010-000, Recall # Z-0006-07; c) Stryker Navigation System, Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064, Recall # Z-0007-07; d) Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800, Stryker # 6000-200-000, Recall # Z-0008-07

REASON: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.

MANUFACTURER: Recalling Firm: Smith & Nephew, Inc., Memphis, TN, by letter and telephone on August 29, 2006. Manufacturer: Southeastern Technology, Inc., Murfreesboro, TN. Firm initiated recall is ongoing.

PRODUCT: a) Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817, Recall # Z-0009-07; b) Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486, Recall # Z-0010-07; c) Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105, Recall # Z-0011-07

REASON: Tibial punches were not manufactured to specification and could break at the tip during use.

CLASS III

MANUFACTURER: Axis-Shield Diagnostics, Ltd., Dundee, Scotland, UK, by letter beginning November 11-16, 2005. Firm initiated recall is ongoing.

PRODUCT: Axis-Shield DIASTAT Anti-CCP test kit, code FCCP200, Recall # Z-0003-07

REASON: The preservative sodium azide used in the Kit Negative Control (part number FCOM175 was at the wrong concentration -- the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 4, 2006:

CLASS II

MANUFACTURER: Terumo Cardiovascular Systems Corp., Tustin, CA, by letters on June 23, 2006. Firm initiated recall is ongoing.

PRODUCT: Terumo Khuri Myocardial PH Monitoring System, Catalog number 7205, Recall # Z-1517-06

REASON: Lack of Assurance of Sterility: These specific lots of sensors lack supporting documentation for sterilization assurance.

MANUFACTURER: Kerr Corp., Orange CA, by letter on August 14, 2006 and by fax on August 16, 2006. Firm initiated recall is ongoing.

PRODUCT: RempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637, Recall # Z-1524-06

REASON: Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured).

MANUFACTURER: Recalling Firm: Becton Dickinson and Co., Franklin Lakes, NJ, by letters on July 28, 2006. Manufacturer: BD Medical -- Diabetes Care, Holdrege, NB. Firm initiated recall is ongoing.

PRODUCT: BD 1mL Safety Glide Allergy and Tuberculin Syringes. Reorder Number 305945 and 305950, Recall # Z-1525-06

REASON: BD received reports of needle assembly disengagement from the syringe.

MANUFACTURER: Ogenix Corporation, Cleveland, OH, by telephone on March 24, 2006. Firm initiated recall is complete.

PRODUCT: Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery, Recall # Z-1526-06

REASON: Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG from distribution.

MANUFACTURER: Recalling Firm: International Medsurg Connection, Inc., Schaumburg, IL, by telephone on August 16, 2006 and follow-up letter dated August 24, 2006.Manufacturer: Texstrip Manufacturing, Sdn Bhd, Selangor Daru Pehsan, Malaysia. Firm initiated recall is ongoing.

PRODUCT: a) Allegiance Esmark 4” x 108” Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Catalog 24593-043A, Recall # Z-1527-06; b) Allegiance Esmark 4” x 144” Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Catalog 24593-044A, Recall # Z-1528-06; c) Allegiance Esmark 6” x 108” Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Catalog 24593-063A, Recall # Z-1529-06; d) Allegiance Esmark 6” x 144” Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Catalog 24593-064A, Recall # Z-1530-06;

REASON: The bandages labeled as sterile had not been sterilized prior to distribution.

MANUFACTURER: Recalling Firm: Codman & Shurtleff, Inc., Raynham, MA, by telephone and fax on August 4, 2006. Manufacturer: Codman Sarl, Lelocle, Switzerland. Firm initiated recall is ongoing.

PRODUCT: a) Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Number: 82-1730, Recall # Z-1533-06; b) Codman External Drainage System 3 CSF (EDS 3) Without Ventricular Catheter Catalog Number: 82-1731, Recall # Z-1534-06

REASON: Sterility of device is compromised due to package seal defects.

MANUFACTURER: Recalling Firm: Respironics Novametrix, LLC, Wallingford CT, by letter on August 28, 2006. Manufacturer: Respironics California, Inc., Carlsbad, CA. Firm initiated recall is ongoing.

PRODUCT: NICO Model 7300 Cardiopulmonary Management System, Recall # Z-1535-06

REASON: Audible alarm may not sound during an alert condition

MANUFACTURER: Recalling Firm: Micrus Endovascular Corporation, San Jose, CA, by letters on September 8, 2006. Manufacturer: Lake Region Manufacturing, Inc., Chaska, MN. Firm initiated recall is ongoing.
PRODUCT: Micrus brand WATUSI Guidewire 0.014” -- Soft Tip, Catalog Number: WST 140205-00, Recall # Z-1542-06
REASON: During use, the introducer may cause the guide wire's coating to strip off and may result in loose material which could break free and enter the blood stream.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., IndianapolisIN, by letter dated September 15, 2006. Manufacturer: Roche Diagnostics GmbH, PenzbergIndiana, Germany. Firm initiated recall is ongoing.

PRODUCT: Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122), Recall # Z-1550-06

REASON: Gel-like particle formation; may result in a clot settling in the analyzer measuring cell, which will create a low signal and may cause incorrectly high or low QC and/or patient results depending on the assay method.

CLASS III

MANUFACTURER: Recalling Firm: Medline Industries Inc., Mundelein, IL, by letters dated July 20, 2006. Manufacturer: Kwang Yang Motor Co., Ltd., Kaohsiung, Taiwan, Republic of China. Firm initiated recall is ongoing.

PRODUCT: a) Medline Strider Midi 3 Scooter; a three wheeled battery operated scooter; model MDS807500 -- red and MDS807500B -- blue, Recall # Z-1522-06; b) Medline Strider Midi 4 Scooter; a four wheeled battery operated scooter; model MDS807550 - red and MDS807550B -- blue, Recall # Z-1523-06

REASON: The P&G Solo 60A electronic control unit on the Midi Scooters may overheat.

MANUFACTURER: Conva Tec, Skillman, NJ, by letter on July 31, 2006. Firm initiated recall is ongoing.

PRODUCT: a) ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 15) 1 ¾” 45mm; REF 175772; UPC 00031 75772, Recall # Z-1531-06; b) ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 60) 1 ¾” 45mm; REF 413145; UPC 0034 131445, Recall # Z-1532-06

REASON: Cartons may contain one or more units that are 1 ½” size rather than 1 ¾” size as indicated on the label.

MANUFACTURER: Medtronic Neurological, Minneapolis, MN, by a product Hold Order issued August 2, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Recall # Z-1536-06; b) Medtronic 3778 Lead Kit, 1x8 Compact Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Recall # Z-1537-06

REASON: Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage.

MANUFACTURER: Recalling Firm: Boston Scientific, Maple Grove, MN, by letter, dated August 31, 2006. Manufacturer: Boston Scientific Corporation, Miami, FL. Firm initiated recall is ongoing.

PRODUCT: a) Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped 'J' tip. Made in USA, Recall # Z-1538-06; b) Boston Scientific PT2 Light Support Guide Wire 300cm J-Tip, Catalog Number 38931-02 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped 'J' tip. Made in USA, Recall # Z-1539-06; c) Boston Scientific PT2 Moderate Support Guide Wire 185cm J-Tip, Catalog Number 38931-03 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped 'J' tip. Made in USA, Recall # Z-1540-06; d) Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped 'J' tip. Made in USA, Recall # Z-1541-06

REASON: The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 27, 2006

CLASS II

MANUFACTURER: General Electric Med Systems LLC, WaukeshaWI, by letter, dated November 24, 2005 was hand delivered to all customers beginning May 15, 2006. Firm initiated recall is ongoing.

PRODUCT: GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an X-ray generator; angulating table with x-ray Tube, collimator and image intensifier; wall stand; Overhead tube suspension; operator console and digital archive system, Recall # Z-1304-06

REASON: Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective barrier is not in position to intercept the entire cross section of the useful beam

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, letter dated August 18, 2006. Firm initiated recall is ongoing.

