Class I
Medical Device Recall: Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Percussionaire Corporation · August 21, 2024
Reason for Recall
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Distribution
US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
States Affected
NATIONWIDE
Quantity Affected
50,460 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3207-2024
Status: ongoing
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