In a latest press release the U.S.F.D.A says that Bunnell Incorporated will voluntarily initiate a nationwide recall notification of Life Pulse High-Frequency Ventilator Patient Circuits. The recall will be in effect from December 12, 2012. The company has said that the move was taken after it found that the products have heater wire insulation that can melt, causing sparking and smoke close to the humidifier cartridge. The report has also confirmed that out of 5,771 circuits that were distributed, 12 were found to be defective and failed. Though no report of death or injury was found till date however, as a necessary precaution Bunnell wants clinicians to be aware of the potential that a Patient Circuit failure could result in patient injury or death.

Customers having questions and queries can 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 plattdr@bunl.com. Experiences of quality problems and adverse reactions could be reported to Bunnell Inc. or could also be reported through FDA’s MedWatch Adverse Event Reporting Program either by fax, mail or online. Those who are willing to convey their information online can do so at http://www.fda.gov/MedWatch/report.htm.

For those people who are willing to do voice call could do so by calling FDA at 1-800-FDA-0178. Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm.

About Bunnell:

The Company Bunnell Inc. was conceived and came into existence in the year 1980 and since then it has been serving the development of advanced ventilation systems for treating premature infants in acute respiratory failure, an often fatal complication of preterm birth. The Company manufactures, markets, and services its products for hospitals and health care facilities in the United States, Europe, Canada, Australia, Malaysia, Uruguay, and Trinidad and Tobago. Since its introduction, the Life Pulse® Ventilator has helped health care professionals save approximately 100,000 infants. The company offers inspired infant care with their revolutionary Life Pulse® Ventilator, the first high-frequency ventilator ever approved by the U.S. Food and Drug Administration (FDA) for clinical use (1988).

What is Life Pulse High-Frequency Ventilator Patient Circuits?

The medical device manufactured and marketed by Bunnell Inc is a High frequency ventilation device a type of mechanical ventilation which utilizes a respiratory rate greater than 4 times the normal value in very small tidal volumes. The devices are widely used across the United States to reduce ventilator-associated lung injury (VALI), especially in the context of ARDS and acute lung injury.