Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Published November 29, 2017 · Recall initiated: September 25, 2017
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Resource Optimization & Innovation Llc
- Distributor
- Distributed domestically to Texas.
- Lot
- Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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