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 | Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance. |
| Product | Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures. |
| Quantity | 24 kits |
| Distribution | Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC. |
| Initiated | 2015-08-19 |
| Classified | 2015-09-21 |
| Terminated | 2017-04-05 |
| Recall number | Z-2798-2015 |
| 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-2798-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72008/
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