BEUDAMED
    FDA Recall Open, Classified

    MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites

    Recall: Z-0675-2024 · Initiated November 28, 2023

    Recall

    Recall Number
    Z-0675-2024
    Event Number
    93617
    Firm
    Cordis US Corp
    FEI Number
    1016427
    Product Code
    MGB
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    November 28, 2023
    Posted
    January 5, 2024
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    MYNXGRIP 6F/7F, REF MX6721, 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.

    Action

    Cordis issued an Urgent MEDICAL DEVICE RECALL notice to its consignees on 11/28/2023 via via FEDEX. The notice explained the issue and requested the return of any affected product in inventory. For questions related to the recall and/or acknowledgement form that are not adequately addressed in the letter, please contact Cordis QA at: [email protected] or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.

    Distribution

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

    Quantity

    70 units