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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
January 26, 2005
IV Flush brand of heparin or sodium chloride intravenous catheter flushes.
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:
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.