FDA Device Recall Z-3208-2024

Percussionaire Corporation · Sandpoint, ID

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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

Lot / serial / GTIN: 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

Quantity: 2523 units

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.

Recall record

Recall number: Z-3208-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
Recall initiated: 2024-08-21
Classified by FDA Center: 2024-09-27
FDA published: 2024-10-09
Recalling firm: Percussionaire Corporation
Firm location: Sandpoint, ID

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls