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: Legal Blog

FDA Warns Public of Contaminated Syringes Manufactured by AM2 PAT, Inc. Containing Heparin and Saline Pre-filled Flush Syringes

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The U.S. Food and Drug Administration (FDA) announced on January 25, 2008, a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death, and have in fact caused blood infections in patients. These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.

Full post as published by Legal Blog on February 02, 2008 (boomark / email).

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