FDA Deems CareFusion Ventilator Defect High-Risk

Law360, New York (October 19, 2011, 6:11 PM EDT) -- CareFusion Corp. said Wednesday that the U.S. Food and Drug Administration had classified its callback of faulty ventilators for intensive care patients a Class I recall, a designation saved only for defective products that pose the risk of serious injury or death.

The medical device manufacturer began warning customers in mid-September that EnVe ventilators manufactured from  December 2010 to May could potentially interrupt air flow to patients and result in serious neurological injury or death. The recall affects 128 EnVe ventilators and 29 customers.

"CareFusion discovered...
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