On December 12, 2012 Bunnell Inc voluntarily initiated a nationwide recall notification of Life Pulse high-frequency ventilator patient circuits.
The product has been found to have heater wire insulation that can melt, causing sparking and smoke close to the humidifier cartridge. There have been 12 reported failures out of 5,743 patient circuits distributed, but no reports of patient injury or death. The company stated that “out of an abundance of caution” it wants clinicians to be aware of the potential that a patient circuit failure could result in patient injury or death.
Bunnell is working with the FDA to resolve this issue. Find a complete list of lot numbers affected by the recall on Bunnell’s Web site.
Click here to read the FDA notice.
Weekly Jolt, December 18, 2012