The U.S. Food and Drug Administration (FDA) today announced 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.
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.
Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA.
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