BEUDAMED
    FDA Enforcement Class II Ongoing

    MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.

    Recall: Z-0674-2024 · Reported January 17, 2024

    Enforcement

    Recall Number
    Z-0674-2024
    Event ID
    93617
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cordis US Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 17, 2024
    Initiation Date
    November 28, 2023
    Classification Date
    January 5, 2024
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802, United States

    Description

    MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.

    Reason

    Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.

    Code Info

    UDI/DI 10862028000403, Lot numbers: F2322902

    Distribution

    US: NC, WV, TN, MS, MI, OH, CA

    Quantity

    50 units