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Showing 86981–87000 of 92420 results

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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

Tiki Cone Metal Torch – Fire Safety Risk (2005)

The recalled Tiki® Cone Metal Torch is a 6-foot-long outdoor open-flame lamp consisting of a black metal pole topped by a copper-colored, cone-shaped metal head. A black decorative rod spirals around the head of the torch. The torch head includes the fuel reservoir, cover and wick. It was sold under Lamplight Farms model numbers 1263 and 126301 and Wal-Mart item numbers 1656121 and 1691366. Both items were sold with the same UPC number 086861012635, which is located on the bottom of the printed hangtag.

CPSCJul 19, 2005Nationwide• Lamplight Farms Inc., a Division of W.C. Bradley Company, of Menomonee Falls, Wis.

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

So Hot Way Cool Trucks – Product Defect (2005)

The recall includes four-piece "So Hot Way Cool Free Wheel" Truck sets. Various trucks sold in the sets include a combination of fire trucks, oil trucks, vegetable trucks, sanitation trucks, tow trucks and box trucks. Writing on the trucks includes, "EMERGENCY" or "CITY SERVICE." The words "So Hot Way Cool Free Wheel Truck" and the item number 204 02 0838 are written on the packaging.

CPSCJul 19, 2005Nationwide

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

ela Medical Llc: Alto MSP (model 617) and Alto 2 MSP (model 627) Implantab...

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

Guidant Corporation: PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker....

A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.

FDAJul 18, 2005Nationwide• Guidant Corporation

Guidant Corporation: VIRTUS PLUS II (model nos. 1380 and 1480) pacemaker. St...

A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.

FDAJul 18, 2005Nationwide• Guidant Corporation

Guidant Corporation: CONTAK TR (Model no. 1241) pacemaker. Sterilized with g...

A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.

FDAJul 18, 2005Nationwide• Guidant Corporation

Staar Surgical Co Inc: Staarvisic II Sodium Hyaluronate, 0.8 mL

Sterility may be compromised.

FDAJul 18, 2005Nationwide• Staar Surgical Co Inc

Guidant Corporation: PULSAR and PULSAR MAX (model nos. 470, 870, 970, 972, 117...

A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.

FDAJul 18, 2005Nationwide• Guidant Corporation

Guidant Corporation: MERIDIAN (model nos. 476, 976, 1176 and 1276) pacemaker. ...

A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.

FDAJul 18, 2005Nationwide• Guidant Corporation

Guidant Corporation: DISCOVERY (model nos. 1174, 1175, 1273, 1274 and 1275) pa...

A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.

FDAJul 18, 2005Nationwide• Guidant Corporation

Guidant Corporation: INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485...

A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.

FDAJul 18, 2005Nationwide• Guidant Corporation

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