The U.S. Food and Drug Administration (FDA) announced a nationwide drug recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc. under the brand name(s) Sierra Pre-filled, Inc. and B. Braun.
The recall was announced after samples tested positive for Serratia marcescens, a bacterium that can cause death and serious injury. Serratia marcescens has been linked to blood infections, urinary tract and wound infections and pneumonia.
The FDA advises all consumers and health care facilities to stop using the recalled products immediately. Consumers should return the products to the location in which they were purchased. Health care facilities should return the recalled products to their distributor.
The recall affects all lots of these products. The FDA received information that 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 has confirmed growth of Serratia marcescens from unopened heparin syringes.