smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and… — Class I medical device recall Z-1274-2024
Ongoing recall by Smiths Medical ASD Inc., reported 2024-03-27, distributed nationwide. When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittent
| Recall number | Z-1274-2024 |
|---|---|
| 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 | 2024-02-07 |
| Classified | 2024-03-19 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BG, BH, BO, BR, CA, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FR, GB, GR, HK, ID, IE, IL, IN, IS, IT, JO, JP, KW, LB, MX, MY, NL, NO, NZ, OM, PA, PH, PK, PL, PT, QA, RO, SA, SE, SG, SI, SK, SV, TH, TR, TT, VN, ZA |
| Quantity | 10,140 units |
| Reason classes | device malfunction |
| Serial numbers | 1002250, 1007181, 1007187, 1009159, 1009160, 1009161, 1009162, 1009163, 1009186, 1009187, 1009188, 1009189, 1009190, 1009230, 1009231, 1009232, 1009233, 1009234, 1009235, 1009236, 1009237, 1009238, 1009239, 1010143, 1010144 and 475 more |
| Model numbers | P310NUS |
Product
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Reason for recall
When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.
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-1274-2024. 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.