Heparin Risks
January 25, 2008: The Food & Drug Administration (FDA) announce a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc.. 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 pre filled heparin and saline flush syringes made by Am2Pat.
Background:
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 that were given to patients requiring home care for cancer and other treatments. Heparin is a type of blood thinner and 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.
40 cases of blood infections have been reported in Illinois and Texas and syringes from the same tainted batch were also sent to Florida, Colorado and Pennsylvania.
Symptoms of the blood infection may include fever, chills and vomiting and can be treated by antibiotics. However, cancer patients immune systems are already weakened and infections caused by the bacterium Serratia marcescens can be life-threatening.
The FDA recalled the contaminated Sierra Pre-Filled Syringes mid-December and is advising doctors to quarantine the syringes and return to the distributor. 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.
Where can I find additional information?
What can I do?
If you have experienced any adverse effects from your use of Heparin, you should immediately consult your physician. You may also want to consider your potential legal claim. If you would like more information, click here to fill out a free case review form or contact attorney Stacy Hauer directly, toll-free at 800.755.0098. Zimmerman Reed is experienced in handling defective medical device cases and we welcome any questions you may have.
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