BEUDAMED
    FDA Recall 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 · Initiated September 8, 2016

    Recall

    Recall Number
    Z-0051-2017
    Event Number
    75213
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 8, 2016
    Posted
    October 7, 2016
    Terminated
    June 7, 2017
    Address
    1445 Flat Creek Rd, Athens, TX, 75751-5002

    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

    Action

    An Urgent - Product Recall Notice was sent to consignees identifying the affected device and the reason for the recall. Customers were asked to return all affected devices. The firm will send replacement devices upon receipt of the returned affected product and once assembly of a cleared lot that does not contain recalled devices has been completed. If there are questions regarding the letter or recall action, customers can contact [email protected].

    Distribution

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

    Quantity

    200 units