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Heparin and Normal Saline Pre-Filled Flushes Recall Due to Bacteria Contamination

Submitted by jrlaw on Mar 9th, 2009

AM2 PAT, Inc. issued a nationwide recall of all lots of both Heparin and Saline pre-filled flushes. These products are distributed under two brand names, Sierra Pre-Filled Inc and B. Braun. The products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was contaminated with Sierratia marcescens which has resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. User facilities and consumers should stop using the product immediately, quarantine remaining inventory, and return the product to their respective distributor.

Read the FDA posting: