Recall archive / FDA device enforcement
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX — FDA record Z-2974-2024
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 May 31, 2024. 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
- Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
- Reason
- There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
- Classification
- Class I
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 10,240 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2974-2024
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 | All serial numbers |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 18, 2024
- Recall initiation date
- May 31, 2024
- Center classification date
- Sep 11, 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.