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CareFusion Initiates Class I Recall of EnVe Ventilators

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Rich   Wednesday, 10/19/11 10:18:28 AM
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CareFusion Initiates Class I Recall of EnVe Ventilators
Today : Wednesday 19 October 2011

CareFusion (NYSE: CFN), a leading global medical device company, issued the following update regarding its recall of 128 EnVe™ ventilators affecting 29 customers. The FDA has classified this action as a Class I recall.

The voluntary recall only affects EnVe ventilators manufactured between December 2010 and May 2011 and therefore, has no affect on the company's current product production or shipping processes.

On September 12, the company sent an urgent Medical Device Recall Notification to customers stating the identified potential risks associated with the EnVe ventilators. The issues include: a potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection upon transport. Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.




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