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Showing 65861–65880 of 68218 results

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Boston Scientific Corporation: Banana Peel Sheaths BP/9/45 Catalog Number : 20-618

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Stryker Instruments Div. of Stryker Corporation: Stryker brand Intra-Compartmental (STIC) Pressure Monitor...

The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.

FDAJul 22, 2005Nationwide• Stryker Instruments Div. of Stryker Corporation

Boston Scientific Corporation: Banana Peel Sheaths BP/11/15 Catalog Number: 20-607

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Vaxcel Chronic Dialysis Catheter - Catheter/PU/14/23/Plas...

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Banana Peel Sheaths - 14/30 Catalog Number: 260203

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/...

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Banana Peel Sheaths - 12/30 Catalog Number: 260202

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Banana Peel Sheaths BP/9/15 Catalog Number: 20-606

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Banana Peel Sheaths BP/12/15 Catalog Number: 20-608

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Tunneled Central Venous Catheters With PASV Valve Technol...

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Banana Peel Sheaths BP/12/30 Catalog Number : 20-614

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Haemonetics Corporation: cardioPAT Cardiovascular Perioperative Autotransfusion Sy...

Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System

FDAJul 22, 2005CA, MN, NE +1 more• Haemonetics Corporation

Boston Scientific Corporation: Banana Peel Sheaths BP/14/30 Catalog Number : 20-615

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Bard Peripheral Vascular Inc: Bard Luminexx 3 Biliary Stent and Delivery System

Angiomed Material Review Board reviewing the manufacturing process observed an increase in the internal scrap rate (failure mode: broken stent struts) of nitinol stents and determined the root cause to be a manufacturing change from polymer to aluminum fixtures.

FDAJul 21, 2005Nationwide• Bard Peripheral Vascular Inc

Baxter Healthcare Corp. Rt.: Baxter Colleague Single Channel Volumetric Infusion Pumps...

A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes.

FDAJul 20, 2005Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Colleague Triple Channel Volumetric Infusion Pumps...

A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes.

FDAJul 20, 2005Nationwide• Baxter Healthcare Corp. Rt.

Spacelabs Medical Incorporated: Ultraview SL Capnography Module, Model 91517 A mainstream...

The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate for pressure changes and CO2 readings will be inaccurate at higher altitudes.

FDAJul 20, 2005IN, WY• Spacelabs Medical Incorporated

ela Medical Llc: Alto VR (model 615) and Alto 2 VR(model 625) Implantable ...

Devices manufactured prior to August 2004 may experience premature battery depletion and/or extended charge times which may affect the device's ability to function.

FDAJul 19, 2005Nationwide• ela Medical Llc

ela Medical Llc: Alto DR (model 614) and Alto 2 DR (model 624) Implantable...

Devices manufactured prior to August 2004 may experience premature battery depletion and/or extended charge times which may affect the device's ability to function.

FDAJul 19, 2005Nationwide• ela Medical Llc

Ortho-Clinical Diagnostics: VITROS Chemistry GENT Reagent REF 680 1711, *** Responsib...

Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.

FDAJul 19, 2005Nationwide• Ortho-Clinical Diagnostics

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