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Showing 89121–89140 of 92420 results

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Strategy Pressure Washer (Mei Hao) – Electrical Risk (2003)

These blue and gray electric pressure washers are labeled "Strategy 1500 PSI Powerwasher" and were sold as QVC item number V16257.

CPSCDec 10, 2003Nationwide• Shanghai Mei Hao Electric Appliance Co. Ltd., Shanghai, China

Specialized Mountain Bikes – Brake Rotor Issue (2003)

These are 2004 S Works Enduro and 2004 Enduro Expert mountain bikes with 8-inch brake rotors in the front.

CPSCDec 10, 2003Nationwide• Specialized Bicycle Components Inc., Morgan Hill, Calif.

Diamedix Corporation: Product is packaged in a box and is labeled: Syphilis TRE...

The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.

FDADec 9, 2003AZ, CA, IN +1 more• Diamedix Corporation

Remel, Inc.: ProSpecT Giardia/Cryptosporidium Microplate Assay. Catal...

The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.

FDADec 9, 2003Nationwide• Remel, Inc.

Infinity and Lifestyle Spas (MAAX) – Motor Capacitor Risk (2003)

The recall involves Infinity and Lifestyle model spas manufactured by MAAX Spas. Only MAAX Spas equipped with a Motor Capacitor Inc. capacitor are included in this recall. Units that contain the capacitor have a label on the motor that reads, "Tiny Might." Various models of the spas are included in the recall. Contact the MAAX Spa Fulfillment Center to determine if your model is included in the recall.

CPSCDec 9, 2003Nationwide• MAAX Spas, of Beamsville, Ontario, Canada

Mica Tree Candleholders (Cape Craftsman) – Design Flaw (2003)

The recalled copper and mica candleholders were sold in rectangular and square shapes. The 8.5-inch tall, square-shaped candleholder has a cut-out of an evergreen tree on each side. The 10-inch tall, rectangular-shaped candleholder has cut-outs of an evergreen tree, a star and moon on each side.

CPSCDec 9, 2003Nationwide• Cape Craftsman, of Wilmington, N.C.

General Electric Med Systems: Performix X-ray Tube - Performix ADV, Performix Ultra, So...

Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.

FDADec 8, 2003Nationwide• General Electric Med Systems

Danatech Medical Systems Inc: Product is a handheld fetal Doppler used to screen for fe...

This prescription device, without an approved 510K , was distributed to unauthorized consumers, mostly pregnant women, on the internet.

FDADec 5, 2003Nationwide• Danatech Medical Systems Inc

Baxter Healthcare Corp. Rt: Baxter HomeChoice Automated PD Set with Lineo Connector, ...

Reports of loosening of the connections and disconnection of the device.

FDADec 5, 2003Nationwide• Baxter Healthcare Corp. Rt

Abbott Laboratories HPD/ADD/GPRD: TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories...

The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table

FDADec 5, 2003Nationwide• Abbott Laboratories HPD/ADD/GPRD

Baxter Healthcare Corp. Rt: Baxter Lineo Opticap Disconnect Cap, product codes R5C459...

Reports of loosening of the connections and disconnection of the device.

FDADec 5, 2003Nationwide• Baxter Healthcare Corp. Rt

Abbott Laboratories HPD/ADD/GPRD: TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories,...

The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. % Recovery incorrect.

FDADec 5, 2003Nationwide• Abbott Laboratories HPD/ADD/GPRD

Abbott Laboratories HPD/ADD/GPRD: TDx/TDxFLx Methadone, list 9676-60; Abbott Laboratories, ...

The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table

FDADec 5, 2003Nationwide• Abbott Laboratories HPD/ADD/GPRD

Gyrus Medical, Inc: Gyrus PlasmaKinetic Super Pulse Generator is a micro-comp...

The generator may malfunction when used in close proximity to a monopolar generator.

FDADec 5, 2003Nationwide• Gyrus Medical, Inc

Abbott Laboratories HPD/ADD/GPRD: TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-6...

The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table

FDADec 5, 2003Nationwide• Abbott Laboratories HPD/ADD/GPRD

Nihon Kohden America Inc: AG-920RA Multi-gas unit analyzer

Manufacturing error results in screw affecting electromagnetic interferences. Also metal lid is not tight enough.

FDADec 5, 2003CA, NV, OK• Nihon Kohden America Inc

Fisher & Paykel Healthcare Inc: Phototherapy Lamp, Model 9001W501JE

Laceration Risk

Component placement presents risk of electrocution to patients.

FDADec 5, 2003Nationwide• Fisher & Paykel Healthcare Inc

Abbott Laboratories HPD/ADD/GPRD: ADx Methadone, list 9676-55; Abbott Laboratories, Diagnos...

The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table

FDADec 5, 2003Nationwide• Abbott Laboratories HPD/ADD/GPRD

Snow Play Candleholder (Home Interiors) – Safety Concern (2003)

The recalled candleholder is about 6 inches high and is packaged in a box with "Home Interiors" written on the top of the box. Each candleholder has three snowmen linked by a small rope, "sledding" down a hill around the votive candleholder. The snowmen are painted red, blue, and green.

CPSCDec 4, 2003Nationwide• Home Interiors and Gifts, Inc. of Carrollton, Texas

Polymedco, Inc: POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU...

Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications.

FDADec 3, 2003Nationwide• Polymedco, Inc

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