Posted on 02/04/2005 7:19:59 PM PST by neverdem
By THE ASSOCIATED PRESS
Filed at 8:54 p.m. ET
WASHINGTON (AP) -- The Food and Drug Administration reissued a nationwide alert Friday against the use of IV Flush brand preloaded syringes containing either heparin or sodium chloride because the products have not been approved and may be contaminated.
The FDA first warned consumers and institutions about the syringes on Monday. Since then the agency has been informed of a cluster of infections in patients that may be associated with the heparin flushes. Those cases are still being investigated, said the alert issued Friday.
The syringes, distributed by Pinnacle Medical Supply of Rowlett, Texas, were sold to distributors who redistributed them to hospitals and other medical distributors. The syringe label reads, in part, ``IV Flush Dallas, TX.''
Consumers and institutions who have these syringes should return them to IV Flush or the original distributor, the FDA said. Consumers with questions can contact Pinnacle at 1-972-463-7389.
On the Net:
Food and Drug Administration: http://www.fda.gov
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Me too!!
We've come a long way from Debbie Does.
How does a non-approved product like this make it to the market? I've seen non-approved products used because they were the best tools available (i.e.superglue to help repair cornea damage), but this appears to be a product used solely for the sake of conveniences.
The distributor assumed it had FDA approval, or the manufacturer deceived the distributor. I don't believe there's anything new with the technology.
"The firm voluntarily recalled the products 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 . These cases are continuing to be investigated."
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