BEUDAMED
    FDA Enforcement Class I Ongoing

    Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

    Recall: Z-2140-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2140-2026
    Event ID
    98735
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 20, 2026
    Initiation Date
    March 24, 2026
    Classification Date
    May 8, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

    Reason

    Medline has identified the presence of particulate within the fluid path of the Manifolds.

    Code Info

    UDI/DI each 10193489059182, UDI/DI case 30193489059186, Lot Numbers: 92261, 152082, 163966, 163256.

    Distribution

    US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.

    Quantity

    1975 units