HIV Fears Prompt Recall of Product for Burn VictimsJul 23, 2001
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.