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U.S. Department of Health and Human Services

Medical Devices

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IV Flush Heparin and Saline IV Catheter Flushes

Class I Recall
Date Recall
Initiated:
January 26, 2005
Product:
IV Flush brand of heparin or sodium chloride intravenous catheter flushes.
Use:
These preloaded syringes are used to flush intravenous catheter lines with either heparin or saline solution.
Recalling Firm:
IV Flush, LLC
3905 Melcer Drive, Suite 601
Rowlett, Texas 75088
Reason for Recall:
The devices were marketed without proper FDA clearance and are suspected to be contaminated with Pseudomonas flourescens, a pathogenic bacteria.
Public Contact:
Clinicians, patients or consumers with inquiries should contact the company at 1-972-463-7389.
FDA District:
Dallas
FDA Comment:
Hospitals and consumers should not use these preloaded syringes and should immediately return them to the firm or to the original distributor, Pinnacle Medical Supply.  Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
  For additional information on this product recall, see nearby links.