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IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug
Sentec/Percussionaire is updating use instructions for the Phasitron 5 In-Line Valve due to an increase in reports of patient injuries after users failed to remove the blue plug from the expiratory port when applying therapy directly to a patient’s airway. Failure to remove this cap during direct airway therapy can lead to the patient receiving too much pressure from the ventilator.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without following the updated instructions.
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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