FDASeptember 25, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

resource optimization innovationresourceresource optimization

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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