FDA Medical devices recall ·
Percussionaire, Inc recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-3208-2024
- Date
- (initiated August 21, 2024)
- Company / brand
- Percussionaire Corporation
130 Mcghee Rd Ste 109, Sandpoint, ID, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 2523 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Why was it recalled?
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-3208-2024. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.