FDA Enforcement
Class I
Ongoing
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Recall: Z-3208-2024
·
Reported October 9, 2024
Enforcement
- Recall Number
- Z-3208-2024
- Event ID
- 95239
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Percussionaire Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 9, 2024
- Initiation Date
- August 21, 2024
- Classification Date
- September 27, 2024
- Address
- 130 Mcghee Rd Ste 109, N/A, Sandpoint, ID, 83864-8409, United States
Description
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Reason
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
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
Distribution
US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
Quantity
2523 units