Regard CV PK — Class II medical device recall Z-0315-2024
Ongoing recall by ROi CPS LLC, reported 2023-11-22, distributed in MO. Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for
| Recall number | Z-0315-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2023-09-21 |
| Classified | 2023-11-16 |
| Reported by FDA | 2023-11-22 |
| Distributed | MO |
| Quantity | 134 units |
| UPC / GTIN / UDI-DI | 10194717111702, 10194717117049 |
| Lot numbers | 94114, 95436, 96442 |
Product
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Reason for recall
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
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-0315-2024. 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.