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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-03
January 31, 2005

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA


 

FDA Issues Nationwide Alert on IV Flush Brand of Preloaded Syringes Containing Heparin or Sodium Chloride Intravenous Catheter Flushes

FDA is issuing a nationwide alert against the use of all lots of preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by the IV Flush, LLC and distributed by Pinnacle Medical Supply, of Rowlett, Texas, because these products have not received proper clearance from FDA and may be contaminated.

Consumers and institutions who have these preloaded syringes containing heparin or sodium chloride intravenous flushes should return them to the IV Flush, LLC or the original distributor.

The firm voluntarily recalled the products because they lacked proper FDA clearance for marketing. FDA and the company have also been informed of P seudomonas  fluorescens (P. fluorescens) infections in patients possibly caused by the heparin flushes . These cases are continuing to be investigated.

The heparin and sodium chloride containing intravenous flushes were sold to distributors who redistributed to other medical distributors and hospitals. They can be identified by the syringe label, which reads in part: "IV Flush Dallas, TX."

IV Flush, LLC, is notifying its distributors by phone and letter and has requested those distributors contact their customers. The company is arranging for return of all recalled products.

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.

Consumers with questions may contact the company at 1-972-463-7389. Persons wanting to report anything to the Food and Drug Administration regarding either of these products may contact FDA's MedWatch office at 1 800-FDA-1088.

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