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Contaminated Baxter Heparin Products
Our law firm is investigating several cases involving heparin. 19 people may have died and over 700 other people may have been seriously injured by Baxter's heparin products. Prompted by adverse reactions suffered by patients given Baxter heparin products, the company initiated a recall. Baxter's heparin recall initially involved 14 lots of heparin products. The heparin recall was expanded on February 28 to include all of Baxter Healthcare's multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions. read about the Baxter heparin recall and a Baxter heparin lawsuit.

The information below involves an AM2 Pat heparin recall due to contamination with Serratia marcescens. There has also been a Baxter heparin recall due to contamination with a heparin-like chemical. If you have been injured in any way by a heparin product or if a loved one has died after being administered heparin, please read about the Baxter heparin recall and a possible Baxter heparin lawsuit (discussed in the box above).

* The Heparin recall below has been expanded to include all lots of Heparin pre-filled flush solutions and normal saline flush solutions manufactured by AM2 PAT. Read about the expanded Heparin recall and saline flush recall. *

FDA News Release: AM2 PAT, Inc. Issues Nationwide Recall of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes)

Serratia MarcescensDecember 20, 2007 -- AM2 PAT, Inc., a North Carolina firm, 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. Read about Heparin and Serratia marcescens.

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 Heparin 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.

This product was distributed nationwide including the following states: Florida, Texas, Illinois, Colorado, and Pennsylvania.

It appears from an ongoing Food and Drug Administration (FDA) inspection of AM2 PAT, Inc.’s facility that the firm is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes. The firm is continuing to work with FDA and CDC on monitoring this situation and FDA will provide continuing updates.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Image of Serratia marcescens courtesy of Lee Baines Photography.


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