Isolation Droplet Bundle Kit — Class II medical device recall Z-2465-2020
Terminated recall by ROi CPS LLC, reported 2020-07-08, distributed in LA, MO. Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labe
| Recall number | Z-2465-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2020-05-19 |
| Classified | 2020-06-26 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2020-09-01 |
| Distributed | LA, MO |
| Quantity | 24 kits |
| Reason classes | labeling |
| Lot numbers | 78253M |
| Model numbers | 830006013 |
Product
Isolation Droplet Bundle Kit
Reason for recall
Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the 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-2465-2020. 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.