FDADecember 12, 2023device
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user
What to do
FDA enforcement status: Ongoing
Brands named
percussionaire
UPCs
10849436000331
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPhasitron 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 Use2025-09-17
- 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
- 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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