BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0169-2018 · Reported November 29, 2017

    Enforcement

    Recall Number
    Z-0169-2018
    Event ID
    78377
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Resource Optimization & Innovation Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 29, 2017
    Initiation Date
    September 25, 2017
    Classification Date
    November 21, 2017
    Address
    2909 N Neergard Ave, N/A, Springfield, MO, 65803-6317, United States

    Description

    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.

    Code Info

    Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019

    Distribution

    Distributed domestically to Texas.

    Quantity

    51 units