BEUDAMED
    FDA Enforcement Class II Terminated

    STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1

    Recall: Z-0640-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0640-2021
    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 Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1

    Reason

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

    Code Info

    Lot Numbers: 19121830, 20031604 Unit UDI: 04897106951109 Box UDI: 24897106951103 Carton Box UDI: 24897106951103

    Distribution

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

    Quantity

    25,000 units