Resource Optimization & Innovation product recalled over labeling errors

Recall date

September 25, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Resource Optimization & Innovation Llc recalls Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical proce…

Recall number

Z-0169-2018

FDA classification

Class II

Brand / firm

Resource Optimization & Innovation Llc

Sold / distributed

Distributed domestically to Texas.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.