BEUDAMED
    FDA Enforcement Class II Terminated

    regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

    Recall: Z-1255-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1255-2022
    Event ID
    90199
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 15, 2022
    Initiation Date
    May 3, 2022
    Classification Date
    June 9, 2022
    Termination Date
    June 27, 2022
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758, United States

    Description

    regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

    Reason

    Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.

    Code Info

    UDI (01)10194717102335(17)230531(10)90135, Lot Number 90135, Exp. 2023-05-31

    Distribution

    FL

    Quantity

    24 kits