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FDA Recalls Contaminated Syringes

FDA Recalls Contaminated Syringes

Jan 25, 06:40 PM

The U.S. Food and Drug Administration announced a recall Friday of all heparin and saline pre-filled flush syringes manufactured by AM2 PAT Inc.

Two lots of the syringes have have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death, the agency said in a release.

The syringes, manufactured under the brand names Sierra Pre-filled, Inc. and B. Braun, are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.

The FDA said Heparin Lock Flush syringes from Lot 070926H and Normal Saline IV syringes from Lot 070917A have been found to be contaminated with Serratia marcescens, and have resulted in patient infections. The U.S. Centers for Disease Control and Prevention confirmed growth of Serratia marcescens from unopened heparin syringes, the agency said. FDA Recalls Contaminated Syringes
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