PRODUCT: Hil-Rom Affinity Three Birthing Bed, Model P3700, Recall # Z-1503-06

REASON: The cable on the auxiliary outlet may become pinched, which may result in an electrical short with melting of the plastic transformer and the emission of smoke.

MANUFACTURER: Recalling Firm: Therakos, Inc., Exton, PA, by letter dated July 18, 2006. Manufacturer: Harmac Medical Products, Inc., Buffalo, NY. Firm initiated recall is ongoing.

PRODUCT: Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument, Catalog number XT125, Recall # Z-1504-06

REASON: Centrifuge Bowl may leak.

MANUFACTURER: Recalling Firm: Becton Dickinson & Co, SparksMD, by e-mail, faxed letters, and certified courier on August 17, 2006 Manufacturer: Oxoid, Ltd, Basingstoke, UK. Firm initiated recall is ongoing.

PRODUCT: BD™ BBL™ Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents and labware, Recall # Z-1505-06

REASON: False Negative Staphylococcus aureus results which could prevent infected patients from receiving antimicrobial treatment; due to the failure of the Positive Control to react within 20 seconds. The failure is due to reduced reactivity of the latex component.

MANUFACTURER: Conmed Electrosurgery, Centennial,CO, by letter on September 1, 2006 and September 7, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Recall # Z-1507-06; b) Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, Recall Z-1508-06

REASON: Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.

MANUFACTURER: Invacare Corp., Elyria, OH, by telephone on June 23, 2006 and by letter dated June 26, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Solara 2G manual wheelchair, Recall # Z-1509-06; b) Solara Spree GT manual wheelchair, Recall # Z-1510-06; c) Solara Spree XT (SPRXT) manual wheelchair, Recall # Z-1511-06

REASON: The wheelchairs with the Travel Ready Option (TRRO) may contain incorrectly finished oval tie down brackets. The inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.

MANUFACTURER: Recalling Firm: Boston Scientific, Maple Grove,MN, by letters dated July 21, 2006. Manufacturer: Boston Scientific Corporation, etterkenny, Ireland. Firm initiated recall is ongoing.

PRODUCT: Boston Scientific Cutting Balloon Ultra2 Monorail Device, Recall # Z-1512-06

REASON: Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)

MANUFACTURER: Styker Medical Division of Styker Corp., Portage, MI, by letter dated August 29, 2006. Firm initiated recall is ongoing.

PRODUCT: Stryker Power-Pro Powered Ambulance Cot, Model 6500, Recall # Z-1513-06

REASON: The head section wheel assembly may flex outward from the cot because the head section wheel bolts, which hold the assembly upright, may back out.

MANUFACTURER: Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY, by e-mail on August 4, 2006. Firm initiated recall is ongoing.

PRODUCT: ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part/Catalogue Number 086-A001, Recall # Z-1516-06

REASON: Sample/Patient mis-identification (software defect) the system can associate a test result and sample identification (SID) with an incorrect patient name when the Patient Demographics feature is used and the Patient Identification (PID) field is left blank.

MANUFACTURER: Recalling Firm: Beckman Coulter Inc, BreaCA, by letter was sent on July 28, 2006. Manufacturer: Beckman Coulter Inc, Florence, KY. Firm initiated recall is ongoing.

PRODUCT: UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer, Recall # Z-1518-06

REASON: The neck of the wash buffer cube can be extended higher than intended possibly causing the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty. This may lead to incorrect assay results.

MANUFACTURER: Kerr Corp, Orange, CA, by letter on August 29, 2006. Firm initiated recall is ongoing.

PRODUCT: OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966, Recall # Z-1521-06

REASON: Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength.

CLASS III

MANUFACTURER: Recalling Firm: J. Jamner Surgical Instruments, Inc., Hawthorne, NY, by letter dated April 24, 2006. Manufacturer: Rebstock, Durbheim, Germany. Firm initiated recall is ongoing.

PRODUCT: Ruggles(tm) Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383. The Leyla Ball Joint Clamp is part of the Table Mounting Hardware that is used with the Leyla Retractor System. The Leyla Table Mounting Hardware consists of the Ball Joint Clamp, the Rigid Holding Rod, the Coupling Head, and the Coupling Head Turn Table. The Ball Joint Clamp is available individually or as part of the Table Mount Set. The Table Mounting Hardware are attachments to operating room surgical tables. The product is supplied non-sterile and may be packaged individually or as part of the Table Mount Set, Recall # Z-1506-06

REASON: The Ruggles(tm) Leyla Ball Joint Clamp may not properly tighten onto the Rigid Holding Rod. Although this condition can be observed during assembly, if the device were to be used during surgery, any attachments to the Rigid Holding Rod could move.

MANUFACTURER: Recalling Firm: Porex Surgical, Inc., Newnan, GA, by telephone, on July 11, 2006 and follow-up letter on July 12, 2006. Manufacturer: G. E. Silicones, Lic, Waterford, NY. Firm initiated recall is ongoing.

PRODUCT: Porex Nostril Retainers, Catalog #7241, Size 4, Recall # Z-1515-06

REASON: Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material.

MANUFACTURER: Biogenex Laboratories, San RamonCA, by letter on September 5, 2006. Firm initiated recall is ongoing.

PRODUCT: Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M, Recall # Z-1519-06

REASON: Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.

MANUFACTURER: Oasis Medical, Inc., Glendora, CA, by fax and certified mail on July 5, 2006. Firm initiated recall is ongoing.

PRODUCT: OASIS® Medical SOFT PLUG® Extended Duration Plug, Reference 6403, Recall # Z-1520-06

REASON: Labeled with an incorrect diameter.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 20, 2006

CLASS I

MANUFACTURER: Recalling Firm: Disetronic Medical System, Fishers, IN, by press release and letter dated July 13, 2006. Manufacturer: Disetronic Medical Systems AG, Burgdorf, Switzerland. Firm initiated recall is ongoing.

PRODUCT: Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001, Recall # Z-1413-06

REASON: The battery may turn the pump off without warning due to a design change in the battery.

MANUFACTURER: Medtronic Neurological, Minneapolis,MN, by letter on July 20, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems using Medtronic implantable pumps) The catheter is designed for use in the intrathecal space, Recall # Z-1414-06;b) Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement parts for the distal section of the 8731 Intrathecal Catheter), Recall # Z-1415-06

REASON: Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.

MANUFACTURER: Cardinal Health 303 Inc DBA Alaris Products, San Diego, CA, by letters dated August 15, 2006. Firm initiated recall is ongoing.

PRODUCT: Alaris® SE Pump (formerly Signature Edition® Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232, Recall # Z-1484-06.

REASON: This recall was initiated because of a potential for over infusion with all models of the Alaris® SE Pumps (formerly the Signature Edition® Infusion Pumps) caused by key bounce.

CLASS II

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes,NJ, by letters on June 21, 2006. Manufacturer: BD Preanalytical Solutions, Sumter,SC. Firm initiated recall is ongoing.

PRODUCT: a) BD Vacutainer Blood Collection Assembly with BD Blunt Plastic Cannula; Catalog #303380, Recall # Z-1461-06;b) BD Vacutainer Luer Adapter; Catalog #367290 and #367300, Recall # Z-1462-06;.c) BD Direct Draw Adapters, Catalog Number 364896, Recall # Z-1463-06

REASON: Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.

MANUFACTURER: Recalling Firm: Philips Medical Systems, AndoverMA, by letter dated July 21, 2006. Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Federal Republic of Germany. Firm initiated recall is ongoing.

PRODUCT: IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A, Recall # Z-1487-06

REASON: Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached

MANUFACTURER: Recalling Firm: Cobe Cardiovascular, Inc, Arvada, CO, by telephone and e-mail on August 4, 2006. Manufacturer: Sorin Group Italia Srl, Mirandola Modena, Italy. Firm initiated recall is ongoing.

PRODUCT: a) dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, Recall # Z-1488-06;b) dideco Preassembled Surgical Wash Set, Electa Essential , Cobe part numbers WS55E, WS125E, WS175E, WS225E, Recall # Z-1489-06; c) Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C, Recall # Z-1490-06;d) Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17, Recall # Z-1491-06

REASON: Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.

