BEUDAMED
    FDA Enforcement Class I Ongoing

    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24

    Recall: Z-1285-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1285-2025
    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, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24

    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 10610586012747, Lot Numbers: 4317077

    Distribution

    Worldwide distribution.

    Quantity

    12 units