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Syringe scare leads to FDA alert

Ambulatory Safety Monitor, February 10, 2005

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The Food and Drug Administration (FDA) last week reissued a nationwide alert concerning batches of preloaded syringes that may be contaminated. The alert, which was originally passed on to consumers on January 31, was renewed following the discovery of new cases of infection that may be related to the syringes.

According to a release from the FDA, a number of patients have recently developed pseudomonas fluorescens (or P. fluorescens) infections of the blood, and investigators say the illnesses could be connected to the syringes. P. fluorescens is an infrequent cause of infection, but has been reported to cause outbreaks of pseudobacteremia, i.e., presence in a blood culture in the absence of clinical evidence of bloodstream infection. P. fluorescens has also been reported as the cause of procedure-related infections and infections resulting from transfusion with contaminated blood components.

The syringes in question were manufactured by IV Flush, LLC, and distributed by Pinnacle Medical Supply of Rowlett, TX. The preloaded syringes contained either heparin or sodium chloride intravenous catheter flushes, and were voluntarily recalled by the manufacturer. The products were not cleared by the FDA for marketing at the time of their distribution.
The FDA warns facilities not to use any of these syringes, which clearly designate "IV Flush Dallas, TX" on their labels. IV Flush is also asking all its distributors to call their customers to warn them about the syringes, and the company is arranging for the return of all products recalled.

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