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Medical Advisory 404
 

FDA Issues Nationwide Alert for Preloaded Syringes

The Food and Drug Administration has issued a nationwide alert against the use of all lots of preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by IV Flush, LLC because new cases of infection associated with use of these possibly contaminated products have been reported.

FDA announced that IV Flush had initiated a voluntary recall of the syringes on January 31, 2005 when FDA determined that the syringes lacked proper FDA clearance for marketing. FDA had been informed of a cluster of Pseudomonas fluorescens (P. fluorescens) infections in patients associated with heparin flushes. New reports of infections have led to this second notice. FDA is continuing to investigate the matter.

The syringes are distributed by Pinnacle Medical Supply and can be identified by the marking “IV Flush, Dallas, Texas.” IV Flush is arranging for the return of all recalled products and is in the process of notifying medical distributors and hospitals. Some of the intravenous flushes may have been provided to patients for home use.

The Centers for Disease Control and Prevention reported to the Medical and Scientific Advisory Council of the National Hemophilia Foundation that as of January 2005, no increase in intravenous catheter infections has been reported among individuals with hemophilia (MASAC, February 12, 2005). Nonetheless, the National Hemophilia Foundation urges persons with bleeding disorders in possession of IV flush syringes to inspect the syringes for the “IV Flush, Dallas, Texas” markings. If you have any of these syringes, discontinue use and contact your physician or hemophilia treatment center immediately. FDA has instructed clinicians with patients possibly infected from these products to report cases to their state or local health department, and the FDA. Additionally, anyone with questions can contact IV Flush directly at 1-972-463-7389 or the FDA's MedWatch office at 1 800-FDA-1088.

The February 4, 2005 FDA press release is available at: http://www.fda.gov/bbs/topics/news/2005/NEW01154.html

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.

CHAPTERS: Please distribute this information to your membership.

Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The System is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge.

To enroll in the PNS, please call (888) UPDATE-U or go online at http://www.patientnotification.org.