MANUFACTURER: Recalling Firm: Cordis Corporation, Miami Lakes, FL, by letter on July 21, 2006. Manufacturer: Lake Region Mfg Co, Inc, ChaskaMN. Firm initiated recall is ongoing.

PRODUCT: a) CORDIS SV-5 Steerable Guidewire, 180 cm., 5 Steerable Guidewires, ENDOVASCULAR, Catalog # 503558, Recall # Z-1492-06; b) CORDIS-SV-5 Steerable Guidewire, 300 cm.,5 Steerable Guidewires, Cordis a Johnson Johnson Company ,ENDOVASCULAR, Catalog # 503558X, Recall # Z-1493-06; c) CORDIS SV-8 Steerable Guidewire, 180 cm, 5 Steerable Guidewires, ENDOVASCULAR, Catalog # 503658, Recall # Z-1494-06; d) CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires, ENDOVASCULAR, Catalog # 503658X, Recall # Z-1495-06

REASON: Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.

MANUFACTURER: Recalling Firm: Skytron, Div. The KMW Group, Inc, Grand Rapids, MI, by a service bulletin on August 12, 2005. Manufacturer: Mizuho Medical Co, Ltd., Tokyo, Japan. Firm initiated recall is ongoing.

PRODUCT: a) Skytron General Purpose Surgical Table; Model 6600, Recall # Z-1496-06; b) Skytron General Purpose Surgical Table, battery model; Model 6600B, Recall # Z-1497-06

REASON: The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop.

MANUFACTURER: Greiner Bio-One North America, Inc., Monroe, NC, by fax on August 2, 2006. Firm initiated recall is ongoing.

PRODUCT: Greiner bio-one, Vacuette® Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile *, Recall # Z-1498-06

REASON: Coagulation tubes found with no additive.

MANUFACTURER: Boston Scientific Corp, Spencer,IN, by letter on August 10, 2006. Firm initiated recall is ongoing.

PRODUCT: Boston Scientific vanSonnenberg Sump with 'J' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201, Recall # Z-1499-06

REASON: Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.

MANUFACTURER: Xiros Plc, Leeds, United Kingdom, by telephone and letters on June 1, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001, Recall # Z-1500-06; b) Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010, Recall # Z-1501-06

REASON: The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles.

MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on August 30, 2006. Firm initiated recall is ongoing.

PRODUCT: LIFEPAK 20 external defibrillator/monitor, Recall # Z-1502-06

REASON: Devices with v38 system software do not display a "LOW BATTERY: CONNECT TO AC POWER" message when the monitor is on backup (DC) battery power and may shut down without warning.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 13, 2006

CLASS I

MANUFACTURER: Recalling Firm: Bausch & Lomb, Rochester, NY, by press release on April 13, 2006 and by letters on April 14, 2006. Manufacturer: Bausch & Lomb, Greenville, SC. Firm initiated recall is ongoing.

PRODUCT: Bausch & Lomb * ReNu® with MoistureLoc®, Multi-purpose soft contact lens solution * Sterile, Recall # Z-1201-06

REASON: Reports of Fusarium Infections among contact lens wearers

CLASS II

MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by letter in November 2005. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall ongoing.

PRODUCT: D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor). Model #D826, Part Number: 904-308, Recall # Z-1436-06

REASON: Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations

MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on June 26, 2006. Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

PRODUCT: FP1000 Cell Preparation System Part Number 624922, Recall # Z-1466-06

REASON: During the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Cell Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results.

MANUFACTURER: Zimmer Inc., Warsaw, IN, by letter dated August 2, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium Tl-6AL-4V alloy, sterile, w/calcicoat ceramic coating; Cat. no. 65-7861-14-04 (65786101404), Recall # Z-1467-06;b) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium TI-6AL-4Valloy, sterile; Cat. no. 7861-14-04 (00786101404), Recall # Z-1468-06;c) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 15, 140 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-15-04 (00786101504), Recall # Z-1469-06;d) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 17, 150 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-17-04 (00786101704), Recall # Z-1470-06;e) Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit,collarless, 12/14 neck taper - standard body -extended neck offset, size 14, 149 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum, sterile; Cat. no. 00-7864-014-20 (00786401420), Recall # Z-1471-06;f) Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -extended neck offset, size 15, 160 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum, sterile; Cat. no. 00-7864-015-20 (00786401520), Recall # Z-1472-06;g) Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -standard neck offset, size 16, 171 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum, sterile; Ref. no. 00-7864-016-00 (Cat. no. 00786401600), Recall # Z-1473-06;h) Zimmer MAYO Conservative hip prosthesis femoral stem, porous, 12/14 neck taper, large+, tivanium TI-6AL-4V alloy, sterile; REF. 8026-13-05 (Cat. no. 00802601305), Recall # Z-1474-06;i) Zimmer MAYO Conservative hip prosthesis femoral stem, porous, 12/14 neck taper, extra large, tivanium TI-6AL-4V alloy, sterile, REF. 8026-14 (Cat. no. 00802601400), Recall # Z-1475-06;j) Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, spout body, size D, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9990-20-46 (Cat. no. 00999002046), Recall # Z-1476-06;k) Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, cone body, size C, 55 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9993-19-55 (Cat. no. 00999301955), Recall # Z-1477-06;l) Zimmer ZMR Hip System 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; REF. 9996-19-35 (Cat. no. 00999601935), Recall # Z-1478-06;m) Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C, 45 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-45 (Cat. no. 00999601945), Recall # Z-1479-06; n) Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size F, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-23-35 (Cat. no. 00999602335), Recall # Z-1480-06 REASON: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.

MANUFACTURER: Cordis Neurovascular, Inc., Miami Lakes, FL, by letter on August 14, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters, Recall # Z-1482-06; b) Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters, Recall # Z-1483-06

REASON: Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch.

MANUFACTURER: Recalling Firm: Invacare Corporation, ElyriaOH, by letter on or about July 20, 2006. Manufacturer: Kuschall Ag, Witteswil, Switzerland. Firm Initiated recall is ongoing.

PRODUCT: Kuschall's K3/K4 Series of Manual Wheelchair, Model Airlite, Recall # Z-1486-06

REASON: If the user has chosen to install optional anti-tippers on the chair, the anti-tipper as designed may not be able to bear the stress of repeated or quick loads placed on it, causing the bolt to bend or break.

CLASS III

MANUFACTURER: Hardy Media Inc Dba Hardy Diag, Santa MariaCA, by telephone on June 28, 2006. Firm initiated recall is ongoing.

PRODUCT: BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Recall # Z-1451-6

REASON: This recall is being conducted due to the performance failure nearing the end of the product shelf life.

MANUFACTURER: CryoCath Technologies Inc., Kirkland, Canada, by letter on August 4, 2006. Firm initiated recall is ongoing.

PRODUCT: 7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc. Recall # Z-1452-06

REASON: Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1

MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by a Field Action memo on April 7, 2006. Manufacturer: Radiometer Medical ApS, Akandevej 21,Bronshoj, Denmark. Firm initiated recall is ongoing.

PRODUCT: TCM4 Series Monitoring System (Base Unit) Model: 391-876 (affected device), transcutaneous oxygen monitor; Compact Flash cards - Model #: 914-698 (Defective Device Component), Recall # Z-1453-06

REASON: System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further.

MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by e-mail dated October 31, 2005. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.

PRODUCT: S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers. Part #944-025, Recall # Z-1460-06

REASON: Calibration solution for ABL700 Blood Gas Analyzers is labeled with an incorrect bar code. The bar code identified on the Cal Solution 2 product is actually the bar code for the rinse solution.

MANUFACTURER: Recalling Firm: Konica Minolta Medical Imaging USA, Inc., Wayne, NJ, by telephone on July 14, 2006. Manufacturer: Konica Minolta Medical & Graphic, Inc., Tokyo, Japan. Firm initiated recall is terminated.

