FDA recalls Heparin IV flush syringes that have life threatening bacterium.

Manufacturers of pharmaceutical products and manufacturing devices are placed in a position of trust and respect. As consumers, we assume that they take every precaution to provide quality product and to insure our health and safety. Unfortunately, for whatever reasons, sometimes products are released without proper inspection or testing and we, as the consumers are the ones who get injured.

The FDA has recently issued a nationwide recall of heparin IV flush syringes distributed by Sierra Pre-filled because they were found to be contaminated with a possibly life threatening bacterium called Serratia marcescens. Serratia marcescens has been known to cause conjunctivitis, keratitis, endophthalmitis, tear duct infections, urinary tract infections, upper respiratory tract infections, problems in the gastrointestinal system of children, as well as many other serious complications. These complications caused by the bacterium can be dangerous for most healthy adults, for the patients who rely on the syringes they are likely to be deadly.

The heparin syringes are used to clear out intravenous lines and catheters and are most commonly used for home treatment by patients with Cancer and other ailments. Individuals and healthcare providers who use Sierra Pre-filled should be aware that the known affected lot number is #070926H. Individuals who may have used lot #070926H of the Sierra pre-filled heparin flush should immediately stop using the flush and contact their doctor for a replacement supply. Patients should seek immediate medical attention if they develop a fever or other signs of an infection. Nearly 40 cases have been reported of patients taking ill, with half requiring hospitalization due to the infected syringes. No deaths have been reported.

Sierra Pre-filled is a subsidiary of AM2 PAT, Inc., a company based out of Angier, North Carolina. AM2 PAT Inc.’s facility has been under an ongoing inspection from the FDA. It was found out that the firm was not in compliance with the Quality System regulation and has failed to have adequate controls to ensure necessary sterility in its pre-filled syringes. AM2 PAT Inc. is continuing to work with FDA and CDC on monitoring this situation and FDA will provide continuing updates.

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