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Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR-4 Phasitron Breathing Circuits Due to Venturi Component Malfunctions that May Reduce Pressure and Volume Flow
Sentec/Percussionaire is recalling Phasitron breathing circuit kits after receiving a customer complaint that the venturi component of the kit stopping moving (oscillating) during use. The issue caused a patient’s oxygen levels to fall (desaturate). The risk of failure is especially high for pediatric patients due to the low pressures that are associated with this component failure.
The FDA has identified this as a Class I recall, the most serious type of recall. This recall involves removing certain devices from where they are used or sold. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact Sentec/Percussionaire customer service at FSCA@sentec.com.
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