BEUDAMED
    FDA Enforcement Class I Ongoing

    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24

    Recall: Z-1281-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1281-2025
    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, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24

    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 10610586012594, Lot Numbers: 3926119, 3928191, 3944833, 3960347, 3968098, 3988451, 4027913, 4057817, 4087000, 4139520, 4146467, 4173474, 4196758, 4221725, 4235599, 4256939, 4291484, 4295931, 4302979, 4307473, 4307474, 4437254, 4447572, 4449876, 4460619, 6037144, 6006017, 6059285, 6026682, 6062025, 6071258.

    Distribution

    Worldwide distribution.

    Quantity

    3263 units