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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), Rec