BEUDAMED
    FDA Enforcement Class I Ongoing

    Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

    Recall: Z-2139-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2139-2026
    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 64038301; 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 10193489059168, UDI/DI case 30193489059162, Lot Numbers: 89631, 92244, 92464, 93148, 94033, 94851, 101093, 101989, 103550, 109976, 112236, 112333, 114288, 115691, 121707, 126993, 137933, 142147, 162786, 191812,

    Distribution

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

    Quantity

    38175 units