BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1817-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1817-2017
    Event ID
    75890
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Micromedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    October 20, 2016
    Classification Date
    April 12, 2017
    Termination Date
    July 23, 2019
    Address
    1270 Eagan Industrial Rd Ste 120, N/A, Saint Paul, MN, 55121-1385, United States

    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.

    Code Info

    Lot Number: 163010 Expiration date: June 2021

    Distribution

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

    Quantity

    273 units