BEUDAMED
    FDA Enforcement Class II Terminated

    Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

    Recall: Z-1777-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1777-2020
    Event ID
    84109
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medivators, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2020
    Initiation Date
    October 9, 2019
    Classification Date
    April 23, 2020
    Termination Date
    December 11, 2020
    Address
    14605 28th Ave N, N/A, Plymouth, MN, 55447-4822, United States

    Description

    Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

    Reason

    Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.

    Code Info

    Lot # / Case UDI#s: 430358 / 2067796406530322060110430358, 429884 / 2067796406530322060110429884, 428806 / 2067796406530322070110428806, 430568 / 2067796406530322060110430568, 431254 / 2067796406530322070110431254, 431455 / 2067796406530322070110431455, 431603 / 2067796406530322070110431603, 431834 / 2067796406530322070110431834, 431985 / 2067796406530322070110431985, 431973 / 2067796406530322070110431973, 432922 / 2067796406530322070110432922, 432108 / 2067796406530322070110432108, 432921 / 2067796406530322070110432921, 433116 / 2067796406530322070110433116, 433115 / 2067796406530322080110433115.

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Australia, England.

    Quantity

    53,790 units total