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Recall Observatory FDA recall evidence

Device product

Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

Z-3208-2024

August 21, 2024

Class I

Product summary

Firm
Percussionaire Corporation
Event
Event 95239
Status
Ongoing
Classification
Class I
Quantity
2523 units
Official record key
device-enforcement:Z-3208-2024

Official wording

Reason: Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

Code information: No UDI/Lots: 240620 240610 240418 240326 230612 WO07066 WO07010 WO06020 WO05019 WO04884 WO04827 WO04756 WO04714 WO04656 WO04625 WO04596 WO04553 WO04398 WO04356 WO04061 WO03846 WO03748 WO03688

Distribution pattern: US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.