FDA Medical devices recall ·
Percussionaire, Inc recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-3207-2024
- 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
- 50,460 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Percussionaire, Inc., REF: P5-TEE, Qty: 1, 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-3207-2024. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.