Class II — Resource Optimization & Innovation Llc
| Recalling firm | Resource Optimization & Innovation |
|---|---|
| Registered facility | Resource Optimization & Innovation, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. |
| Product | Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery. |
| Quantity | 77 kits |
| Distribution | Distributed in Texas and Louisiana. |
| Initiated | 2015-08-25 |
| Classified | 2015-10-29 |
| Terminated | 2017-04-06 |
| Recall number | Z-0186-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Resource Optimization & Innovation Llc (Z-0186-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72052/
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