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Showing 68061–68080 of 68218 results

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Guidant Corp-Cpi Division: Discovery II Multiprogrammable Pacemaker, DDD Model 981

In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.

FDAMay 6, 2003Nationwide• Guidant Corp-Cpi Division

Guidant Corp-Cpi Division: Meridian Multiprogrammable Pacemaker, DDDR Model 1275

In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.

FDAMay 6, 2003Nationwide• Guidant Corp-Cpi Division

Guidant Corp-Cpi Division: Insignia Plus Multiprogrammable Pacemaker, DDD Model 985

In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.

Moderate

FDAMay 6, 2003Nationwide• Guidant Corp-Cpi Division

Guidant Corp-Cpi Division: Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1296

In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.

FDAMay 6, 2003Nationwide• Guidant Corp-Cpi Division

Guidant Corp-Cpi Division: Contak TR Multiprogrammable Pacemaker, DDDR Model 1241

In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.

FDAMay 6, 2003Nationwide• Guidant Corp-Cpi Division

Cryolife Inc: CryoValve Allograft, Pulmonary Heart valve & Conduit.

Microorganisms were detected in associated allografts after initial release of donor.

FDAMay 5, 2003CA, IN• Cryolife Inc

Cryolife Inc: CryoValve Allograft, Aortic Valve & Conduit

Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy.

FDAMay 5, 2003CA, IN• Cryolife Inc

Hill-Rom Manufacturing, Inc.: CLINITRON CII Air Fluidized Therapy unit.

Malfunction of side-rail latching pin coupled with inadequate directions for use.

FDAMay 5, 2003Nationwide• Hill-Rom Manufacturing, Inc.

Hill-Rom Manufacturing, Inc.: CLINITRON UP-LIFT Air Fluidized Therapy unit.

Malfunction of side-rail latching pin coupled with inadequate directions for use.

FDAMay 5, 2003Nationwide• Hill-Rom Manufacturing, Inc.

Cordis Corporation: Product is Cordis Brite Tip Catheter Sheath Introducer (4...

Reports of broken or separated tips of the catheter sheath introducers.

FDAMay 5, 2003Nationwide• Cordis Corporation

Smith and Nephew Wound Management (La Jolla): Dermagraft, Human Fibroblast -Derived Dermal Substitute, ...

Did not meet finished device specifications for the DNA criteria.

FDAMay 2, 2003Nationwide• Smith and Nephew Wound Management (La Jolla)

Magnivision, Inc.: Product is Magnivision UltraLights reading glasses which...

Possibility of eye injury from large temple tags on promotional sale product when customer tries them on in store.

FDAMay 2, 2003FL, IN• Magnivision, Inc.

System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140: System O2, Portable Humidified Oxygen Delivery System Ove...

System O2 oxygen flow rate found to be inadequate and RejuvO2 Home Oxygen Bar contains 'Adulterated Labeling.'

FDAMay 1, 2003GA, IN• System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140

System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140: Rejuv O2 Home Oxygen Spa 98% + Pure, Non-pressurized Oxy...

System 02 oxygen flow rate found to be inadequate and Rejuv02 Home Oxygen Bar contains 'Adulterated Labeling.'

FDAMay 1, 2003GA, IN• System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140

Stryker Medical: Stryker Secure II hospital bed; model 3002.

A wire may break at the crimp and present a potential electric shock hazard.

FDAMay 1, 2003KS, PA• Stryker Medical

Medegen Medical Products, LLC: GENT-L-KARE STERILE MID-STREAM URINE COLLECTOR

Finished products were not sterilized.

FDAApr 30, 2003Nationwide• Medegen Medical Products, LLC

Medegen Medical Products, LLC: GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE

Finished products were not sterilized.

FDAApr 30, 2003Nationwide• Medegen Medical Products, LLC

GE Medical Systems Information Technologies: Power cord manufactured by ElectriCord Manufacturing Comp...

Reports of broken plug ground pins on AC power cords for patient monitors.

FDAApr 30, 2003Nationwide• GE Medical Systems Information Technologies

Aspen Surgical Products, Inc.: Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Ea...

Sterility compromised - incomplete sterile package seal.

FDAApr 30, 2003Nationwide• Aspen Surgical Products, Inc.

Cryolife Inc: CryoValve Allograft, Heart valve

Microorganisms were detected in associated allografts.

FDAApr 30, 2003CA, IL, IN +3 more• Cryolife Inc

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