Class 1 Recall: AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes (All Lots and All Sizes)

December 20, 2007

AM2 PAT Inc. (doing business as Sierra Pre-Filled Inc.), All Lots and All Sizes of Pre-Filled Heparin Lock Flush Syringes and Pre-Filled Normal Saline IV Flush Syringes

These products are distributed under two brand names, Sierra Pre-Filled Inc. and B. Braun.

Pre-Filled Heparin Lock Flush and Pre-Filled Normal Saline IV Flush keep the IV (intravenous) devices functioning properly and keep IV ports open.

Some end-user samples of Pre-Filled Heparin Lock Flush syringes, Product Code 1003-02, Lot 070926H, were found to be contaminated with a bacteria (Serratia marcescens) which resulted in patient bloodstream infections. The Centers for Disease Control and Prevention (CDC) has confirmed growth of Serratia marcescens from one unopened syringe of this product. The CDC has also received reports of Serratia marcescens infections associated with the Pre-Filled Normal Saline IV Flush syringes.

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

On December 20, 2007, AM2 PAT Inc. issued a press release and recall letter to its customers regarding their recall of Pre-Filled Heparin Lock Flush syringes Lot 070926H. The customers were instructed to immediately stop using the product, to quarantine all products in their inventory, and to return them to the distributor. The firm initiated this recall when they were notified by CDC of the Serratia marcescens bloodstream infections and CDC’s testing, which confirmed the presence of the Serratia marcescens in one unopened syringe. On January 16, 2008, the firm expanded the recall to include all lots and all sizes of the Pre-Filled Heparin Lock Flush syringes and the Pre-Filled Normal Saline IV Flush syringes. The recall expansion was due to reports of Serratia marcescens infections associated with the Normal Saline IV Flush syringes, as well .

Consumers and user facilities that have these recalled pre-filled syringes, Heparin Lock or Normal Saline IV Flush, should stop using these products immediately. Facilities should quarantine the affected products in their facilities and return them to their distributor immediately.

For more information about this recall, please see the company’s press release at: http://www.fda.gov/oc/po/firmrecalls/am2pat01_08.html

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online:www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178