BEUDAMED
    FDA Enforcement Class II Terminated

    Regard, T AND A - Rogers, sterilized convenience kits

    Recall: Z-0469-2022 · Reported January 19, 2022

    Enforcement

    Recall Number
    Z-0469-2022
    Event ID
    89149
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 19, 2022
    Initiation Date
    November 30, 2021
    Classification Date
    January 10, 2022
    Termination Date
    August 7, 2023
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    Regard, T AND A - Rogers, sterilized convenience kits

    Reason

    Kits lacks rubber latex warning label.

    Code Info

    1) Item Number 8800313004, Lot Number 89090D (UDI 10194717110804); Expiration 07/15/2023 2) Item Number 8800313005, Lot Number 89378 (UDI 10194717112730); Expiration 08/05/2023

    Distribution

    US Nationwide distribution in the state of MO.

    Quantity

    195 kits