Covidien’s (NYSE:COV) recall of its Puritan 980 ventilator just 8 months after its clearance for the U.S. market earned the FDA’s highest-level Class I status for “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
A programming glitch in models of the ventilators using the 2.8 software version may stop working after the air and oxygen supplies are disconnected and then reconnected, the FDA said last week. The Oct. 1 recall covers Puritan 980 devices made between March 3 and August 19 and distributed up until August 22, according to the FDA.
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