Regard — Class II medical device recall Z-0185-2016
Terminated recall by Resource Optimization & Innovation Llc, reported 2015-11-04, distributed in LA, TX. Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to comprom
| Recall number | Z-0185-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Resource Optimization & Innovation Llc, Springfield, MO, United States |
| Recall initiated | 2015-08-25 |
| Classified | 2015-10-29 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2017-04-06 |
| Distributed | LA, TX |
| Quantity | 80 kits |
| Reason classes | sterility, packaging |
| Model numbers | 830045, CV0443DCV |
Product
Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
Reason for recall
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
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-0185-2016. 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.