Bunnell recalls ventilator circuits over melting risk

December 28, 2012 by MassDevice staff

FDA slaps Bunnell Inc.’s Life Pulse High-Frequency Ventilator Patient Circuits with Class I status over concerns that the heater wire may fail when treating ventilating critically ill infants.

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Salt Lake City, Utah-based medical maker Bunnell Inc. this month launched a nationwide recall of its Life Pulse High-Frequency Ventilator Patient Circuits after receiving failure reports among certain lots.

Bunnell received reports of failure for 12 out of 5,743 circuits, which are used for ventilating critically ill infants with pulmonary interstitial emphysema and those with respiratory distress syndrome.

The circuits provides a conduit for the humidification, warming, and temperature monitoring of the pressurized gas, according to an FDA notice.

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