PRODUCT: Regius Model 370 Digital Radiography Konica Minolta, Recall # Z-1481-06

REASON: A hand grip column, even though locked in position, moved downward about 3 cm while a patient was holding the hand grip for lateral exposure. When the hand grip moved down, the patient who was holding it lost his or her balance and almost fell.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 6, 2006

CLASS II

MANUFACTURER: Recalling Firm: Guidant Corporation, Saint Paul MN, by letters dated June 23, 2006 and press release on June 26, 2006, FDA issued a statement on July 11, 2006. Manufacturer Firm: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.

PRODUCT: a) Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1466, 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide, Recall # Z-1293-06;b) Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The Intermedics NEXUS I Ultra (models 1390, 1490, 1491) are not available in the US. The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. Two sensors are available: these adapt the pacing rate to the patient's changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models can use either the accelerometer or minute ventilationsensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. Recall # Z-1294-06; c) Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (models1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Plus pacemakers are multiprogrammable pacemakers from Intermedics. The familyconsists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available: these adapt the pacing rate to the patient's changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Plus models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide, Recall # Z-1295-06;d) Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: VDD (model 1428), DDD (model 1432), SR (model 1392) and DR (model 1492). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I AVT pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. The INSIGNIA and NEXUS I Plus adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide. ****The following devices are not available in the US, Recall # Z-1296-06;e) Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Implantable cardioverter defibrillators (ICDs) are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy. Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. VENAK PRIZM 2 devices offer dual-chamber bradycardia features (atrial and /or ventricular pacing and sensing), and VENTAK PRIZM 2 VR devices offer single-chamber bradycardia features (ventricular pacing and sensing), Recall # Z-1297-06;f) CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK RENEWAL TR2 devices are not available in the US. The devices are designed to provide cardiac resynchronization therapy by providing biventricular electrical stimulation to synchronize the right and left ventricular contractions. The device also provides adaptive-rate bradycardia therapy. The pulse generator has independent, programmable outputs for the atrium, right ventricle and left ventricle, Recall # Z-1298-06;g) VITALITY (models 1870, 1871, T125, T127, T135) and VITALITY 2 (models T165, T167, T175, T177). Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tachyarrhythmias. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. Devices denoted with DR offer dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), and the devices denoted with VR offer single-chamber bradycardia features (ventricular pacing and sensing), Recall # Z-1299-06

REASON: Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion or loss of pacing output without warning in the affected devices.

MANUFACTURER: Bayer Healthcare, LLC (Diagnostics Division), TarrytownNY, by Support Bulletins on March 16, 2006. Firm initiated recall is ongoing.

PRODUCT: ADVIA 2120 systems --Automated Complete Blood Cell and Differential Cell Counter, Recall # Z-1376-06

REASON: The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an abnormal baso cytogram.

MANUFACTURER: Recalling Firm: Radiometer America Inc, WestlakeOH, by letter dated February 2, 2005. Manufacturer Firm: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.
PRODUCT: TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor), Recall # Z-1437-06

REASON: Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped.

MANUFACTURER: Biogenex Laboratories, San RamonCA, by letters on June 5, 2006. Firm initiated recall is ongoing.

PRODUCT: a) BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP, Recall # Z-1438-06; b) BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and MU364-UC, Recall # Z-1439-06

REASON; Misbranding-The product labeling (label and insert) is misbranded in that the product does not comply with the labeling requirements for an Analyte Specific Reagent (ASR).

MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letter the week of May 15, 2006. Firm initiated recall is ongoing.

PRODUCT: UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems, Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4, Recall # Z-1440-6

REASON: Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show 'Days Left' as 21. The correct Reagent Status for a new Lithium reagent cartridge is 14 days. Lithium reagent used past 14 days may produce low quality control and/or patient results.

MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc., Parsippany NJ, by letter on July 18, 2006. Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is ongoing. 

PRODUCT: Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay, Recall # Z-1441-06

REASON: Decrease in sensitivity; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.

MANUFACTURER: Recalling Firm: Radiometer America Inc, WestlakeOH, letter on June 29, 2006. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.

PRODUCT: SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary tube kits as follows: Clinitubes Kits: 942-890 (D941P-240-85x1), Lot Code: R0048; Clinitubes Kits: 942-892 (D957P-70-100x1), Lot Codes: R0045 through R0050; Clinitubes Kits: 942-893 (D957P-70-125x1), Lot Codes: R0058 through R0063; Clinitubes Kits: 942-898 (D957P-70-70x1), Lot Code: R0019. Each of the kits listed above contains one (1) bag of Capillary Caps, 905-787, Recall # Z-1442-06

REASON: Leaking Capillary Caps- The dimensions and shapes of the capillary caps do not fit the capillary tubes correctly. This can cause the capillary tubes to leak.

MANUFACTURER: Recalling Firm: Radiometer America Inc, WestlakeOH, letter on July 18, 2006. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.

PRODUCT: safePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and each box contains 100 pouches. The product subject to recall is identified with the following Part Numbers/Order No: 956-610, 956-612, 956-614, 956-616, and 956-623, Recall # Z-1443-06

REASON: Leaking Tip Caps- Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.

MANUFACTURER: Recalling Firm: Delphi Medical Systems, TroyMI, by letter dated March 29, 2005. Manufacturer: Delphi Medical Systems Colorado Operations, LongmontCo. firm initiated recall is ongoing.

PRODUCT: Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8, Recall # Z-1445-06

REASON: Potential for under-infusion without alarm; Cassette rollers stop moving , but the pump shaft continues rotating without alarm.

MANUFACTURER: Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letter on July 1, 2005. Manufacturer: Becton Dickinson Caribe, Ltd., San Lorenzo, PR. Firm initiated recall is complete.

PRODUCT: BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Recall # Z-1446-6

REASON: Formulation problems. Lower pH of the solutions may increase Red Blood Cell hemolysis.

MANUFACTURER: Bayer Healthcare, LLC (Diagnostics Division), TarrytownNY, issued a Support Bulletin on/about February 17, 2006. Firm initiated recall is ongoing.

PRODUCT: a) ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer -- human serum, plasma and urine tests, Recall # Z-1448-06; b) ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer -- human serum, plasma and urine tests, Recall # Z-1449-06; c) ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer -- human serum, plasma and urine tests, Recall # Z-1450-06

REASON: Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or - Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as --25%). PHNY was determined to also exhibit a similar carryover effect on CARB. All others were found not to produce the same reagent probe-based carryover effect.

MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letter dated June 12, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Product Description: Liquid AutoHDL Cholesterol Reagent Set, Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Recall # Z-1454-06;b) AutoHDL Cholesterol Reagent Set for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Imported and Marketed in India; Catalogs HH7545-80, Recall # Z-1455-06, c) AutoHDL Cholesterol R1 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Catalogs HH445-R1, Recall # Z-1456-06; d) AutoHDL Cholesterol R2 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Catalogs HH445-R2, Recall # Z-1457-06; e) Auto HDL reagent, sold by Pointe Scientific; Catalog no. 3-H7545-L, Recall # Z-1458-06;. f) Auto HDL Cholesterol reagent in bottles of 320 ml and 1000 ml, Catalog nos. 7-H7545-320 and 7-H7545-1000, Recall # Z-1459-06

REASON: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

MANUFACTURER: Bayer Healthcare, LLC (Diagnostics Division), TarrytownNY, by e-mail on April 4, 2006. Manufacturer: Bayer Healthcare, LLC Diagnostics Division, NorwoodMA. Firm initiated recall is ongoing.

PRODUCT: a) RapidLab® 1200 Systems, Model 1245-Blood gases, electrolyte and blood pH test system, Part No. 05061537, Recall # Z-1464-06;b) RapidLab® 1200 Systems, Model 1265- Blood gases, electrolyte and blood pH test system, Part No. 05063769; Recall # Z-1465-06

REASON: Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab® 1245 or RapidLab® 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink®, or Rapidcomm(tm) data management system. 

