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U.S. Department of Health and Human Services

Medical Devices

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Pre-loaded syringes manufactured by IV Flush, LLC and distributed by Pinnacle Medical Supply should NOT be used because of possible contamination

FDA has issued two nationwide alerts that warn against the use of preloaded syringes manufactured by IV Flush, LLC. These preloaded syringes contain either heparin or sodium chloride intravenous (IV) catheter flushes and may have caused P. fluorescens infections in several patients. These preloaded syringes have not been approved by FDA and should not be used.

Heparin and sodium chloride flushes are routinely used by people who have IV catheters.

  • A sodium chloride catheter flush is used to keep IV catheters from becoming blocked and to remove any medicine from the IV catheter site.
  • A heparin flush is an anticoagulant ('blood thinner') used to prevent the formation of clots that could block the IV catheter.

The preloaded syringes are manufactured by IV Flush, LLC and distributed by Pinnacle Medical Supply, of Rowlett, Texas. Health care facilities and consumers should stop using these products immediately.

For more information please see the February 4th press release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108408.htm