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Showing 66421–66440 of 68218 results

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Baxter Healthcare Corp. Rt.: Anesthesia Set, product code 2C9216; a sterile fluid path...

The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component.

FDADec 20, 2004Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Logix-CM Compounder Software, catalog 2M8400; Baxter Heal...

Logix-CM software version 3.0.4 has not completed its official release process.

FDADec 20, 2004AZ, CA, NC +2 more• Baxter Healthcare Corp. Rt.

Cryolife Inc: CryoValve, Aortic Valve & Conduit SG

During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation.

FDADec 17, 2004CA, NJ, TX• Cryolife Inc

Cryolife Inc: CryoValve, Aortic Valve and Conduit

Records noted that the infant donor's mother had tested positive for Hepatitis B.

FDADec 17, 2004CA, FL• Cryolife Inc

Cryolife Inc: CryoValve, Pulmonary Valve and Conduit

During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation.

FDADec 17, 2004CA, NJ, TX• Cryolife Inc

Nellcor Puritan Bennett Inc: Model 740 and 760 series Ventilators.

Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.

FDADec 17, 2004Nationwide• Nellcor Puritan Bennett Inc

Cryolife Inc: CryoValve, Pulmonary Valve & Conduit

Records noted that the infant donor's mother had tested positive for Hepatitis B.

FDADec 17, 2004CA, FL• Cryolife Inc

Zimmer Austin, Inc: MOST Options System Porous and Non-Porous Revision Stem A...

Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.

FDADec 17, 2004AZ, CA, FL +9 more• Zimmer Austin, Inc

Nellcor Puritan Bennett Inc: Internal Battery for Puritan Bennett 700 Series Ventilator.

Wires on battery may loosen causing disconnection.

FDADec 16, 2004Nationwide• Nellcor Puritan Bennett Inc

Beckman Coulter Inc: COULTER LH 750 Hematology Analyzer.

A rare risk of sample misidentification exists with Coulter LH 750 Hematology Analyzers. The printout results from the instrument are affected; however, the results stored in the workstation's database are not affected.

FDADec 16, 2004Nationwide• Beckman Coulter Inc

Ethicon, Inc US: VERSAPOINT, Hysteroscopic system Connector Cable, Non-Ste...

Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes.

FDADec 16, 2004IN• Ethicon, Inc US

Ethicon Endo-Surgery: FlexTrayTM Endopath Gen. Laparoscopy Tray, Kit Code TGL45.

Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.

FDADec 15, 2004Nationwide• Ethicon Endo-Surgery

Ethicon Endo-Surgery: FlexTrayTM Endopath Bariatric Tray, Kit code KBW22

Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.

FDADec 15, 2004Nationwide• Ethicon Endo-Surgery

Ethicon Endo-Surgery: Endopath 10 mm Anvil Graspers with Ratchet Handles (produ...

Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.

FDADec 15, 2004Nationwide• Ethicon Endo-Surgery

Ethicon Endo-Surgery: FlexTrayTM Endopath Gastric Tray, Kit code KDG05.

Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.

FDADec 15, 2004Nationwide• Ethicon Endo-Surgery

Ethicon Endo-Surgery: FlexTrayTM Endopath Appendectomy Tray, Kit code KNB12.

Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.

FDADec 15, 2004Nationwide• Ethicon Endo-Surgery

Philips Medical Systems: Philips Heartstart MRx Monitor/Defibrillator Models: M35...

In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy

FDADec 15, 2004Nationwide• Philips Medical Systems

Ethicon Endo-Surgery: Endopath 5 mm Babcocks with Ratchet Handles (product code...

Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.

FDADec 15, 2004Nationwide• Ethicon Endo-Surgery

Ethicon Endo-Surgery: ENDOPATH 10 mm Babcocks with Ratchet Handles (product cod...

Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.

FDADec 15, 2004Nationwide• Ethicon Endo-Surgery

Ethicon Endo-Surgery: Endopath 5 mm Graspers with Ratchet Handles (product code...

Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.

FDADec 15, 2004Nationwide• Ethicon Endo-Surgery

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