BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.

    Recall: Z-1479-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1479-2018
    Event ID
    79591
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    March 13, 2018
    Classification Date
    April 20, 2018
    Termination Date
    May 7, 2021
    Address
    35-37A Cherry Hill Drive, N/A, Danvers, MA, 01923-2565, United States

    Description

    Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.

    Reason

    The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.

    Code Info

    UDI 20643169689309, Lot Number 60074805

    Distribution

    US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,

    Quantity

    855 units