BEUDAMED
    FDA Recall Open, Classified

    SenSight Connector Plug, Model Number B31061.

    Recall: Z-0121-2024 · Initiated January 20, 2023

    Recall

    Recall Number
    Z-0121-2024
    Event Number
    93083
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    January 20, 2023
    Posted
    October 18, 2023
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    SenSight Connector Plug, Model Number B31061.

    Reason

    Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label.

    Action

    Medtronic issued a MEDICAL DEVICE REMOVAL notice to its consignees on 01/20/2023 by mail. Consignees were asked to return any affected product they may have, and to forward this notification to those who need to be aware within the organization or to any location which the devices have been transferred.

    Distribution

    US Nationwide Distribution

    Quantity

    65 devices