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FDA Reissues Alert for Preloaded Syringes
NY Times ^ | February 4, 2005 | NA

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


TOPICS: Business/Economy; Culture/Society; Government; News/Current Events; US: District of Columbia
KEYWORDS: fda; health; healthcare; syringes

1 posted on 02/04/2005 7:20:00 PM PST by neverdem
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To: El Gato; JudyB1938; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; jb6; tiamat; PGalt; ..

FReepmail me if you want on or off my health and science ping list.


2 posted on 02/04/2005 7:22:11 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem
Thanks, neverdem...I've got a relative who has to use syringes with Sodium Chloride...will check immediately!
3 posted on 02/04/2005 7:43:37 PM PST by hummingbird ("If it wasn't for the insomnia, I could have gotten some sleep!")
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To: neverdem

Me too!!


4 posted on 02/04/2005 8:34:31 PM PST by pitinkie (revenge will be sweet)
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To: neverdem
`IV Flush Dallas

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.

5 posted on 02/04/2005 8:35:35 PM PST by lizma
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To: lizma
How does a non-approved product like this make it to the market?

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."

FDA News

6 posted on 02/04/2005 9:06:30 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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