B. Braun Update: 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.
AM2 PAT Heparin Update: Pre-Filled Heparin Lock Flush Solution USP, manufactured by AM2 PAT, Inc., of Angier, N.C, has been linked to serious, life-threatening side effects due to contamination of Serratia marcescens.
These syringes were manufactured by Am2Pat and may be labeled as: Am2Pat, Sierra Pre-filled, or B. Braun. On December 20, 2007, AM2 PAT recalled one lot of their pre-filled heparin flush syringes. On January 25, 2008, the FDA issued a recall of all lots of heparin and saline pre-filled flush syringes.
What is the problem with Heparin?
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.
Side Effects of Heparin Induced Serratia Marcescens Infections
There are a variety of side effects associated with these contaminated syringes. The use of the syringes could cause Serratia related: