Z-3207-2024 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
50,460 units

Product Description

Percussionaire, Inc., REF: P5-TEE, Qty: 1, 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