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Showing 18781–18800 of 22584 results

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Lumiport, LLC: DermaStyle Chroma 2-blue and red light device indicated t...

Incorrect charger; batteries may overheat , catch fire or explode while being charged with the charger enclosed with the device.

FDASep 28, 2006OR• Lumiport, LLC

Cardinal Health: Convertors Cardiovascular Split Pack II, the pack contain...

The cardiovascular drape may tear and fray at the reinforced fenestrated trough area during use.

FDASep 27, 2006Nationwide• Cardinal Health

Ortho-Clinical Diagnostics: VITROS Chemistry Products GLU DT Slides GEN 56, REF (Cata...

Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56.

FDASep 27, 2006Nationwide• Ortho-Clinical Diagnostics

Teleflex Medical: Sheridan T.T.X. Tracheal Tube Exchanger, Large Size for t...

Biological indicator failed. Investigation eliminated all equipment and product related factors.

FDASep 27, 2006Nationwide• Teleflex Medical

Boston Scientific Corp: Vaxcel Implantable Vascular Access System - Titanium Mini...

Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised.

FDASep 27, 2006Nationwide• Boston Scientific Corp

Invacare Corporation: AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected M...

The incorrect caution label that describes washing instructions was applied to beds distributed in the US, i.e. the specified label is P/N 1116654 (English translation); the label that was used is P/N 1119165 (French translation).

FDASep 27, 2006Nationwide• Invacare Corporation

Teleflex Medical: Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a ...

Biological indicator failed. Investigation eliminated all equipment and product related factors.

FDASep 27, 2006Nationwide• Teleflex Medical

Teleflex Medical: Sheridan Preformed Uncuffed Oral Tracheal Tube, 3.0 mm; a...

Biological indicator failed. Investigation eliminated all equipment and product related factors.

FDASep 27, 2006Nationwide• Teleflex Medical

Cardinal Health: Convertors Tiburon Cardiovascular Split Drape II, Sterile...

The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.

FDASep 27, 2006Nationwide• Cardinal Health

Cardinal Health: Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 unit...

The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.

FDASep 27, 2006Nationwide• Cardinal Health

Cardinal Health: Cardinal Health Sterile Presource PBDS Modules, have Pres...

The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.

FDASep 27, 2006Nationwide• Cardinal Health

Teleflex Medical: Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a R...

Biological indicator failed. Investigation eliminated all equipment and product related factors.

FDASep 27, 2006Nationwide• Teleflex Medical

Smiths Medical MD, Inc.: Locator-Wand Cover that is sold in a shelf carton (unit p...

Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are supplied on the outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an insufficient seal and product sterility could be compromised.

FDASep 27, 2006CA, FL, MD +4 more• Smiths Medical MD, Inc.

Dade Behring, Inc.: Dade Behring brand MicroScan Prompt Inoculation System-D;...

Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.

FDASep 27, 2006Nationwide• Dade Behring, Inc.

Teleflex Medical: Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37...

Biological indicator failed. Investigation eliminated all equipment and product related factors.

FDASep 27, 2006Nationwide• Teleflex Medical

Cardinal Health: Presource Custom Sterile Packs containing the Cardiovascu...

The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.

FDASep 27, 2006Nationwide• Cardinal Health

ICU Medical, Inc.: Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tu...

The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.

FDASep 26, 2006CA, GA, OH +2 more• ICU Medical, Inc.

Abbott Laboratories Inc.: Phenobarbital- Reagent-Clinical Chemistry--List number: 1...

Erratic elevated results and or the inability to calibrate due to imprecision.

FDASep 26, 2006Nationwide• Abbott Laboratories Inc.

Belcher Pharmaceuticals Inc.: Product is Mucotrol Concentrated Oral Gel Wafer contained...

Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.

FDASep 25, 2006Nationwide• Belcher Pharmaceuticals Inc.

Abbott Point Of Care Inc.: i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeto...

Certain lots of G3+ cartridges may be difficult to fill.

FDASep 25, 2006Nationwide• Abbott Point Of Care Inc.

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