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U.S. Department of Health and Human Services

Safety

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Heparin and Normal Saline Pre-Filled Flushes

Audience: Pharmacists, hospital risk managers, other healthcare professionals, patients

[Posted 01/18/2008; updated 01/30/2008] AM2 PAT, Inc., notified healthcare professionals and patients of a nationwide recall of all lots of both Heparin and Normal 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 Serratia 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. For a complete list of the recalled products, see the Recall Notice.

[January 30, 2008 - Class 1 Recall - FDA]
[January 25, 2008 - News Release - FDA]
[January 18, 2008 - Press Release - AM2 PAT, Inc.]
[January 18, 2008 - Press Release - B. Braun]