BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1479-2018 · Initiated March 13, 2018

    Recall

    Recall Number
    Z-1479-2018
    Event Number
    79591
    Firm
    Medtronic Vascular
    FEI Number
    1220452
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    March 13, 2018
    Posted
    April 20, 2018
    Terminated
    May 7, 2021
    Address
    35-37A Cherry Hill Drive, Danvers, MA, 01923-2565

    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.

    Action

    Medtronic initiated consignee communications on 13-Mar- 2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. OUS communications were sent per locally approved methods. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic.

    Distribution

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

    Quantity

    855 units