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FDA > CDRH > Medical Device Recalls > Class I Recall - IV Flush Heparin and Saline IV Catheter Flushes

Medical Device Recalls
Class I Recall: IV Flush Heparin and Saline IV Catheter Flushes

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 the FDA press releases at: http://www.fda.gov /bbs/topics/news/2005/New01154.html.

Updated February 25, 2005

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