Heparin Recall – Nationwide Recall Issued on Multiple Products

There have recently been three nationwide recalls issued for different Heparin containing products manufactured by Baxter Healthcare Corporation, AM2 PAT, Inc and B. Braun / Scientific Protein Laboratories LLC.

Warning: Heparin Contaminated with Serratia Marcencens

The pre-filled syringes could be contaminated with bacteria known as Serratia marcencens. Side Effects of Serratia Marcescens include:

• Sepsis
• Infection
• Fever
• Nausea
• Chills
• Vomiting
• Death

Baxter Heparin Recall

Heparin, manufactured by Baxter Healthcare Corporation, has been linked to serious, life-threatening allergic reactions and death.

Heparin has been used in the United States since the 1930s. Baxter recalled nine different lots of their heparin vials on January 17, 2008. As of February 14, 2008, Baxter halted the production of all heparin multi-dose vials.

AM2 PAT Heparin Syringe Recall

Pre-Filled Heparin Lock Flush Solution USP syringes used to flush intravenous and catheter lines to prevent clotting have been recalled due to the recent outbreak of blood infections associated with their use. The pre-filled syringes could be contaminated with bacteria known as Serratia marcencens. There have been close to 50 people in Texas and Illinois who have been affected by these contaminated syringes. On December 20, 2007, AM2 PAT recalled one lot of their pre-filled heparin flush syringes, 070926H. On January 25, 2008, the FDA issued a recall of all lots of heparin and saline pre-filled flush syringes.

B. Braun Heparin Recall

On March 21, 2008, B. Braun began recall the lots of heparin due to a notification received from the supplier, Scientific Protein Laboratories (SPL), disclosing that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient acquired by B. Braun Medical Inc. has a heparin-like contaminant.