Serratia Marcescens Exposure from Heparin Pre-filled Syringes
Serratia Marcescens Contamination
Most recently, Serratia marcescens contamination has been linked to the use of Heparin Pre-filled syringes. The contaminated syringes were manufactured in North Carolina by an Illinois based company known as Sierra Pre-Filled, Inc. and/or AM2 Pat, Inc., and were distributed nationwide in October through December of 2007. There have been many reported cases of Serratia marcescens infection related to the use of these contaminated syringes in numerous states. The largest outbreaks of infection have occurred in Illinois, Texas, and Florida, but the contaminated syringes were distributed nationwide.
FDA Heparin Syringe Recall
On December 20, 2007, Sierra Pre-Filled initiated a nationwide recall of Heparin Lock Flush Syringes, lot #070926H after the Center for Disease Control confirmed Serratia marcescens contamination of samples within the lot. On January 18, 2008, the company expanded the recall to all Heparin and Saline Flush solutions manufactured by Sierra Pre-Filled, Inc., AM2 Pat, Inc., and B. Braun, Inc. The FDA has inspected the North Carolina facility that manufactured the contaminated syringes and has determined that the facility was “not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.” See FDA Recall Notice, December 20, 2007.
Heparin Syringe Use
Heparin Lock Flush syringes are pre-filled with Heparin, a blood thinner that prevents clotting. The syringes are used to flush IV lines (PICC lines, metaports, etc) and are utilized by patients with long-term or permanent IV lines related to an underlying condition. Thus, patients using the contaminated syringes were already in a weakened condition, creating the potential for an opportunistic pathogen such as Serratia marcescens to severely affect them. The FDA has warned that use of the contaminated syringes can pose serious health consequences, including life-threatening conditions and even death.
Contaminated Syringe Lawsuits
If you or a loved one have suffered an injury and contracted the Serratia marcescens bacteria after using Sierra Heparin Lock Flush Solution syringes, then you should contact us immediately to talk to a Board Certified Personal Injury Trial Lawyer, certified by the Texas Board of Legal Specialization. Nationwide Assistance is available and our consultation is free and confidential. Write us online or call us: Toll Free 1-800-883-9858.
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