FDA Device recall Z-0169-2018
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure
- FDA Device
- Class II
- ongoing
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class II recall of Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure by Resource Optimization And Innovation, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0169-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-09-25 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Resource Optimization And Innovation |
| Distribution | TX |
Product
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
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.
Identifiers
| code_info | Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0169-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.