Regard Custom Procedure Kits containing BD Luer Lok Access Devices — Class III medical device recall Z-0837-2022
Terminated recall by ROi CPS LLC, reported 2022-04-06, distributed nationwide. Recalled devices were packaged in convenience kits.
| Recall number | Z-0837-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2022-02-24 |
| Classified | 2022-03-30 |
| Reported by FDA | 2022-04-06 |
| Terminated | 2022-04-25 |
| Distributed | Nationwide (US) |
| Quantity | 1,750 kits |
| Lot numbers | 87572, 89222, 90446, 90641, 91226 |
| Model numbers | 830110, 830110002, 87572, 89222, 90446, 90641, 91226 |
Product
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Reason for recall
Recalled devices were packaged in convenience kits.
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-0837-2022. 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.