BEUDAMED
    FDA Enforcement Class II Terminated

    Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

    Recall: Z-0644-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0644-2021
    Event ID
    86763
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GA HEALTH COMPANY LIMITED
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2020
    Initiation Date
    November 3, 2020
    Classification Date
    December 18, 2020
    Termination Date
    September 3, 2021
    Address
    Unit 18, 21/F, Metropole Square; 2 On Yiu Street ,Shatin, N.T, Shatin N.T., N/A, N/A, Hong Kong SAR

    Description

    Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

    Reason

    Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

    Code Info

    Lot Numbers: 20021025, 20052901, 19102223, 19110721, 19120903, 19120909, 20021046, 20022803, 20030407, 20030408, 20030922, 20030923, 20031802, 20061806 Unit UDI: 04897106950263 Box UDI: 14897106950260 Cartoon Box UDI: 24897106950267

    Distribution

    US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.

    Quantity

    93,700 units