Z-3208-2024 Class I Ongoing

Recalled by Percussionaire Corporation — Sandpoint, ID

Recall Details

Product Type
Devices
Report Date
October 9, 2024
Initiation Date
August 21, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2523 units

Product Description

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

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 Pattern

US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey

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