Carefusion Initiates Class I Recall Of EnVe Ventilators
MedSun: Newsletter #66, November 2011
Carefusion Press Release
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. 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. On September 12, the company sent an urgent Medical Device Recall Notification to customers stating the identified potential risks associated with the EnVe ventilators.
Carefusion Initiates Class I Recall Of EnVe Ventilators. Carefusion Press Release. October 20, 2011.