Sentec/Percussionaire Breathing Circuit Recalled

Sentec/Percussionaire is recalling (Class 1) its Phasitron breathing circuit kits after receiving a complaint that the venturi component stopped oscillating during use, which caused a patient’s oxygen levels to fall. “The risk of failure is especially high for pediatric patients due to the low pressures that are associated with this component failure,” a recall notice says.

The use of a malfunctioning device may cause serious adverse health consequences, including acute respiratory failure, hypoxia, hypercapnia, potential brain damage, heart complications, increased risk of pneumonia, and death, the notice says. To date, no injuries related to the issue have been reported.  

The Phasitron breathing circuit kit is intended to be used for continuous, controlled ventilation of patients who are unable to breathe on their own, the notice says. The venturi component assists with the pulsing flow of air/oxygen patients.