The FDA has designated another CareFusion recall as Class I—the 11th time since the start of 2012 that the San Diego–based company has had a recall reach such a life-threatening level.
This time, the recall involves ventilators, an all-too-common device when it comes to serious recalls. CareFusion recalled the EnVe and ReVel ventilators, made between May 2009 and August 2014, because of the potential for damage to their power cord adaptors, which can cause loss of power and complete shut off, according to the FDA.
CareFusion received 256 reports of ventilators shutting off unexpectedly, but there were no reports of injuries or deaths, the FDA said.
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