FDAFDA · Food and drugs·Recall number Z-3207-2024
Percussionaire, Inc., REF: P5-TEE, Qty: 1, 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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