FDA Announces National Recall of AM2 PAT, Inc. Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes)

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Subject:

FDA Announces National Recall of AM2 PAT, Inc. Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes)

Category:

Food and Drug Administration (FDA)

Published:

Fri, 21 Dec 2007 - 01:00 pm

The FDA and AM2 PAT, Inc., of Angier, North Carolina, have announced the initiation of 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 have been found to be contaminated with Serratia marcescens, which have resulted in patient infections. The Centers for Disease Control and Prevention (CDC) has confirmed growth of Serratia marcescens from several unopened syringes of this product.This type of...

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