FDASeptember 17, 2025device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
percussionaire
UPCs
00849436000723
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAVDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidificatio...2024-12-23
- FDAPhasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy2024-09-16
- FDAPercussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve2024-08-21
- FDAPercussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve2024-08-21
- FDAHigh Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 01232023-12-12
- FDADistal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)2023-03-28
- FDAMonitron II Waveform Analyzer, REF: S00015-1, used with ventilators.2020-09-14
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