Convenience kits containing regard IV Start Kits: — Class II medical device recall Z-1005-2022
Terminated recall by ROi CPS LLC, reported 2022-05-04, distributed nationwide. A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of
| Recall number | Z-1005-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2022-03-18 |
| Classified | 2022-04-26 |
| Reported by FDA | 2022-05-04 |
| Terminated | 2024-08-02 |
| Distributed | Nationwide (US) |
| Quantity | 1,501 convenience |
| Lot numbers | 84799C, 86155C, 86735C, 87230M, 87269C, 87871C, 87954M, 88285M, 88564C, 88999M, 89260, 89494, 89820, 89985, 90253, 90594, 90866, 91335, 91603 |
| Model numbers | 830015013, 830084003, LD00200M, LD00866C |
| Expiration dates | 2022-03-31, 2022-05-31, 2022-06-30, 2022-07-31, 2022-12-31, 2023-01-31, 2023-02-28, 2023-05-31 |
Product
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.
Reason for recall
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
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-1005-2022. 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.