FDAFDA · Food and drugs·Recall number Z-3208-2024
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Published October 9, 2024 · Recall initiated: August 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Percussionaire Corporation
- Distributor
- US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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