Bunnell Incorporated will voluntarily initiate a nationwide recall notification of Life Pulse High-Frequency Ventilator Patient Circuits. A complete list of Lot numbers affected by the recall is identified in the recall notice and on Bunnell’s website, www.bunl.com.
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 5,771 Patient Circuits distributed. There have been no reports of patient injury or death. However, out of an abundance of caution Bunnell 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 U.S. Food and Drug Administration to resolve this issue.
Bunnell will notify customers via certified mail and will post the recall notification and other important information at www.bunl.com.
http://www.fda.gov/Safety/Recalls/ucm330842.htm