CLASS III

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by telephone and letter dated July 21, 2006. Firm initiated recall is ongoing.

PRODUCT: Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911, 912, 917, Modular and Cobas c 501 clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/US #722-4402, Recall # Z-1447-06

REASON: Expired product (dated 2006.06) was shipped as replacement for recalled product.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 30, 2006:

CLASS II

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated June 30, 2006. Firm initiated recall is ongoing.
PRODUCT: a) Terumo Advanced Perfusion System 1 Roller Pump
6 inch diameter, Catalog No. 801041, Recall # Z-1403-06;
b) Terumo Advanced Perfusion System 1 Roller Pump
4 inch diameter, Catalog No. 801040, Recall # Z-1404-06;
c) Terumo Advanced Perfusion System 1 Integrated Centrifugal
System Control Unit, Catalog No. 801046, Recall # Z-1405-06
REASON: The manual roller pump speed control knob may fail to function/change pump speed.

MANUFACTURER: Steris Corporation, Montgomery, AL, by letter on June 22, 2006. Firm initiated recall is ongoing.
PRODUCT: a) Steris Amsco Sonic Energy Cleaner, Part Nos.:
P080000005, B018905020, B018905JBJ, and
B018905JBJSS, Recall # Z-1407-06;
b) Amsco Sonic Energy Console, Part Nos.: B602047470,
P080000002, P080000003, B018905015, B018905016,
B018905017, B018905018, B018905JAE, B018905JAESS,
B018905JAESSI, B018905JAG, B018905JAGSS,
Recall # Z-1408-06.
REASON: Smoke, sparking and fire hazard -- Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking and fire.

MANUFACTURER: Recalling Firm: INO Therapeutics, Inc., Clinton, NJ, by letter on July 5, 2005 and by email and telephone on July 7, 2006. Manufacturer: Datex -- Ohmeda, Inc., Madison, WI. Firm initiated recall is ongoing.
PRODUCT: INOvent, Nitric Oxide Delivery System, Model Number 1605-9000-000, Recall # Z-1410-06.
REASON: The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.

MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated July 20, 2006. Manufacturer: Zimmer Trabecular, Allendale, NJ. Firm initiated recall is ongoing.
PRODUCT: a) Zimmer Trabecular Metal Reverse Shoulder System
Glenosphere, 36 mm diameter, Catalog/Ref No.
00-4349-036-01, Recall # Z-1416-06;
b) Zimmer Trabecular Metal Reverse Shoulder System
Glenosphere, 40 mm diameter, Catalog/Ref No.
00-4349-040-04, Recall # Z-1417-06;
c) Zimmer Trabecular Metal Reverse Shoulder System
Base Plate; Catalog/Ref No. 00-4349-038-00,
Recall # Z-1418-06
REASON: Components may not lock together as intended.

MANUFACTURER: Recalling Firm: BioCare Systems, INC., Parker, CO, by telephone beginning June 8, 2006, followed by a letter on June 23, 2006. Manufacturer: Cui Stack, Inc., Beaverton, OR. Firm initiated recall is ongoing.
PRODUCT: LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, Recall # Z-1419-06.
REASON: Electrical Safety Hazard-when pulling on the cord of the AC adapter, to remove it from an outlet, the prongs on the AC adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard.

MANUFACTURER: A & E Industries, Ltd., Guangdong, Chin, by letter on June 30, 2006. Firm initiated recall is ongoing.
PRODUCT: a) Guardian Walker, Models 30751W, 30757W, 30758W,
Recall # Z-1420-06;
b) Guardian 5 inch Walker Wheel Kits, Model Numbers:
07722-8, 07722G, 07722-5, 07722-8B, 07725, Recall # Z-1421-06.
REASON: Walker wheel hubs may fracture, causing walker to collapse to one side.

MANUFACTURER: Recalling Firm: COBE Cardiovascular, Inc, Arvada, CO, by Letter on June 26, 2006. Manufacturer: Senior Operations, Inc., Bartlett, IL. Firm initiated recall is ongoing.
PRODUCT: a) Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile,
(Standalone Systems) Catalog Numbers 050255500, 050316400,
050412400, 050500000, Recall # Z-1422-06;
b) Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile,
(Standalone systems). Catalog Numbers: 050226400, 050422400,
Recall # Z-1423-06;
c) Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile,
(Standalone systems), Catalog numbers:050125400, 050502000,
Recall # Z-1424-06;
d) Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile,
(Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001,
067129002, 067149006, 067174002, 067188002, 067212004, 067221009,
067236004, 067260001, 067296002, 067351006, 067354002, 067388004,
067434005, 067442001, 067447010, 067452001, 067458005, 067481003,
06748002, 067523001, 067529002, 067536002, 067539005, 067570003,
067577001, 067594003, 067602001, 067614005, 067625001, 067634005,
067662002, 067668001, 067682001, 067683003, 067686005, 067694002,
067709001, 067710001, 067714001, 067721002, 067722001, 067735002,
078011601, 078011701, 078014002, 078107009, 078149017, 078183015,
078196012, 078249006, 078280017, 078346013, 078351010, 078399009,
078439012, 078522010, 078534012, 078541004, 078549011, 078574008,
078707005, 078766004, 078892004, 078898003, 078909002, 0789337004,
078959005, 078987001, 078988002, 07896006, Recall # Z-1425-06;
e) Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile,
(Custom Heart/Lung Packs), Catalog numbers: 067100001, 078002103,
078005802, 078159025, 078201013, 078212009, 078310006, 078332022,
078348014, 078428010, 078688007, 078869003, Recall # Z- 1426-06;
f) Cobe Optimin Hollow Fiber Sealed System, Sterile,
(Custom Heart / Lung Pack), Catalog Numbers: 067350004,
067734001, 067736002, Recall # Z-1427-06;
g) Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile,
Catalog Number 436422974, (shipped International only for use in
Heart/Lung packs), Recall # Z-1428-06;
h) Cobe CML Duo Flat Sheet Membrane Oxygenator, Non-sterile,
Catalog Number: 436122974, (shipped international only for use in
Heart/Lung Packs), Recall # Z-1429-06.
REASON: Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metallic material, thus decreasing the surface area needed for proper heat transfer.

MANUFACTURER: Recalling Firm: Nellcor Puritan Bennett, Pleasanton, CA, by letters on July 12, 2006. Manufacturer: MMJ S. A. de C.V., Cd Juarez, Mexico. Firm initiated recall is ongoing.
PRODUCT: Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, shipped in cases of 20, Model number 85863, Recall # Z-1431-06.
REASON: Product's outer sheath material may separate from the wire interior during use and may lodge in the endotracheal tube or enter the patient's airway and interfere with ventilation.

MANUFACTURER: Conmed Corporation, Utica, NY, by letters dated March 27, 2006, by facsimile and/or e-mail. Firm initiated recall is ongoing.
PRODUCT: a) ConMed DetachaTip Multi-Use Laparoscopic Instrument, "Fenestrated
(Duckbill) Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1008.
The product is distributed sterile in heat-sealed tray and labeled with an
expiration date that pertains only to the sterility, Recall # Z-1433-06;
b) ConMed DetachaTip Multi-Use Laparoscopic Instrument, "Endoweave
Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1028.
The product is distributed sterile in heat-sealed tray and labeled with an
expiration date that pertains only to the sterility, Recall # Z-1434-06
REASON: Grasper jaws breaking at the junction of the jaw and tube during Laparoscopic procedures.

MANUFACTURER: MicroVision Medical Holding B.V., Amsterdam, Netherlands, by letter dated July 21, 2006. Firm initiated recall is ongoing.
PRODUCT: MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVision Medical brand, Recall # Z-1435-06.
REASON: Some lenses may have microscopic holes in the disposable caps representing a potential break in the sterile barrier.
CLASS III
MANUFACTURER: Ciba Vision Corporation, Duluth, GA, by letter on July 25, 2006. Firm initiated recall is ongoing.
PRODUCT: Focusâ * DAILIESâ * Toric * One-Day Contact Lenses * CIBA Vision, Recall # Z-1402-06.
REASON: Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50).

