BEUDAMED
    FDA Enforcement Class II Terminated

    regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit

    Recall: Z-0293-2023 · Reported November 30, 2022

    Enforcement

    Recall Number
    Z-0293-2023
    Event ID
    91069
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 30, 2022
    Initiation Date
    October 20, 2022
    Classification Date
    November 23, 2022
    Termination Date
    April 1, 2026
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit

    Reason

    Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

    Code Info

    UDI/DI 10194717079958, Lot Numbers: 92037, exp 1/31/2023; 91205, exp 6/30/2023

    Distribution

    LA, MO, NC, FL

    Quantity

    200 kits