BEUDAMED
    FDA Enforcement Class I Ongoing

    Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

    Recall: Z-2138-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2138-2026
    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 64038200; 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 10193489059144, UDI/Di case 30193489059148, Lot Numbers: 90184, 94779, 97786, 106351, 108597, 109876, 114056, 114989, 115459, 115931, 116358, 116865, 118245, 122974, 126077, 127795, 129531, 130557, 136114, 150501, 151591, 152772, 154514, 156045, 160318, 163255, 168053.

    Distribution

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

    Quantity

    7075 units