BEUDAMED
    FDA Enforcement Class II Terminated

    MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.

    Recall: Z-0051-2017 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-0051-2017
    Event ID
    75213
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Argon Medical Devices, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 12, 2016
    Initiation Date
    September 8, 2016
    Classification Date
    October 6, 2016
    Termination Date
    June 7, 2017
    Address
    1445 Flat Creek Rd, N/A, Athens, TX, 75751-5002, United States

    Description

    MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.

    Reason

    The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath

    Code Info

    11149662, 11151447, 11151617, and 11149822.

    Distribution

    Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.

    Quantity

    200 units