smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP… — Class I medical device recall Z-1275-2024
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-1275-2024 |
|---|---|
| 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 | 2,902 units |
| Reason classes | device malfunction |
| Serial numbers | 1007188, 10328, 1206210, 1206211, 1206212, 1206213, 1206214, 1206235, 1206236, 1206237, 1206238, 1210166, 1303220, 1303228, 1303229, 1303230, 1303231, 1303232, 1303233, 1303234, 1304223, 1304224, 1304225, 1304226, 1304227 and 475 more |
| Model numbers | P300NUS |
Product
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
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-1275-2024. 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.