Regard — Class II medical device recall Z-2265-2020
Terminated recall by ROi CPS LLC, reported 2020-06-17, distributed nationwide. Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
| Recall number | Z-2265-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2020-04-20 |
| Classified | 2020-06-05 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2020-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 40 kits |
| UPC / GTIN / UDI-DI | 10326053106634 |
| Lot numbers | 68336DRW |
| Model numbers | 830034, GS0348D |
Product
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Reason for recall
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
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-2265-2020. 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.