BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30

    Recall: Z-1248-2021 · Reported March 17, 2021

    Enforcement

    Recall Number
    Z-1248-2021
    Event ID
    87284
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 17, 2021
    Initiation Date
    January 15, 2021
    Classification Date
    March 11, 2021
    Termination Date
    June 15, 2023
    Address
    35-37A Cherry Hill Drive, Danvers, MA, 01923-2565, United States

    Description

    Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30

    Reason

    Sterility may be compromised due to an unsealed pouch

    Code Info

    Lot Code: 220857555

    Distribution

    Nationwide

    Quantity

    137 units