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Recall Observatory FDA recall evidence

Device product

Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

Z-3207-2024

August 21, 2024

Class I

Product summary

Firm
Percussionaire Corporation
Event
Event 95239
Status
Ongoing
Classification
Class I
Quantity
50,460 units
Official record key
device-enforcement:Z-3207-2024

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.