BEUDAMED
    FDA Enforcement Class I Ongoing

    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

    Recall: Z-1279-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1279-2025
    Event ID
    96294
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2025
    Initiation Date
    February 13, 2025
    Classification Date
    March 18, 2025
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

    Reason

    The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

    Code Info

    UDI/DI 10610586012549, Lot Numbers: 3928188, 3953708, 3957301, 3968097, 3977434, 3988450, 4006475, 4022600, 4027912, 4036893, 4073108, 4086999, 4103105, 4114110, 4122783, 4136362, 4139518, 4152689, 4153871, 4173433, 4189866, 4222392, 4227822, 4235597, 4276226, 4307472, 4317085, 4349806, 4378522, 4387732, 4395511, 4460618, 4434228, 4449233, 4449875, 6013082, 6014983, 4468606, 4426417, 6062037, 6071256.

    Distribution

    Worldwide distribution.

    Quantity

    2311 units