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U.S. Department of Health and Human Services

Safety

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IV Flush Brand of Preloaded Syringes Containing Heparin or Sodium Chloride

Audience: Hospital risk managers, pharmacists, nursing administrators, and other healthcare professionals

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 they lacked proper FDA clearance for marketing. FDA and the company have also been informed of Pseudomonas fluorescens (P. fluorescens) infections in patients possibly caused by the heparin flushes.

[UPDATE February 4, 2005 - Press Release - FDA]
[January 31, 2005 - Press Release - FDA]
[February 25, 2005 - Recall Notice - FDA]