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Showing 21481–21500 of 22584 results

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Unknown Manufacturer: 3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right,...

Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE

FDAMay 10, 2004CA, FL, IN +5 more

Unknown Manufacturer: Foundation Knee System, Tibia-Nonporous, Size 6, Right, s...

Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE

FDAMay 10, 2004CA, FL, IN +5 more

Accumetrics Inc: VerifyNow Asprin Assay Kit Part No. 85034

Test results too low in control.

FDAMay 10, 2004Nationwide• Accumetrics Inc

Nipro Diabetes Systems, Inc.: Amigo Insulin Infusion Pump

A FDA inspection of the firm revealed deficiencies in the company's quality system. Problems exhibited may include motor failure or unintended operation.

FDAMay 7, 2004CO, FL, IN +4 more• Nipro Diabetes Systems, Inc.

Hitachi Medical Systems America Inc: Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagn...

Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in mis-diagnosis and delay in treatment.

FDAMay 7, 2004IN, OH, PA +1 more• Hitachi Medical Systems America Inc

Spacelabs Medical Inc.: Ultraview 1700 Monitor Model 90387.

Potential for telemetry channels to drop off display.

FDAMay 7, 2004Nationwide• Spacelabs Medical Inc.

Spacelabs Medical Inc.: Ultraview Universal Clinical Workstation Model 90385.

Potential for telemetry channels to drop off display.

FDAMay 7, 2004Nationwide• Spacelabs Medical Inc.

Cryolife Inc: Alt Pulmonary Valve & Conduit

CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.

FDAMay 6, 2004Nationwide• Cryolife Inc

Cryolife Inc: Alt. Aortic Valve & Conduit

CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.

FDAMay 6, 2004Nationwide• Cryolife Inc

Cryolife Inc: CryoValve, Pulmonary Valve & Conduit

CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.

FDAMay 6, 2004Nationwide• Cryolife Inc

Cryolife Inc: CryoValve, Pulmonary Valve and Conduit - SG

CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.

FDAMay 6, 2004Nationwide• Cryolife Inc

Cryolife Inc: CryoValve, Aortic Valve & Conduit

CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.

FDAMay 6, 2004Nationwide• Cryolife Inc

Cryolife Inc: CryoValve, Pulmonary Valve

CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.

FDAMay 6, 2004Nationwide• Cryolife Inc

Cryolife Inc: CryoValve, Pulmonary Valve & Conduit

During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.

FDAMay 6, 2004FL, NE, NV +6 more• Cryolife Inc

Cryolife Inc: CryoValve, Aortic Valve

CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.

FDAMay 6, 2004Nationwide• Cryolife Inc

Cryolife Inc: CryoValve, Aortic Valve &Conduit

During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.

FDAMay 6, 2004FL, NE, NV +6 more• Cryolife Inc

Toshiba American Med Sys Inc: Magnetic Resonance Imaging System Core Software, Sof...

Software anomaly.

FDAMay 6, 2004Nationwide• Toshiba American Med Sys Inc

Beckman Coulter Inc: Customized Automation Centrifuge, First and Second Genera...

Centrifuge loss of containment with potential for injury or exposure to biohazard among lab workers.

FDAMay 6, 2004Nationwide• Beckman Coulter Inc

United States Surgical: Auto SutureTA 30 Reloadable Stapler,Single Patient Use,3...

Stapler may clamp without the staples being fired into the tissue

FDAMay 5, 2004Nationwide• United States Surgical

United States Surgical: Auto SutureTA 90 Reloadable Stapler,Single Patient Use, ...

Stapler may clamp without the staples being fired into the tissue

FDAMay 5, 2004Nationwide• United States Surgical

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