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HIV Fears Prompt Recall of Product for
Burn Victims
http://wwwlawyer.com/articles/article5817.cfm
Baxter International Inc. on Monday said it has
recalled one lot of a
product that hospitals use to treat burn victims and
patients in shock
after a test found a rare form of HIV in the plasma
used to make the
product.
``This is being recalled for quality reasons, not
safety reasons,'' said
Tanya Tyska, a spokeswoman for the Deerfield,
Illinois-based health care
products company.
Tyska said subsequent evaluation using an experimental
test for HIV-2
detected
low levels of the virus in the plasma pool used to make the
product. HIV-2 is rare in the United States.
Baxter's voluntary recall of the product, known as
Albumin Buminate 5
percent,
was posted on Friday on the Web site of the US Food and Drug
Administration (FDA).
During processing, Albumin Buminate is subjected to
viral inactivation
pasteurization, a process shown to kill HIV.``The
manufacturing process
destroys the HIV virus. This recall is being taken as a
precautionary
measure only,'' Tyska said.
She said the product met FDA specifications for release
and no adverse
events have as yet been reported in association with
the lot. She declined
to say how much product was contained in the lot, but
said the company
will
replace the recalled product with current inventory.
Tyska said the company released the product in
February, while later
testing with the experimental test was done in the past
few weeks. She
said the company conducts a complete panel of tests on
its products.
``This may be one that we add,'' she said of the test,
which is used in
other countries but is considered investigational in
the United States
7/23/2001
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