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Brendon Nafziger, DOTmed News Associate Editor | October 15, 2010
The U.S. Food and Drug Administration said Friday an August recall of thousands of CareFusion Corporation drug pumps was a Class 1 recall, meaning the problem could lead to injury or death.
CareFusion yanked 17,000 Alaris infusion pumps off of the market in August as part of the recall. The company said it informed its customers of the problem Aug. 24.
According to the FDA's recall notice, the PC unit of the infusion pumps can freeze under certain wireless network conditions. While they continue to pump drugs, modifying the programming can cause the PC unit to shut down, and possibly delay delivery of drugs, which could be dangerous, the FDA said.
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The recall covers the Alaris PC model 8015 made between Dec. 20, 2008 and Sept. 8, 2009 and shipped between Dec. 20, 2008 and June 28, 2010.
The error requires a hardware update to fix and the company does not need the products to be returned, according to the FDA.
The San Diego, Calif.-based company said the recall wouldn't affect its current production and shipping.
