BEUDAMED
    FDA Enforcement Class I Terminated

    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F

    Recall: Z-1230-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1230-2019
    Event ID
    82512
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    OriGen Biomedical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2019
    Initiation Date
    January 17, 2017
    Classification Date
    June 4, 2019
    Termination Date
    July 27, 2021
    Address
    7000 Burleson Rd Bldg D, Austin, TX, 78744-3202, United States

    Description

    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F

    Reason

    Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.

    Code Info

    Lots: N18573, N18687-1

    Distribution

    US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile

    Quantity

    145