Health knowledge made personal
Join this community!
› Share page:
Search posts:

Bunnell Incorporated Issues Nationwide Recall Notification of Life Pulse High-Frequency Ventilator Patient Circuits

Posted Dec 05 2012 11:44am
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

1-800-800-4358 ext. 6  

FOR IMMEDIATE RELEASE - December 7 , 2012 - On December 12, 2012 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, .

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.  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 .

  • Customers with questions should contact Bunnell at 800-800-4358 ext. 6 between 8:00 AM and 4:00 PM (MST) Monday through Friday or via e-mail at .

Adverse reactions or quality problems experienced with the use of this product should be reported to Bunnell Inc. or the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax:

Post a comment
Write a comment:

Related Searches