Recall Z-3208-2024— Percussionaire Corporation
Class I · Ongoing
Class I FDA medical device recall by Percussionaire Corporation, initiated 2024-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, 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..
- Recalling firm
- Percussionaire Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-08-21
- Firm location
- Sandpoint, ID, United States
Product description
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Reason for recall
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.