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

    Recall: Z-0102-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0102-2019
    Event ID
    81098
    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 12, 2018
    Termination Date
    October 5, 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

    Reason

    The catheter failed the endotoxin testing.

    Code Info

    UDI: 00816203022059, lot N18687-1

    Distribution

    US Nationwide in the states of NY, AR, MO, NC, GA, LA, CO, AL, MA, CA, MI, TX, OH, MD, FL, TN, SC, OR, AZ, UT, RI, SD, PA, NM, CT. Foreign (OUS): United Arab Emirates, Kingdom of Saudi Arabia, New Zealand, Thailand

    Quantity

    106