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Showing 66321–66340 of 68218 results

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Zimmer Orthopaedic Surgical Products: Zimmer Orthopaedic Surgical Products, Disposable Cuff, Du...

The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.

FDAFeb 11, 2005Nationwide• Zimmer Orthopaedic Surgical Products

Philips Medical Systems Sales & Service Region No. America: Tomoscan

Potential for shift of reference lines.

FDAFeb 10, 2005Nationwide• Philips Medical Systems Sales & Service Region No. America

Baxter Healthcare Corp. Rt.: Baxter I-Pump Pain Management System infusion pump, produ...

Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump.

FDAFeb 10, 2005Nationwide• Baxter Healthcare Corp. Rt.

Zimmer Inc.: Zimmer brand fracture blade plate instrument Chisel, 95 d...

The engraved calibration lines are incorrectly specified, which will result in the user obtaining a reading that the chiseling removed material to a depth 10mm deeper than what was actually removed, thus guiding the user to select a blade plate that is longer than will fit.

FDAFeb 9, 2005Nationwide• Zimmer Inc.

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Maximo DR, model 7278 Single Chamber Implantabl...

Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.

FDAFeb 9, 2005Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Maximo VR, model 7232 Single Chamber Implantabl...

Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.

FDAFeb 9, 2005Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Marquis DR, model 7274 Dual Chamber Implantable...

Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.

FDAFeb 9, 2005Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic InSync III Marquis, model 7279 Dual Chamber Imp...

Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.

FDAFeb 9, 2005Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic InSync Marquis, model 7277 Dual Chamber Implant...

Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.

FDAFeb 9, 2005Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Marquis VR, model 7230 Single Chamber Implantab...

Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.

FDAFeb 9, 2005Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic InSync II Marquis, model 7289 Dual Chamber Impl...

Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.

FDAFeb 9, 2005Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic InSync III Protect, model 7285 Dual Chamber Imp...

Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.

FDAFeb 9, 2005Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Stryker Endoscopy: Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 3...

The device has the potential to overheat and cause patient burns during use.

FDAFeb 8, 2005Nationwide• Stryker Endoscopy

Stryker Howmedica Osteonics Corp.: Scorpio Total Knee Posteriorly Stabilized Femoral Compone...

Mislabeled: The labeling indicates a Scorpio PS Femoral Component, however, the device inside the package is actually a Scorpio CR Femoral Component.

FDAFeb 8, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Scorpio Total Knee Cruciate Retraining Femoral Component;...

Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component.

FDAFeb 8, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Dade Behring: MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; ...

There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.

FDAFeb 7, 2005IN, PR• Dade Behring

Lemaitre Vascular, Inc.: LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Vo...

Product sterility maybe compromised due to defective packaging

FDAFeb 7, 2005AL, CA, FL +5 more• Lemaitre Vascular, Inc.

Unknown Manufacturer: Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1

The tip may separate from the device and render it unusable

FDAFeb 7, 2005AZ, CA, CO +18 more

Ups Supply Chain Solutions: RAPID SYPHILIS TEST KIT, per insert, contents of the kit ...

The kits are not approved for use in the United States.

FDAFeb 4, 2005Nationwide• Ups Supply Chain Solutions

Bausch & Lomb Inc: SofLens 66 Toric Visibility Tinted Contact Lenses for Dai...

Portion of lot contains lenses with incorrect refractive power.

FDAFeb 4, 2005Nationwide• Bausch & Lomb Inc

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