BEUDAMED
    FDA Enforcement Class II Terminated

    REGARD Core Biopsy Tray

    Recall: Z-0251-2022 · Reported November 24, 2021

    Enforcement

    Recall Number
    Z-0251-2022
    Event ID
    88463
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 24, 2021
    Initiation Date
    August 10, 2021
    Classification Date
    November 18, 2021
    Termination Date
    June 16, 2023
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    REGARD Core Biopsy Tray

    Reason

    Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.

    Code Info

    Lots numbers: 88004C, 87367C, 86986C, 83380C, 83062C, 82614C, 86178C and 85427C

    Distribution

    US Nationwide in the states of FL, LA and MO.

    Quantity

    1,200 trays