CareFusion Updates Ventilator Recall

CareFusion has issued an update regarding the recall of its 128 EnVe ventilators affecting 29 customers.

The FDA has classified this action as a Class I recall, which is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.

The voluntary recall only affects EnVe ventilators manufactured between December 2010 and May 2011 and has no affect on current product production or shipping processes, according to the San Diego, Calif.-based firm.

On Sept. 12, the company sent an urgent Medical Device Recall Notification to customers outlining the potential risks, including a potential delay in resuming ventilation after reconnection, 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. In the notification letter, customers were provided serial numbers of affected devices.

More information is available at http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-enve-ventilator.aspx.

CareFusion is conducting a field corrective action to update the hardware and software on affected ventilators. The company reported that is has determined the root cause for each issue.