Medical device company, CareFusion, recalls EnVe™ ventilators manufactured between December 2010 and May 2011. The FDA has classified this action as a Class I recall.
The company 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.
CareFusion is conducting a field corrective action to update the hardware and software on affected ventilators.
For details, please refer to the FDA website http://www.fda.gov/Safety/Recalls/ucm276704.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.