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

Date of Recall

2012-12-05

Recall Details

-December 5 , 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, 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.

• 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 [email protected].

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:

• Online at http://www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form
• Call FDA 1-800-FDA-0178

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