BEUDAMED
    FDA Recall Open, Classified

    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF

    Recall: Z-1458-2025 · Initiated February 21, 2025

    Recall

    Recall Number
    Z-1458-2025
    Event Number
    96443
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    KDD
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    February 21, 2025
    Posted
    April 4, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF

    Reason

    Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

    Action

    Medline issued a MEDTRONIC MEDICAL DEVICE RECALL NOTICE to its consignees on 02/21/2025 via email. The notice explained the issue and potential risk. Upon receipt of the completed recall response form, over-labels will be provided, which are to be placed on kits that contain the recalled component and will state the affected component shall be removed and discarded from further use. Distributors, or those who have resold or transferred this product to another company or individual were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

    US: CA, FL, MN, NY, OH, OR, PA, TX, WV

    Quantity

    320 units