MANUFACTURER: Recalling Firm: Radiometer America, Inc., Westlake, OH, by letter dated January 12, 2005. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
PRODUCT: D7120, BG-OX Cartridge, D7120 REF 946-003, cuvettes for the NPT7 series of blood gas analyzers, Recall # Z-1406-06.
REASON: QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.

MANUFACTURER: Recalling Firm: Wako Chemicals, USA Inc., Richmond, VA, by telephone and e-mail letter dated July 6, 2006. Manufacturer: Wako Pure Chemical Industries Ltd., Osaka, Japan. Firm initiated recall is ongoing.
PRODUCT: Lp(a) Calibrator, Catalog No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box, Recall # Z-1409-06.
REASON: Unexpected low cholesterol results. The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value.

MANUFACTURER: Sunrise Medical CCG, Inc., Stevens Point, WI, by telephone on November 16, 2005. Firm initiated recall is complete.
PRODUCT: a) Joerns Easy Care 2000, Model B784, Manual adjustable
Hospital Bed, Recall # Z-1411-06;
b) Joerns Easy Care 2003 bed, Model B684,
Joerns Easy Care 2003 DC bed, Model B684DC,
Joerns Easy Care 2100, Model B694 AC-powered adjustable
Hospital Bed, Recall # Z-1412-06.
REASON: Malfunction. The Easy care drive system performance, controlling back and knee section angle adjustment, as well as, bed height adjustment could become non-functional.

MANUFACTURER: Recalling Firm: Richard Wolf Medical Instruments Corp., Vernon Hills, IL, by telephone on July 7, 2006 Manufacturer: V. Krutten Gmbh, Idstein, Germany. Firm initiated recall is ongoing.
PRODUCT: Tubing Set for TEM-Combined System, the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube, a sterile, disposable, single use accessory to the TEM (Transanal Endoscopic Microsurgery) System used for insufflation of the rectal cavity. Part number: 4170.801, Recall # Z-1430-06.
REASON: The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.
MANUFACTURER: ConvaTec, Skillman, NJ, by letter, on July 13, 2006. Firm initiated recall is ongoing.
PRODUCT: Active Life Non-Convex Drainable Stomahesive pouch-1 ¼" (32 mm), Product No. 022766, UPC: 30003-022766, Recall # Z-1432-06
REASON: Cartons labeled 1-1/4 inch size may contain units that are 1-1/2 inch size.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 23, 2006:

CLASS II

MANUFACTURER: Boston Scientific Corp., Spencer, IN, by letters dated June 2, 2006. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No. 820-100, UPN Product No. (M0068201000), Recall # Z-1309-06
REASON: The packages are labeled sterile, but the product was not sterilized.

MANUFACTURER: Edwards Lifesciences Llc, Irvine, CA, by telephone and letter dated July 7, 2006. Firm initiated recall is ongoing.
PRODUCT: Edwards Vigilance Monitors (Formerly Baxter Vigilance Monitors). Patient monitor which measures cardiac output. Models: VG, VGS, VGS1, VGS2, VG2, & IVM, Recall # Z-1310-06
REASON: Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user to this situation. This can result in overheating and thermal damage to the CCO catheter and serious patient injury.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated July 14, 2006. Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.
PRODUCT: Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717, 747, 902, 911, 912, 917, Modular and cobas c 501 clinical chemistry analyzers. Roche Catalog/Part Number 10825441001/US # 722-4402, Recall # Z-1352-06.
REASON: A design change in the electrodes will result in incorrect potassium level results.

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co., Phillips, Bothell, WA, by letter on July 1, 2006. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
PRODUCT: Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option, Recall # Z-1353-06
REASON: Potential for measurements, lines, texts, etc to be stored incorrectly. Any added arrow will point to the wrong anatomical structure and this will make the image useless in combination with reported findings.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated June 22, 2006. Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany. Firm initiated recall is ongoing.
PRODUCT: a) ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose
Monitoring System; Cat. no. 870. Ref. no. 080087000 with meter
model number 870; Ref. no.0353756001 with meter model number
33304510; Ref. no. 03537536001 with meter model no. 2138930;
Ref. no. 03537536001 with meter model no. 3288650, Recall # Z-1354-06;
b) ACCU-CHEK Advantage Complete Diabetes Monitoring Kit,
Cat. No. 860. Ref. no. 080086000 with meter model number 870;
Ref. no. 03002531001 with meter model number 33304510;
Ref. no. 03002531001 with meter model number 2138930;
Ref. no. 03002531001 with meter model number 2138930,
Recall # Z-1355-06;
c) ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 2137500;
Ref. no. 0385633001 with meter model no. 768, Recall # Z-1356-06;
d) ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 3332586;
Ref. no. 03332586001 with meter model no. 2138930, Recall # Z-1357-06;
e) ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001
and 12139642001 both with meter model number 2138930, Recall # Z-1358-06;
f) ACCU-CHEK Comfort Curve. Cat. No. 3149030; Ref. number 0314903001
with meter model number 2138930, Recall # Z-1359-06;
g) ACCU-CHEK Advantage (Managed Care Kit) 100- value memory
with time and date, Not for Retail Sale, Cat. No. 3000389; Ref no.
03000389001 with meter model no. 2138930, Recall # Z-1360-06;
h) ACCU-CHEK Advantage (Conversion Kit),Cat. no. 3000338;
Ref no. 03000338001 with meter model no. 2138930, Recall # Z-1361-06;
i) ACCU-CHEK Advantage (Consignment kit), Cat. no. 3000320; catalog
no. 03000320001 with meter model no. 2138930, Recall # Z-1362-06;
j) ACCU-CHEK Complete diabetes monitoring kit/ care kit/ insulin pump
therapy kit, Cat. no 515; Ref. nos. 03144852001 and 12031981001
with meter model no. 200 and Ref. no. 03144852001 with meter
model no. 250, Recall # Z-1363-06;
k) ACCU-CHEK Complete blood glucose monitor, Ref. no. 516;
Catalog nos. 03266770001 and 03871983001 with meter model
no. 200 and Catalog no. 03871983001 with meter model number
250, Recall # Z-1364-06;
l) ACCU-CHEK HQ for Blood Glucose Monitoring and Automated
Data Management and Communication; Contents include two
Accu-Chek Advantage monitors including Cat. no. 2138018 and
Cat. no. 2138026. Ref. nos. 12138018001 and 12218542001 both
include meters with model number 777, Recall # Z-1365-06;
m) AccuData GTS Plus for Blood Glucose Monitoring and Automated
Data Management including GTS Plus with Accu-Chek Advantage
blood glucose meter, Cat no. 3000249 and/or GTS with Accu-Chek
Advantage blood glucose meter, Cat. no. 404, and/or Replacement
GTS with Accu-Chek Advantage blood glucose meter, Cat. no. 404R,
and/or Replacement Base Unit with Advantage Module, Cat. no.
3426050. Ref. nos. 030002490001 and 03136833001 both have meters
with model no. 777, Recall # Z-1366-06;
n) AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring
and Automated Data Management, contents Accu-Chek Advantage
replacement Meter and module, cat. no. 454; Ref. no. 03144798001
contains meter model no. 777, Recall # Z-1367-06;
o) GTS Advantage Meter. Cat. no. 424. Ref. no. 03144780001 with meter
model no. 777, Recall # Z-1368-06;
p) ACCU-CHEK Advantage FPO Diabetes Monitoring Kit, Cat. no.
3271358001. Ref. no. 03271358001 with meter model no. 3288650,
Recall # Z-1369-06;
q) ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and
Voice Unit - English language version for the blind or visually impaired,
Cat. no 2030802. Ref. no. 12030802001 with meter model no. 768,
Recall # Z-1370-06;
r) ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter
and Voice Unit - Spanish language version for the blind or visually
impaired, Cat. no. 3040208. Ref. no. 03040208001 with meter model no.
768, Recall # Z-1371-06
REASON: The meter gives an error message that can actually mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that the test strip may be damaged or test was not performed correctly.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated July 17, 2006. Manufacturer: Precision System Science Co., Ltd., Chiba, Japan. Firm initiated recall is ongoing.
PRODUCT: a) Roche MagNA Pure LC System (RMD); Catalog no. 03670325001.
An automated, general purpose instrument for isolation and purification of
nucleic acids and assembly of PCR reactions. Recall # Z-1372-06;
b) Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. .
An automated, general purpose instrument for isolation and purification of
nucleic acids and assembly of PCR reactions. Recall # Z-1373-06;
c) Roche MagNA Pure LC Instrument; Catalog nos. 12236931692 (Refurbished)
and 12236931690 (Return). An automated, general purpose instrument for
isolation and purification of nucleic acids and assembly of PCR reactions.
Recall # Z-1374-06;
REASON: If the user opens the instrument lid during decontamination, the cycle will stop, but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not.
MANUFACTURER: Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on September 20, 2005. Firm initiated recall is ongoing.
PRODUCT: Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators, Recall # Z-1375-06.
REASON: A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letter dated June 28, 2006. Firm initiated recall is ongoing.
PRODUCT: a) Accu-Chek Comfort Curve blood glucose test strips; (packaged in 10s, 50s,
and/or 100s) U.S. Reference nos. 12030420001, 12030373001, 12030381001,
12030365001, 04388208001, 04388186001 and 03000141001,
Recall # Z-1377-06;
b) Accu-Chek Advantage blood glucose test strips; U.S. Reference nos.
(packaged in 50s and/or 100s) 03144917001, 03144704001, 03145263001
and International Reference nos. 12030551001, 12030578001 and 12030586001,
Recall # Z-1378-06;
c) Accu-Chek Advantage II blood glucose test strips; International Reference nos.
12030659001, 12030667001, 03137872001, 03137899001, 03000281001,
12030535001, 12030543001, 03033449001, 03033465001 and 12030543047,
Recall # Z-1379-06;
d) Accu-Chek Sensor Comfort blood glucose test strips; International Reference nos.
03261956170, 03261964170, 03146154192, 03146146192, 03374700023,
03374718023, 11895133192, 11895141192, 03522091016, 03051161003,
03051170003, 03322033122, 03322041122 and 03587304122, Recall # Z-1380-06;
e) Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference
nos. 03758770001, 03360652080, 03051188003, 03620115003, and 04535235003,
Recall # Z-1381-06;
f) Accu-Chek Advantage Plus blood glucose test strips; International Reference no.
04735102001, Recall # Z-1382-06;
g) Accu-Chek Advantage Pro blood glucose test strips; International Reference no.
04534972001, Recall # Z-1383-06;
h) Accu-Chek Inform blood glucose test strips; International Reference nos.
04535057001, 04647696001 and 04535120001, Recall # Z-1384-06
REASON: The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated July 25, 2006. Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
PRODUCT: Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216), Recall # Z-1385-06
REASON: The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results).

