The FDA has issued a nationwide recall of heparin IV flush syringes that are contaminated with Serratia marcescens. Serratia marcescens is a possibly life threatening bacteria that has been known to cause conjunctivitis, keratitis, endophthalmitis, tear duct infections, urinary tract infections, upper respiratory tract infections, and problems in the gastrointestinal system of children. The syringes are used to clear out catheters and intravenous lines and are most commonly used by patients for home treatment of Cancer and other ailments. The syringes were distributed by a company called Sierra Pre-filled, a subsidiary of the AM2 PAT, Inc., a company based out of Angier, North Carolina.
Nearly 40 cases have been reported of patients taking ill, with half requiring hospitalization due to the infected syringes. No deaths have been reported. The syringes were distributed to the states of Colorado, Florida, Illinois, Pennsylvania, and Texas.
AM2 PAT Inc.’s facility has been under an ongoing inspection from the FDA. The firm is not in compliance with the Quality System regulation and has failed to have adequate controls to ensure necessary sterility in its pre-filled syringes. The firm is continuing to work with FDA and CDC on monitoring this situation and FDA will provide continuing updates.
If you or someone you know has been injured due to use of infected heparin IV syringes, please contact the law offices of Gordon & Doner. Our attorneys have the experience and expertise to help you prove your case.