BEUDAMED
    FDA Enforcement Class II Terminated

    STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229

    Recall: Z-0639-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0639-2021
    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

    STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229

    Reason

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

    Code Info

    Lot Numbers: 19121831, 20032007 Unit UDI: 04897106951093 Box UDI: 14897106951090 Carton Box UDI: 24897106951097

    Distribution

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

    Quantity

    12,800 units