BEUDAMED
    FDA Recall Terminated

    Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide

    Recall: Z-1817-2017 · Initiated October 20, 2016

    Recall

    Recall Number
    Z-1817-2017
    Event Number
    75890
    Firm
    Micromedics, Inc.
    FEI Number
    2183425
    Product Code
    KGZ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 20, 2016
    Terminated
    July 23, 2019
    Address
    1270 Eagan Industrial Rd, Ste 120, Saint Paul, MN, 55121-1385

    Description

    Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide

    Reason

    The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance.

    Action

    A Medical Device Recall Letter was sent to customers beginning 10/20/2016 via Federal Express in the US and via UPS ground in Israel. The letter identified the affected device and lot number, issue, asked for product to be discontinued from use, quarantine and notify Nordson Medical, via a response form. Response form can be faxed back at 888-504-0606, email to [email protected] or mailed to Nordson Medical, 1270 Eagan Industrial Road, Suite 120, St. Paul, MN 55121.

    Distribution

    AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel

    Quantity

    273 units