Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP — Class I medical device recall Z-2974-2024
Ongoing recall by Smiths Medical ASD Inc., reported 2024-09-18. There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (10
| Recall number | Z-2974-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2024-05-31 |
| Classified | 2024-09-11 |
| Reported by FDA | 2024-09-18 |
| Quantity | 10,240 units |
| Model numbers | P310NXX |
Product
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2974-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.