Regard IV Start Kit for preparing and/or dressing a peripheral vein… — Class II medical device recall Z-0950-2022
Terminated recall by Resource Optimization & Innovation LLC, reported 2022-04-27, distributed in MO. A kit component, the PDI Prevantics Swab, was recalled.
| Recall number | Z-0950-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Resource Optimization & Innovation LLC, Saint Louis, MO, United States |
| Recall initiated | 2022-02-28 |
| Classified | 2022-04-18 |
| Reported by FDA | 2022-04-27 |
| Terminated | 2022-05-24 |
| Distributed | MO |
| Quantity | 3,570 kits |
| UPC / GTIN / UDI-DI | 20326053105252, 20326053105269 |
| Lot numbers | 272394, 272723, 272920, 273102, 273243, 273244, 273589, 273982, 274119, 274222, 275005, 275120, 275462, 275515, 275700, 276078, 276185, 276342, 276890, 276898, 277198, 277476, 277650, 277665, 278195, 278702, 278984, 279240, 279246, 279353, 279592, 279597, 281107, 281116, 281378, 281577, 281951, 282148, 282456, 282546 and 32 more |
| Model numbers | 303403REG, 303404REG, 57931 |
Product
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Reason for recall
A kit component, the PDI Prevantics Swab, was recalled.
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-0950-2022. 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.