BEUDAMED
    FDA Recall Terminated

    STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2

    Recall: Z-0641-2021 · Initiated November 3, 2020

    Recall

    Recall Number
    Z-0641-2021
    Event Number
    86763
    Firm
    GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR
    FEI Number
    3014749926
    Product Code
    OCX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 3, 2020
    Terminated
    September 3, 2021

    Description

    STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2

    Reason

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

    Action

    GA Health Company Limited ( referred to as GA Health) issued URGENT: MEDICAL DEVICE RECALL notification letters is sent to affected direct consignees via email on 11/3/20 . The letter sent together with Recall Notice to Physician and Acknowledgement and Receipt Form which allows direct consignee to distribute to customer and collects feedback from direct consignee respectively. Actions to be Taken by the Distributor To facilitate quarantine of affected lots, GA Health recommends the following: " Review the device model and lot number below to identify and quarantine stock remained in your warehouse. Send the Recall Notice to Physician if you have already distributed the device to hospitals or clinics. " Return the Acknowledgement and Receipt Form to us within 7 calendar days upon receipt of this letter. " Discard the affected stock in you and your customers warehouse. Have the customers return any affected product to you, discard it also in your warehouse within 30 days upon receipt of this letter. " To discard the product, complete the enclosed RMA Form and complete scrap declaration. Return these two documents to your GA Health sales representative at [email protected] within 30 days upon receipt of this letter. This will allow us to document the amount of product you will scrap for follow up arrangement. Should you have questions about this issue, contact [email protected] or by phone at +852 2833 9010.

    Distribution

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

    Quantity

    11,000 units