CareFusion Hit with Another Class I RecallCareFusion Hit with Another Class I Recall

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.The recall, which places CareFusion in second place for most Class I recalls since the start of 2012, comes only days after Franklin Lakes, NJ-based Becton Dickinson announced it would buy CareFusion for $12 billion, in a deal expected to close during the first half of 2015.The EnVe and ReVel ventilators, used on patients who require respiratory support or mechanical ventilation, can be operated using either batteries or external power sources such as AC or auto lighters. CareFusion, though, found that the pins of the external power connector did not always align properly with the input port of the ventilator. Such misalignment can damage the pins and possibly short circuit the ventilator. A power supply short circuit may prevent the ventilator battery from recharging, and the ventilator could lose power unexpectedly.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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