MANUFACTURER: Recalling Firm: Radiometer America Inc., WestlakeOH, by letter dated September 29, 2005. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
PRODUCT: a) Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series,
manufactured from 8/1998 through 11/2004, Recall # Z-1386-06;
b) Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-800 Series,
manufactured from 8/2004 through 9/2005, Recall # Z-1387-06
REASON: Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na).

MANUFACTURER: Pointe Scientific, Inc., Lincoln Park, MI, by letter dated June 9, 2006. Firm initiated recall is ongoing.
PRODUCT: a) Liquid Alkaline Phosphatase Reagent Set for the quantitative determination of
alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.;
Catalog nos. A7516-150, A7516-450, A7516-625, HA716-246, HA716-2400,
HA916-302 and HA916-492. In vitro diagnostic, Recall # Z-1388-06;
b) Liquid Alkaline Phosphatase (R1) Reagent Set for the quantitative determination
of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.;
Catalog no. H A416-R1. In vitro diagnostic; Recall # Z-1389-06;
c) Liquid Alkaline Phosphatase (R2) Reagent Set for the quantitative determination
of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.;
Catalog no. H A416-R2. In vitro diagnostic, Recall # Z-1390-06;
d) Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic
Technologies LLC, Caldwell, N.J. in 8.4 mL and 30 mL containers. In vitro
diagnostic, Recall # Z-1391-06;
e) Alkaline Phosphatase Substrate Mfg. for Alfa Wassermann Diagnostic
Technologies LLC, Caldwell, N.J. in 2.1 mL and 7.5mL containers. In vitro
diagnostic, Recall # Z-1392-06;
f) Liquid Alk Phos Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-L.
In vitro diagnostic, Recall # Z-1393-06;
g) Liquid Alk Phos R1 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R1.
In vitro diagnostic, Recall # Z-1394-06;
h) Liquid Alk Phos R2 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R2.
In vitro diagnostic, Recall # Z-1395-06;
i) Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent in 50 ml,
120 ml, 2 L and 500 ml containers, sold by Pointe Scientific; Catalog nos.
7-HA716-R1-50-917, 7-A7516-R1-120, 7-A7516-R1-2L, 7-A7516-R1-500,
7-HA716-R1-500, 8-A7516-R1-120 and 8-A7516-R1-500. In vitro diagnostic,
Recall # Z-1396-06;
j) Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml,
90 ml, 125 ml and 400 ml containers, sold by Pointe Scientific; Catalog nos.
7-A7516-R2-125, 7-A7516-R2-30, 7-A7516-R2-400ML, 7-A7516-R2-90,
8-A716-R2-125, 8-A7516-R2-30 and 8-A7516-R2-90. In vitro diagnostic,
Recall # Z-1397-06
REASON: The reagent may be contaminated with microorganisms.

MANUFACTURER: Recalling Firm: Varian Medical Systems, CharlottesvilleVA, by letter on 4/17/06 and continuing through 5/1/06. Manufacturer: Varian Medical Systems, Haan, Germany. Firm initiated recall is ongoing.
PRODUCT: a) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst
and vers.-row, part number GM11005400, for the GammaMed model 12i
radionuclide applicator system, Recall # Z-1398-06;
b) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst
and vers.-row , part number GM11005400, for the GammaMed model 12it
radionuclide applicator system, Recall # Z-1399-06
REASON: Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc, ConcordCA, by letter on June 22, 2006. Manufacturer: Impac Medical Systems Inc, Mountain View,CA. Firm initiated recall is ongoing.
PRODUCT: LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface, Recall # Z-1401-06
REASON: Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format.

CLASS III

MANUFACTURER: Recalling Firm: Radiometer America Inc., WestlakeOH, by E-Mail on September 19, 2005, and by telephone on or around September 20, 2005.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
PRODUCT: a) Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode
Part Number: 945-603, distributed one (1) electrode per box, Recall # Z-1323-06;
b) Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode
Part Numbers: 945-633, distributed one (1) electrode per box, Recall # Z-1324-06
REASON: Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.

MANUFACTURER: Recalling Firm: ABX Diagnostics, Inc., Irvine, CA, by letter and telephone on March 24, 2006. Manufacturer: Horiba ABX, Montpellier, France. Firm initiated recall is ongoing.
PRODUCT: ABX Pentra 120, 120R, 120DX, automated hematology analyzer, Recall # Z-1334-06
REASON: Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.

MANUFACTURER: Recalling Firm: Invacare Corp., Elyria, OH, by letter dated June, 2006. Manufacturer: Viscount Vehicle Co. LTD, Taiwan, Republic of China. Firm initiated recall is ongoing.
PRODUCT: Pronto M51 Wheelchair, component-seat, Recall # Z-1400-06
REASON: Some of the wheelchairs were distributed with seats that did not have a seat positioning strap.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 16, 2006:

CLASS II

MANUFACTURER: Medisurg Research & Management Corp, NorristownPA, by fax on April 28, 2006. Firm initiated recall is ongoing.
PRODUCT: Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped 12 units per carton. Recall # Z-1224-06
REASON: No documentation to support shelf life/sterility

MANUFACTURER: Recalling Firm: Abbott Diabetes Care, Inc. AlamedaCA, by letters on May 22, 2006. Manufacturer: Flextronics International, Shenzhen, China, Firm initiated recall is ongoing.
PRODUCT: a) Abbott brand FreeStyle Blood Glucose Meter, Recall # Z-1306-06
b) Abbott brand FreeStyle Flash Blood Glucose Meter, Recall # Z-1307-06
REASON: The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure, and strip calibration code.

