[pending] Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/
Pending LLM rewrite. Source: FDA_DEVICE Z-0031-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
The recalled product
- Product
- Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
- Manufacturer
- Percussionaire Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- UDI-DI: 00849436000723. Lots: 240326
- 250116
- 240418
- 250324
- 240610
- 250616
- 240620
- 241121
- 230612
- 240826
- WO04884
- 241118
- WO06020
- 241203
- WO05019
- 250111
- WO04827
- WO04756. Instructions for Use P20020 Rev F
Distribution
Distributed nationwide across the United States.
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