The recall on Sierra Pre-Filled syringes, manufactured by AM2PAT, Inc. has been expanded by federal authorities to include the entire U.S. These pre-filled syringes are used by many home treatment patients to flush IV and catheter lines to prevent clotting. Initially, the recall covered only Sierra' pre-filled Heparin syringes after one its lot' was found to be contaminated with a dangerous bacterial infection. On January 18, 2008, the U.S. Food & Drug Administration (FDA) expanded the recall to include all lots and all sizes of both heparin and Saline pre-filled flushes manufactured by AM2PAT. The nationwide recall was announced after an FDA inspection of Sierra Pre-Filled' facility revealed the company "is not in compliance with Quality System regulation." The FDA also found they company "failed to have adequate controls to ensure necessary sterility of its pre-filled syringes."
Contaminated Sierra Syringes Used By 20 Outpatients in Chicago, Illinois
The Centers for Disease Control (CDC) began investigating Sierra Pre-Filled after dozens of blood infections were linked to contaminated pre-filled syringes. About 40 people fell ill in Texas and Illinois, including 20 outpatients at Rush University Medical Center in Chicago. Of the 20 Rush outpatients who became sick, 14 required hospitalization. Doctors at Rush were able to trace the infections to Heparin filled syringes which were being used by home treatment patients with cancer and other illnesses. The recent nationwide recall of AM2PAT syringes are sold under two brand names, Sierra Pre-Filled Inc. and B. Braun.
Medical Dangers Associated With Contaminated Sierra Syringes
Patients with the infection have experienced fever and chills. At this time, one lot under recall of this product 1003-02, Lot 070926H, Heparin IV flush syringes, was confirmed to be contaminated with Serratia marcescens bacteria, resulting in serious blood infections. According to the FDA, "this type of bacteria could present a serious adverse health consequence that could lead to life-threatening injuries and/or death." Antibiotics are the primary form of treatment.
Consumers Of these Recalled Syringes Need to Stop Using the Product
The FDA warns that consumers who have any of these recalled syringes should stop using the product immediately. Any adverse reactions experienced with this product should be reported to the FDA' MedWatch Program at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or on its websit: www.fda.gov/medwatch/.
Consulting A Product Liability Lawyer – Sierra Pre-Filled Syringe Lawsuit
If you or someone you known used these Sierra Pre-Fillled syringes or B. Braun syringes and have become sick, you should contact your doctor immediately to be tested for Serriatia marcescens bacteria. Save the product and its packaging in a secure location, as these materials are important evidence in a potential product liability case. If seeking legal representation, make certain to contact a top persona injury attorney experienced in products liability cases.