Regard — Class II medical device recall Z-1376-2021
Ongoing recall by ROi CPS LLC, reported 2021-04-14, distributed nationwide. ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contai
| Recall number | Z-1376-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2021-03-04 |
| Classified | 2021-04-08 |
| Reported by FDA | 2021-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 16 kits |
| Reason classes | sterility |
| Lot numbers | 75818I |
| Model numbers | 830067009 |
| Expiration dates | 2021-05-18 |
Product
Regard, Item Number 830067009, custom cardiovascular procedure kit
Reason for recall
ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.
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-1376-2021. 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.