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FDA PRESS RELEASE: ANGIER, NC -- December 20, 2007 --- AM2 PAT, Inc., Angier, North Carolina, is initiating 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. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product.

This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Consumers and user facilities who have these recalled pre-filled syringes, Heparin Lock Flush Solution USP, should stop using the product immediately. Please quarantine the affected product in your inventory and return it to your distributor immediately.

The following information for this recall includes:

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, North Carolina

PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, 100 units/ml, 5ml in pre-filled syringes.

LOT# NDC# CATALOG #
070926H 64054-1003-02 1003-02

The firm voluntarily recalled this product after confirming bacterial contamination in some end user samples.

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