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 | Ongoing |
| Reason | Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The label mix is at the unit level where a "ChloraPrep One-Step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "ChloraPrep With Tint" label. The recall notification was issued by BD on September 15, 2017 and was received by ROi on September 18, 2017. Because the 3ml ChloraPrep With Tint product is contained within select ROi Regard Custom Surgical Packs, ROi is conducting a recall of the affected ROi Regard Custom Surgical Packs. |
| Product | Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure. |
| Quantity | 51 units |
| Distribution | Distributed domestically to Texas. |
| Initiated | 2017-09-25 |
| Classified | 2017-11-21 |
| Recall number | Z-0169-2018 |
| 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-0169-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78377/
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