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AM2 PAT Inc.

FDA Compliance

Nationwide Recall of Prefilled Heparin and Normal Saline Flushes

Published: Tuesday, February 26, 2008 - 23:00

(AM2 PAT Inc.: Angier, North Carolina) -- A nationwide recall of Heparin and Saline prefilled flushes manufactured by AM2 PAT was issued by AM2 PAT. These products are distributed under two brand names, Sierra Pre-Filled Inc. and B. Braun. These products are sold in 3-ml and 5-ml sizes for Heparin and 3-ml, 5-ml, and 10-ml sizes for Normal Saline. Both products are sold as prefilled syringes. The firm voluntarily recalled these products after confirming bacterial contamination in some end-user samples.

It appears from an ongoing Food and Drug Administration inspection of AM2 PAT Inc.’s facility that the firm isn’t in compliance with the quality system regulation and failed to have adequate controls to ensure necessary sterility of its prefilled syringes.

One lot under recall of this product,1003-02, Lot 070926H, Heparin IV flush syringes has been found to be contaminated with Serratia marcescens, which has resulted in patient infections. The Center for Disease Control 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 any of these recalled prefilled syringes, Heparin or Saline Lock Flush Solution USP, should stop using the product immediately. These products should be immediately quarantined in your inventory and returned to your distributor immediately.

For more information, visit www.fda.gov/oc/po/firmrecalls/am2pat01_08.html.

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AM2 PAT Inc.