Recall archive / FDA device enforcement
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123 — FDA record Z-0637-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 12, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
- Reason
- 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
- Classification
- Class I
- Recalling firm
- Percussionaire Corporation
- Quantity
- 2145 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0637-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 24, 2024
- Recall initiation date
- Dec 12, 2023
- Center classification date
- Jan 17, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.