paraPAC 300 ventilator kit without internal PEEP and CPAP — Class I medical device recall Z-3091-2024
Ongoing recall by Smiths Medical ASD Inc., reported 2024-10-02. Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/deta
| Recall number | Z-3091-2024 |
|---|---|
| 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 | 2024-09-20 |
| Reported by FDA | 2024-10-02 |
| Quantity | 3,182 units |
| Reason classes | device malfunction |
| Serial numbers | 1007188, 10328, 1102432, 1102433, 1206210, 1206211, 1206212, 1206213, 1206214, 1206235, 1206236, 1206237, 1206238, 1210164, 1210165, 1210166, 1303220, 1303228, 1303229, 1303230, 1303231, 1303232, 1303233, 1303234, 1304223 and 475 more |
| Model numbers | P300N |
Product
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
Reason for recall
Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
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-3091-2024. 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.