BEUDAMED
    FDA Enforcement Class I Terminated

    REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

    Recall: Z-0269-2019 · Reported November 14, 2018

    Enforcement

    Recall Number
    Z-0269-2019
    Event ID
    81164
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    OriGen Biomedical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 14, 2018
    Initiation Date
    March 30, 2015
    Classification Date
    November 7, 2018
    Termination Date
    March 1, 2024
    Address
    7000 Burleson Rd Bldg D, Austin, TX, 78744-3202, United States

    Description

    REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

    Reason

    Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage

    Code Info

    Product Code UDI Lot VV19F 00816203022097 N18394

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain Sweden, Thailand and United Kingdom

    Quantity

    134