AM2 PAT, Inc. has issued a nationwide recall of Sierra Pre-filled, or B. Braun Heparin syringes. The Heparin syringe has been found contaminated with Serratia marcescens, which can cause life-threatening side effects or death.
What’s the problem?
AM2 PAT, Inc., in association with the U.S. Food & Drug Administration (FDA) has issued two separate product recalls related to the Sierra Pre-filled, or B. Braun Heparin syringe.
On January 25, 2008, the FDA 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 were found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.
On December 20, 2007, AM2 PAT, Inc. initiated a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. The heparin IV flush syringes were found to be contaminated with Serratia marcescens, which have resulted in patient infections. The U.S. Centers for Disease Control & Prevention (CDC) confirmed growth of Serratia marcescens from several unopened syringes of this product.
FDA Video: Recall of Heparin and Saline Flush Syringes
Below is an excellent video published by the U.S. Food & Drug Administration (FDA), which warns of Serratia marcescens infections among users of Sierra Pre-filled and B. Braun Heparin syringes.
Read the Full Transcript: Recall of Heparin and Saline Flush Syringes
Side Effects Associated With The Sierra Heparin Syringe
There are a number of serious side effects associated with the contaminated Heparin syringes. The use of the syringes could cause Serratia related: