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Showing 88601–88620 of 92420 results

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Roche Diagnostics Corp.: Disetronic brand 5 ml. glass cartridges used with the Pan...

Lack of assurance of sterility.

FDAMay 17, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Disetronic brand 3.15 ml glass cartridges used with H-tro...

Lack of assurance of sterility.

FDAMay 17, 2004Nationwide• Roche Diagnostics Corp.

Boston Scientific Scimed: Boston Scientific Sentinol Self-Expanding Nitinol Biliary...

One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The product, pouch label and carton label are all correct and the correct DFU is in the package.

FDAMay 14, 2004IN, KY, MA +8 more• Boston Scientific Scimed

Philips Medical Systems Sales & Service Region No. America: Trolley for Intera/NT MRI System

Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley.

FDAMay 13, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

Teleflex Medical, Inc.: Latex Free*** REF B1000P Belly Bag Urine Collection Bag w...

Firm received complaints of leaking urine collection bags.

FDAMay 13, 2004Nationwide• Teleflex Medical, Inc.

Teleflex Medical, Inc.: Latex-Free REF B1000, Belly Bag Urine Collection Bag with...

Firm received complaints of leaking urine collection bags.

FDAMay 13, 2004Nationwide• Teleflex Medical, Inc.

Children's Board Books with Sound Maker (DK Publishing) – Sound Hazard (2004)

Choking Hazard

The heavy cardboard books were sold under eight different titles that feature photos or illustrations of the title theme: Dinosaurs, Emergency! (with a fire truck on the cover), Kitty's Adventure, On The Road (with a yellow Volkswagon Beetle on the cover), Puppy's Busy Day, Tractors, Trains, and Trucks. All the books have a raised sound button in the lower right corner, which features a sound relevant to the title. The "DK" logo is in the lower left corner of the books.

CPSCMay 13, 2004Nationwide• DK Publishing Inc., of New York, N.Y.

Metal Bunk Beds (Coaster Co.) – Structural Risks (2004)

The recall involves model 2008, 2056, 2256 and 2258 bunk beds. The metal bunk beds were sold in twin/twin and twin/full sizes. A Coaster Company of America label can be found on the bed frame of the top bunk. The enamel finishes come in blue, black, red, yellow, or white.

CPSCMay 13, 2004Nationwide• Coaster Co. of America, Santa Fe Springs, Calif.

Passport Stroller (Baby Trend) – Safety Defect (2004)

These Baby Trend strollers have the word "Passport" written on both sides of the canopy. Only "Passport" strollers with Model Number 1514, SKN number 190554 and manufacturing dates between July 10, 2003 and November 26, 2003 are being recalled. This information is printed on the lower frame of "Passport" strollers behind the seat.

CPSCMay 13, 2004Nationwide• Baby Trend, Inc., of Ontario, California

Abbott Laboratories: CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-0...

Incorrect Test Results-test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).

FDAMay 12, 2004AL, CA, CO +27 more• Abbott Laboratories

Vascular Solutions, Inc.: The Pronto Extraction Catheter is indicated for the remov...

The marker band in guidewire lumen could move from the manufactured location during clinical use.

FDAMay 12, 2004Nationwide• Vascular Solutions, Inc.

Abbott Labs: GemStar I.V. Administration Pump Set with Orange Polyethy...

The firm's internal testing that revealed the potential air-in-line may go undetected when the set is used at temperatures above 25C (77 F).

FDAMay 11, 2004Nationwide• Abbott Labs

Medtronic Inc, Neurological & Spinal Division: Synchromed II infusion pump

The opposite version serial numbers were assigned to 20mL and 40mL SynchroMed II Model 8637 pumps. This size-type indication is used by the programmer to identify the pump size and can cause a limitation in the useable fill volume on a 40 mL pump and could cause some confusion related to the size of a 20 mL pump which identifies itself as a 40 mL pump.

FDAMay 11, 2004Nationwide• Medtronic Inc, Neurological & Spinal Division

Universal Electric Outlet Adaptor Plug (E & B Giftware) – Electrical Hazard (2004)

These universal electric outlet adaptor plugs were sold as either the Worldwide or Universal Adaptor Plug under four brand names: Samsonite, Royal Traveller, American Tourister and El Portal. "MODEL: 1804" is written on the bottom of the adaptor plug. They contain three adaptor plugs, which are used by travelers worldwide to connect electrical plugs into electrical sockets. The adaptors include a hard plastic case, which houses the three different plugs. A knob on the top of the product can be turned to extend the plugs for use.

CPSCMay 11, 2004Nationwide• E and B Giftware LLC, of Yonkers, N.Y.

Lodox Na Llc: Lodox Statscan digital radiographic system.

The labels do not have proper identification and certification and the firm failed to provide adequate test and quality control procedures to establish certification by the manufacturer.

FDAMay 10, 2004IL, MD• Lodox Na Llc

Dynarex Corporation: 100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reord...

Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.

FDAMay 10, 2004AZ, CA, CO +21 more• Dynarex Corporation

Unknown Manufacturer: Foundation Knee System, Tibia-Nonporous, Size 6, Right, s...

Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE

FDAMay 10, 2004CA, FL, IN +5 more

Accumetrics Inc: VerifyNow Asprin Assay Kit Part No. 85034

Test results too low in control.

FDAMay 10, 2004Nationwide• Accumetrics Inc

Unknown Manufacturer: 3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right,...

Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE

FDAMay 10, 2004CA, FL, IN +5 more

Spacelabs Medical Inc.: Ultraview Universal Clinical Workstation Model 90385.

Potential for telemetry channels to drop off display.

FDAMay 7, 2004Nationwide• Spacelabs Medical Inc.

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