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Showing 87841–87860 of 92420 results

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Ethicon Endo-Surgery: Endopath EZ45 No Knife Linear Stapler (NK45B).

The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.

FDANov 21, 2004Nationwide• Ethicon Endo-Surgery

Ethicon Endo-Surgery: Endopath EZ45 Endoscopic Linear Cutter (EZ45B)

The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.

FDANov 21, 2004Nationwide• Ethicon Endo-Surgery

Edwards Lifesciences Research Medical Inc: EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.

Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.

FDANov 19, 2004AL, CA, CO +21 more• Edwards Lifesciences Research Medical Inc

Baxter Healthcare Corp. Rt.: Baxter labeled 6060 Solution Sets with AutoClamp; For use...

A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient.

FDANov 19, 2004Nationwide• Baxter Healthcare Corp. Rt.

Roche Diagnostics Corp.: ACCU-CHEK Inform meter; catalog No. 3035123.

A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.

FDANov 19, 2004Nationwide• Roche Diagnostics Corp.

3.7-inch Stator (Emerson) – Manufacturing Defect (2004)

The stators were sold to Procon Products for the application in insecticide insertion pumps and water purification systems.

CPSCNov 19, 2004Nationwide• Emerson Motor Co., 8100 W. Florissant Ave., St. Louis MO 63136

Kubota RTV900 Utility Vehicles – Safety Concern (2004)

The RTV900 Utility Vehicles are four-wheel, off-road vehicles with cargo boxes. They are designed for two people to sit side by side. "RTV900" appears on the side of the front hood. The serial number range for the affected vehicles is 10001 through 25883.

CPSCNov 19, 2004Nationwide

TriLite Stool (Byer) – Stability Issue (2004)

This recall includes Byer of Maine TriLite Stools shipped between February 19, 2004 and June 16, 2004. The affected stools are only those that have been produced in China, specifically those that bear the Byer of Maine logo screen printed in silver ink on the plastic leg hub.

CPSCNov 19, 2004Nationwide• The Byer Manufacturing Company, of Orono, Maine

Meter Socket Load Center (Midwest) – Electrical Risk (2004)

The following models are included in this recall: model numbers R256EB1A, R256EB1NA, and R256EB1018A (Midwest) and TSLR1220CSAL (GE). Affected date code range is SAL421 through 432.

CPSCNov 19, 2004Nationwide• Midwest Electric Products, HW 22 North, Mankato, MN 56001

Pulmonetic Systems, Inc.: Universal Cable Adaptor (Part #17765-001 and labeled on o...

Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.

FDANov 19, 2004Nationwide• Pulmonetic Systems, Inc.

Diagnostic Products Corp: Immulite 2500 insulin Kit

Low bias of 10 to 40% at different levels of insulin in samples.

FDANov 19, 2004AK, IN, NY +1 more• Diagnostic Products Corp

Baxter Healthcare Corp. Rt.: Sabraset Administration Sets with AutoClamp; for use with...

A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient.

FDANov 19, 2004Nationwide• Baxter Healthcare Corp. Rt.

Medtronic Inc, Neurological & Spinal Division: Model 8561 Lioresal (Baclofen injection) Intrathecal Refi...

Outer package of Lioresal Intrethecal Refill Kit, model 8561, identifies the kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration, 500 mcg/ml (10 mg/20 ml). Lot N0016487 incorrectly contains 1-20 ml ampule of baclofen concentration 2000 mcg/ml (40 mg/20 ml).

FDANov 19, 2004Nationwide• Medtronic Inc, Neurological & Spinal Division

Cordis Corporation: Cypher Sirolimus-eluting Coronary Stent on Raptor Over-th...

Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.

FDANov 18, 2004Nationwide• Cordis Corporation

Hitachi Medical Systems America Inc: Altaire, Magnetic Resonance Imaging Device.

The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.

FDANov 18, 2004AL, AZ, AR +34 more• Hitachi Medical Systems America Inc

Ormco Corporation: Titanium Orthos Bracket

Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.

FDANov 18, 2004Nationwide• Ormco Corporation

Okie Dokie Pajama Set – Safety Concern (2004)

The recalled pajama shirts are heather gray with red or blue sleeves with heat-sealed alligator and football patches on the front. The collar tag reads "Okie Dokie." The pajama pants are red or blue with cartoon pictures of alligators, footballs, and stars, and the word "football." They were sold in infant sizes 12M to 24M and toddler sizes 2T to 5T. This recall does not include the pajama sets with the alligator and football silk-screen images on the pajama shirts.

CPSCNov 18, 2004Nationwide

Electric Pictures – Electrical Problem (2004)

The recalled electric pictures are framed artwork that utilize electric lights and sound and feature moving background scenes, including waterfalls, snow, beach scenes, city skylines, and religious figures. Some of the pictures contain battery operated clocks. The paintings come with wooden, glass mirror, or plastic frames. The pictures come in four different sizes: 99cm x 48cm; 65cm x 47cm; 35cm x 35cm; and 33cm x 19cm.

CPSCNov 18, 2004Nationwide

Jenn-Air Downdraft Gas Cooktops (Maytag) – Safety Issue (2004)

The recall includes built-in Jenn-Air model JGD8348CDP downdraft gas cooktops. They have serial numbers xxxxxxxEA through xxxxxxxER. The cooktops were manufactured by Maytag between January 1, 2004 and September 17, 2004. The model name and serial number are printed on a label on the vent fan housing, which is visible in the cabinet under the cooktop.

CPSCNov 17, 2004Nationwide• Maytag Corp., of Newton, Iowa

Neuton Cordless Lawnmowers – Performance Issue (2004)

Laceration Risk

The recalled lawnmowers were sold under the NEUTON name and carry model number 81030. NEUTON is printed on the front portion of the lawnmower. The lawnmowers have a 14-inch cutting width with rear bagging capability.

CPSCNov 17, 2004Nationwide

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