BEUDAMED
    FDA Recall Terminated

    REGARD Basic Cataract tray

    Recall: Z-0250-2022 · Initiated August 10, 2021

    Recall

    Recall Number
    Z-0250-2022
    Event Number
    88463
    Firm
    ROi CPS LLC
    FEI Number
    3014527682
    Product Code
    OJK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 10, 2021
    Terminated
    June 16, 2023
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758

    Description

    REGARD Basic Cataract 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.

    Action

    The correction was sent via e-mail on 08-10-2021 instructing the consignees to removed the Swabsticks (3's) and be discarded at time of use.

    Distribution

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

    Quantity

    126 trays