Pneupac paraPac plus 300 ventilator kit — Class III medical device recall Z-0163-2022
Terminated recall by Smiths Medical ASD Inc., reported 2021-11-03. Two devices were labeled with the same serial number
| Recall number | Z-0163-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2021-07-15 |
| Classified | 2021-10-22 |
| Reported by FDA | 2021-11-03 |
| Terminated | 2023-08-11 |
| Countries outside the US | GB |
| Quantity | 2 units |
| Reason classes | labeling |
| Model numbers | P300NGB |
Product
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Reason for recall
Two devices were labeled with the same serial number
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-0163-2022. 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.