Bunnell Life Pulse High-Frequency Ventilator Patient Circuits: Recall
MedSun: Newsletter #80, January 2013

FDA MedWatch Safety Alert

This product has been found to have heater wire insulation that can melt, causing sparking and smoke, close to the humidifier cartridge. This can cause serious adverse consequences, including death. On November 19, 2012, Bunnell sent its customers an urgent medical device recall notification letter by certified mail.

Additional Information:

FDA MedWatch Safety Alert. Bunnell Life Pulse High-Frequency Ventilator Patient Circuits: Recall. December 21, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333262.htm