BEUDAMED
    FDA Enforcement Class II Terminated

    Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

    Recall: Z-0179-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0179-2019
    Event ID
    80930
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OriGen Biomedical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 24, 2018
    Initiation Date
    August 21, 2018
    Classification Date
    October 18, 2018
    Termination Date
    July 15, 2021
    Address
    7000 Burleson Rd Bldg D, N/A, Austin, TX, 78744-3202, United States

    Description

    Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

    Reason

    These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip

    Code Info

    UDI: 00816203022059, Lot: N18687, N18687-1, R19506, S19746, S19760, S19761, S19772, S19781, S19880, N18549, N18573

    Distribution

    Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Thailand, UK, United Arab Emirates, and VIETNAM.

    Quantity

    1517