FDA: Bunnell Life Pulse High-Frequency Ventilator Patient Circuits Recalled

Bunnel Life Pulse High-Frequency Ventilator Patient Circuits have been recalled because the device’s melted insulation can lead to sparking and smoke, the U.S Food & Drug Administration (FDA) just announced.

The agency notified healthcare professionals and their provider organizations that the Bunnell Life Pulse High-Frequency Ventilator has been found to have heater wire insulation that can melt, causing sparking and smoke, close to the humidifier cartridge. This defect can lead to serious adverse consequences, including death.

Patient circuits are used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their physicians, failing on conventional ventilation.

The patient circuit provides a conduit for humidifying, warming, and temperature monitoring of the pressurized gas. The patient circuit is indicated for a seven-day single use.

The recalled patient circuits were distributed after March 19, 2012 through October 2012. Affected lot numbers are

12C092             12E211             12H330

12C102             12E224             12H349

12C115             12F241             12I362

12C125             12F254             12I371

12C136             12F271             12I397

12D159             12G279             12J413

12D172             12G290             12J430

12D189             12G307             12J448

12E204             12G321             12K457


On November 19, 2012, Bunnell sent its customers an Urgent: Medical Device Recall Notification letter by certified mail, which indicated the reason for the recall, the potential risk to health, and actions to be taken by the customer/user. The letter pointed out that while a recall has been issued, the firm is not replacing the defective circuits. The MedWatch Safety Alert, including a link to the Recall Notice, is available here.

All serious adverse events and product quality problems should be reported to the FDA MedWatch program at: www.fda.gov/medwatch/report.htm.


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