Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Reported: October 9, 2024 Initiated: August 21, 2024 #Z-3207-2024
Product Description
Percussionaire, Inc., REF: P5-TEE, Qty: 1, 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.
Details
- Recalling Firm
- Percussionaire Corporation
- Units Affected
- 50,460 units
- Distribution
- US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
- Location
- Sandpoint, ID
Frequently Asked Questions
What product was recalled? ▼
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve. Recalled by Percussionaire Corporation. Units affected: 50,460 units.
Why was this product recalled? ▼
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2024. Severity: Critical. Recall number: Z-3207-2024.
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