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Heparin Injections
| Heparin Injections |
| | 102 | 2008-03-16 |
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| On January 25, 2008, the FDA announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death. The recall applies to all prefilled heparin and saline flush syringes made by Am2Pat Heparin InjectionsBack in December 2007, Federal health officials announced they were investigating dozens of blood infections caused by a bacterium called Serratia marcescens. The bacterium has been traced to medical syringes containing heparin and given to patients requiring home care for cancer and other treatments. Heparin is a type of anticoagulant-- a blood thinner. It is commonly used in the treatment of deep vein thrombosis by keeping existing blood clots from getting bigger or preventing new clots from developing. It is also given to home patients to clear out catheters and intravenous lines. To date about 40 cases of blood infections have been reported in Illinois and Texas; syringes from the same tainted batch were also sent to Florida, Colorado and Pennsylvania. Symptoms of the blood infection include fever and chills and vomiting; antibiotics are the usual course of treatment. However, immune systems of cancer patients are already compromised and infections such as those caused by the bacterium Serratia marcescens can be life-threatening. The Food & Drug Administration (FDA) recalled the contaminated Sierra Pre-Filled Syringes mid-December and is advising doctors to “quarantine” the syringes and return to the distributor. Sierra PreFilled, manufacturer of the syringes, is located in Angier, North Carolina. The FDA stated that the manufacturer is “not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes”. Heparin Injections (contaminated syringes) On January 25, 2008, the FDA announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death. The recall applies to all prefilled heparin and saline flush syringes made by Am2Pat |
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