RSSArchive for March 17th, 2010

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Abiomed AB5000 Circulatory Support System: Class I Recall

Device computer may shut down without an alarm, which can lead to serious injuries or death.

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WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis

Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.

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Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall

Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.

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Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures

FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.

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Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall

Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell.

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Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug

Boxed warning added regarding reduced effectiveness of Plavix in poor metabolizers.

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Counterfeit Polypropylene Surgical Mesh: Initial Communication

Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name.

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Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall

Product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged.

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Fix a Leak Week Showcases How Americans Can Save Water and Money (CT, ME, MA, NH, RI, VT)

(Boston, Mass.—March 16, 2010) Across the country, household leaks are wasting more than 1 trillion gallons of water per year—enough water to supply every home in Texas with its annual water needs

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MEDIA ALERT: EPA Will Announce the Results of its Evaluation of Spot-on Tick-and-Flea Products for Dogs and Cats (HQ)

FOR IMMEDIATE RELEASE
March 16, 2010 WASHINGTON – EPA will hold a press teleconference to announce its findings in the evaluation of spot-on products for dogs and cats

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EPA Announces the New Office of International and Tribal Affairs Action part of Administrator’s priority to build strong tribal partnerships (HQ)

WASHINGTON – U.S. Environmental Protection Agency Administrator Lisa P