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 | The kits contain an equipment glove component which may contain splits or holes compromising the sterility. |
| Product | regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure |
| Quantity | 924 kits |
| Distribution | Distribution was made to LA, MS, and TX. |
| Initiated | 2015-04-22 |
| Classified | 2015-10-07 |
| Terminated | 2017-03-28 |
| Recall number | Z-0096-2016 |
| 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-0096-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71904/
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