The U.S. Food and Drug Administration is warning that certain CareFusion ventilators leave consumers with "a reasonable probability" of "serious adverse health consequences or death."
FDA updates CareFusion ventilator recall
The FDA classified a recall of some CareFusion Avea ventilators as "class one," which the agency defines as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death," according to the agency's website.
CareFusion, based in San Francisco, began in September a voluntary recall of Avea ventilators and spare parts manufactured between March 1, 2009, and June 30, 2011, the company said in a news release. In a letter to consumers in September, CareFusion said the malfunctioning devices may stop ventilating when the ventilator releases a safety valve after activating a false alarm. CareFusion said the company will update the devices for consumers.
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