Contaminant and AM2PAT pre-filled syringes

Baxter was not the only manufacturer to voluntarily recall heparin products.  As early as December of last year, AM2PAT began withdrawing pre-filled heparin and saline syringes after reports of blood infection related reactions to syringe use surfaced.  Incredibly, the contamination found in this lot of heparin was completely different and seemingly independent of the contamination found in the heparin produced by Baxter.  By pure coincidence, it seems, both heparin products were independently contaminated at the same time.

The AM2PAT pre-filled syringes were contaminated with Serratia marcescens bacteria.  This bacterium is very dangerous since contact with it can lead to Serratia marcescens blood infection and death. The pre-filled syringes were manufactured by AM2PAT at their North Carolina facility and distributed under three product labels: AM2PAT, Sierra Pre-Filled, Inc. (AM2PAT’s private label), and B.Braun.

On December 20, 2007, AM2PAT voluntarily launched a nationwide recall of the contaminated heparin pre-filled syringe lot. In a press release issued by the FDA, the agency noted that AM2PAT was “not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.”

A month later, on January 18, 2008, the recall was expanded to include all lots of heparin and saline pre-filled syringes manufactured by AM2PAT.  The FDA issued another press release regarding the expanded recall stating that a second lot had also been contaminated by the harmful bacteria.

Return to Main Article