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Heparin Recall and Saline Flush Recall
Contaminated Heparin

Contaminated Baxter Heparin Products
Our law firm is investigating several cases involving heparin. 81 people may have died and over 700 other people may have been seriously injured by 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 regards a recall of AM2 Pat heparin products. As stated above, there has also been a Baxter heparin recall. Please contact our lawyers if you have been injured by heparin. If you know what heparin product may have been the cause of the injury, please let us know.

Below is the FDA announcement regarding the expanded AM2 Pat heparin recall and saline flush recall due to illnesses caused by Serratia marcescens.

AM2 PAT, Inc. Issues Nationwide Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes

January 18, 2008 - AM2 PAT, Inc., Angier, North Carolina, is initiating a Nationwide recall of all lots of both Heparin and Normal Saline pre-filled flushes manufactured by AM2 PAT. These products are distributed under two brand names, Sierra Pre-Filled Inc. and B. Braun. These products are sold in 3ml, 5ml sizes for Heparin and 3ml, 5ml and 10ml sizes for Normal Saline. Both products are sold as pre-filled 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. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product. [The original recall involved only one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. Read about the original Heparin flush recall.]

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 pre-filled 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.

The following information for this recall includes:

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

PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, All Strengths and Sizes:

LOT # NDC # CATALOG # Product Brand Name
All 64054-1003-02 1003-02 Heparin Lock Flush 100units/ml 5ml
  64054-1003-01 1003-01 Heparin Lock Flush 100units/ml 3ml
  64054-3005-02 3005-02 Heparin Lock Flush 10units/ml 5ml
  64054-3003-02 3003-02 Heparin Lock Flush 10units/ml 3ml
  64054-3003-06 3003-06 Heparin Lock Flush 10units/mL 3ml (6ml syringe)
  64054-3005-06 3005-06 Heparin Lock Flush 10units/mL 5ml (6ml syringe)
  64054-0910-2 0910-12 Normal Saline Flush 10ml
  64054-0905-2 0905-12 Normal Saline Flush 5ml
  64054-0903-2 0903-12 Normal Saline Flush 3ml

The firm voluntarily recalled these products after confirming bacterial contamination in some end user samples of product code 1003-02, Lot 070926H.

These products have been distributed nationwide.

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.

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, 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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