Regard Custom Surgical Pack Packs contain surgical instruments and… — Class II medical device recall Z-0169-2018
Ongoing recall by Resource Optimization & Innovation Llc, reported 2017-11-29, distributed in TX. Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml C
| Recall number | Z-0169-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Resource Optimization & Innovation Llc, Springfield, MO, United States |
| Recall initiated | 2017-09-25 |
| Classified | 2017-11-21 |
| Reported by FDA | 2017-11-29 |
| Distributed | TX |
| Quantity | 51 units |
| Reason classes | labeling |
| Lot numbers | 047005C |
| Model numbers | 800620003 |
| Expiration dates | 2019-08-15 |
Product
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Reason for recall
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.
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-0169-2018. 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.