regard Item Number: 800774001 — Class II medical device recall Z-1295-2022
Terminated recall by ROi CPS LLC, reported 2022-07-06, distributed nationwide. A nonsterile component was packaged in a sterile convenience kit.
| Recall number | Z-1295-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2022-05-20 |
| Classified | 2022-06-28 |
| Reported by FDA | 2022-07-06 |
| Terminated | 2023-05-02 |
| Distributed | Nationwide (US) |
| Quantity | 180 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10194717101949 |
| Lot numbers | 91423 |
| Model numbers | 800774001, CV00979ACV |
| Expiration dates | 2024-02-08 |
Product
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Reason for recall
A nonsterile component was packaged in a sterile convenience kit.
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-1295-2022. 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.