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drug_recall heparinHeparin infections became a serious concern following a nationwide recall of heparin syringes in December 2007. The syringes were found to be contaminated with a strain of bacteria called Serratia marcescens. The heparin infections linked to the tainted syringes were life-threatening. According to the January 25, 2008 warning from the U.S. Food and Drug Administration (FDA):
“Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections.”
The syringes were pre-filled with heparin, an anticoagulant that is often used to keep catheters open and free from clogging. The recalled products were labeled “Pre-Filled Heparin Lock Flush Solution USP” with 5 mL (milliliters) of heparin in 12-mL syringes. The syringes can be used in a hospital or at home by a patient to flush a catheter or an intravenous line.
More than 40 severe heparin infections are linked to the use of these syringes, which were made by AM2 PAT, Inc. of Angier, NC. One lot, or about 17,000 units, was recalled, and the U.S. Centers for Disease Control and Prevention (CDC) later confirmed that Serratia marcescens was present in syringes from this lot. A second contaminated lot was also identified.
The recall now includes all strengths and sizes of Heparin or Saline Lock Flush Solution USP distributed under the names Sierra Pre-Filled Inc. and B. Braun.
The heparin infection associated with Serratia marcescens can cause severe infection or even death. The symptoms of heparin infection include:
There is an ongoing investigation of the link between the Sierra/B. Braun syringes and the heparin infections. An FDA report notes that the manufacturing facility where the syringes were made is not in compliance with their Quality System regulation, and that efforts to maintain sterile conditions were not adequate.
If you have suffered from a heparin infection, contact a defective products attorney today to learn more about recovering money for your losses.
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