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FDA (Device enforcement)Recalled 2024-08-21class i

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

Hazard

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

Details from the source

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 Quantity: 2523 units Lot/code info: 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

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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