BEUDAMED
    FDA Enforcement Class I Terminated

    OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter 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 of six hours or less.

    Recall: Z-1456-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1456-2015
    Event ID
    70988
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    OriGen Biomedical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 29, 2015
    Initiation Date
    March 30, 2015
    Classification Date
    April 23, 2015
    Termination Date
    May 3, 2016
    Address
    7000 Burleson Rd, Bldg D, Austin, TX, 78744-3202, United States

    Description

    OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter 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 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

    Lot N18549

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Spain, UK, Germany, Sweden, and Netherlands.

    Quantity

    51 units