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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-04
February 4, 2005

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


 

FDA Renews Nationwide Alert on IV Flush Brand of Heparin or Sodium Chloride Intravenous Catheter Flushes in Light of New Contamination Reports

FDA is reissuing 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 new cases of infections that may associated with the use of these unapproved and possibly contaminated products have been reported.

On January 31, 2005 FDA warned consumers and institutions who have these preloaded syringes containing heparin or sodium chloride intravenous flushes to NOT USE THEM and immediately return them to the IV Flush, LLC or the original distributor.

Since that initial warning FDA has been informed of a cluster of Pseudomonas  fluorescens (P. fluorescens) infections in patients that may be associated with 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. Some of the intravenous flushes may have been provided to patients for home use. 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. Clinicians with patients possibly infected from these products should report cases to their state or local health department and the FDA.

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