FDA recall Z-0169-2018

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.

Distribution

Distributed domestically to Texas.

Key facts

Status

Ongoing

Initiation date

2017-09-25

Report date

2017-11-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Springfield, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0169-2018