regard Clinical Packaging Solutions Item Number 830096005 — Class II medical device recall Z-0411-2022
Terminated recall by ROi CPS LLC, reported 2021-12-29, distributed in MO. The kit contains a non-sterile needle.
| Recall number | Z-0411-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2021-11-04 |
| Classified | 2021-12-22 |
| Reported by FDA | 2021-12-29 |
| Terminated | 2023-08-07 |
| Distributed | MO |
| Quantity | 40 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10194717112938 |
| Lot numbers | 90074 |
| Model numbers | 830096005, OB01054E |
| Expiration dates | 2023-04-17 |
Product
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Reason for recall
The kit contains a non-sterile needle.
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-0411-2022. 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.