FDA Device recall Z-3207-2024
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only
- FDA Device
- Class I
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class I recall of Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only by Percussionaire, citing updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3207-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-08-21 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Percussionaire |
| Distribution | US |
Product
Percussionaire, Inc., REF: P5-TEE, Qty: 1, 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.
Identifiers
| code_info | No UDI/ Lots: 240620, 240610, 240418, 240326, 230612, WO07066, WO07010, WO06020, WO05019, WO04884, WO04827, WO04756, WO…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3207-2024%22
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