MANUFACTURER: Tekia, Inc., Irvine, CA, by telephone, on July 2, 2004 and July 8, 2004. Firm initiated recall is ongoing.
PRODUCT
TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL) :
1a) Products labeled with TEKIA as manufacturer: IOLs with power of 17.0 D;
1b) IOLs with power of 22.5 D;
2a) Products labeled with Polytech as manufacturer: IOLs with power of 17.0 D:
2b)IOLs with power of 22.5 D, Recall # Z-1311-06
REASON: Intraocular lenses (IOLs) with power of 17.0 D and 22.5 D are mislabeled with each other's labels.

MANUFACTURER: Recalling Firm: Arthrocare, Corp., Sunnyvale, CA, by letters on June 29, 2006. Manufacturer: Arthrocare, Corp., Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.
PRODUCT: OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in placement of sutures through soft tissue in endoscopic and other limited access procedures., Catalog number OM-6006. This catalog number is referred to as the OPUS MiniPlus Implant Set, Recall # Z-1312-06
REASON: The product may lose sterility due to omission of the final pouch seal.

MANUFACTURER: Recalling Firm: Radiometer America Inc, WestlakeOH, by letter on June 17, 2005 Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.
PRODUCT: a) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer,
ABL-700 series, Recall # Z-1317-06;
b) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer,
ABL-800 series, Recall # Z-1318-06
REASON: Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.

MANUFACTURER: Recalling Firm: Radiometer America Inc, WestlakeOH, by letter on June 9, 2005 Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.
PRODUCT: ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Recall # Z-1320-06
REASON: The dimensions and shape of the analyzer adaptor do not fit the analyzer tubes or probe, causing air to be aspirated with the blood sample and causing a deviation in the p02 sample results.

MANUFACTURER Recalling Firm: Radiometer America Inc, WestlakeOH, by letter on March 22, 2006 Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
PRODUCT: a) Capillary (end) caps, accessory for use with blood gas analyzers included in
Radiometer's CLINITUBES kits. The end caps are packaged in bags.
These bags are placed in the capillary tube kit which also contains: capillary tubes,
end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending
on the kit model. Each bag contains: 110 Green caps per bag and 160 Red caps per bag,
Recall # Z-1321-06;
b) Capillary (end) caps, accessory for use with blood gas analyzers included in
Radiometer's CLINITUBES kits. The end caps are packaged in bags.
These bags are placed in the capillary tube kit which also contains: capillary tubes,
end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on
the kit model. Each bag contains: 110, Recall # Z-1322-06
REASON: Capillary end caps, an accessory for ABL blood gas analyzers, leak blood from capillary tubes during transport.

MANUFACTURER: Pointe Scientific, Inc., Lincoln Park, MI, by letter dated June 7, 2006. FDA initiated recall is ongoing.
PRODUCT: a) Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, for the quantitative
determination of glucose in serum, 5 x 600 ml R1 glucose HEX, for use with Hitachi
analyzer; in vitro diagnostic, Catalog number HG420-R1, Recall # Z-1326-06;
b) Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, for the quantitative
determination of glucose in serum, 5 x 600 ml R2 glucose HEX, for use with Hitachi
analyzer; in vitro diagnostic, Catalog number HG420-R2, Recall # Z-1327-06;
c) Pointe Scientific Liquid Glucose (HEX) Reagent Set, for the quantitative determination
of glucose in serum, 10 x 5 ml R1 and 5 x 20 ml R2, or 9 x 67 ml R1and 9 x 17 ml R2
glucose reagent, for use with Hitachi analyzer; in vitro diagnostic, Catalog numbers
HG720-600 and HG920-756, Recall # Z-1328-06;
d) Pointe Scientific Liquid Glucose (HEXO) Reagent Set, for the quantitative
determination of glucose in serum, 10 x 100 ml R1, 10 x 20 ml R2 glucose reagent,
or 1 x 2 L R1 x 500 ml R2, for use with Hitachi analyzer; in vitro diagnostic, Catalog
numbers HG920-1200 and HG920-2500, Recall # Z-1329-6;
e) Glucose Hex reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no.
3-HG920-L, Recall # Z-1330-06;
f) Glucose HEX reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no.
3-HG920-L, Recall # Z-1331-06;
g) Glucose HEX R1 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no’s
3-HG920-R1, 7-HG920-R1-67, 7-HG920-R1-600 and 7-HG920-R1-800,
Recall # Z-1332-06;
h) Glucose HEX R2 reagent sold by Pointe Scientific; in vitro diagnostic,
Catalog no’s 3-HG920-R2, 7-HG920-R2-17, 7-HG920-R2-200 and 7-HG920-R2-300,
Recall # Z-1333-06
REASON: Product does not meet performance specification through its labeled expiration period.

MANUFACTURER: Recalling Firm: Zimmer Caribe, Inc., Warsaw, IN, by letters letter dated June 26, 2006 and June 28, 2006. Firm initiated recall is ongoing.
PRODUCT: a) Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head,
52.5 mm length, 22-13-5 stainless steel, sterile bone screw;
Cat. no. 2253-52-45 (00225305545), Recall # Z-1335-06;
b) Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm
hex head, 55 mm length, 22-13-5 stainless steel, sterile bone screw;
Cat. no. 2253-55-45 (00225305545), Recall # Z-1336-06;
c) Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head,
65 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-65-45
(00225306545), Recall # Z-1337-06;
d) Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head,
70 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-70-42
(00225307042), Recall # Z-1338-06;
e) Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head,
70 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-70-55
(00225307055), Recall # Z-1339-06;
f) Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head,
75 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-75-42
(00225307542), Recall # Z-1340-05;
g) Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head,
85 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-85-42
(00225308542). Recall # Z-1341-06;
h) Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head,
95 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-95-55
(00225309555), Recall # Z-1342-06;
i) Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head,
100 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-100-55
(00225310055), Recall # Z-1343-06;
j) Zimmer Bone Screw, self tapping, 6.5 mm dia., 20 mm length, tivanium TI-6AL-4V
alloy, sterile, Catalog no. 6250-65-20 (00625006520), Recall # Z-1344-06;
k) Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia.,
30 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-30
(00662406530), Recall # Z-1345-06;
l) Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia.,
35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-35
(00662406535); Recall # Z-1346-06;
m) Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia.,
40 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-40
(00662406540); Recall # Z-1347-06;
n) Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia.,
25 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-25-05
(47115502505), Recall # Z-1348-06;
o) Zimmer Herbert Cannulated Bone Screw System Bone Screw, 6.5 mm dia.,
35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-35-07
(47115503507), Recall # Z-1349-06;
p) Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia.,
45 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-45-05
(47115504505); Recall # Z-1350-06;
q) Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia.,
50 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-50-05
(47115505005), Recall # Z-1351-06
REASON: Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.

CLASS III

MANUFACTURER: Recalling Firm: Radiometer America Inc, WestlakeOH, by telephone on June 17, 2005. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.
PRODUCT: D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers, Recall # Z-1319-06
REASON: The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.

MANUFACTURER: Recalling Firm: Radiometer America, Inc., Westlake, OH, by memo and visits beginning on October 31, 2005. Manufacturer: Radiometer Medical Aps, Bronshoj, Denmark. Firm initiated recall is complete.
PRODUCT: ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21, Recall # Z-1325-06
REASON: ABL800 Series Blood Gas Analyzer became inoperable when the restore default setup button was touched.

The following is condensed list of medical devices involved in recalls listed by