BEUDAMED
    FDA Recall Open, Classified

    smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24

    Recall: Z-1287-2025 · Initiated February 13, 2025

    Recall

    Recall Number
    Z-1287-2025
    Event Number
    96294
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    3012307300
    Product Code
    LJT
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 13, 2025
    Posted
    March 18, 2025
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24

    Reason

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

    Action

    Smiths medical issued an URGENT MEDICAL DEVICE RECALL to its consignees on 02/13/2025 via letter delivered by traceable means. The notice explained the issue, potential risk, and requested the following: Required Actions for Customers 1. Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2. Please return all affected product. 3. Inform all potential users of the product in your organization of this notification and complete and return the attached response form to [email protected] within ten days of receipt to acknowledge your understanding of this notification, even if you do not have the affected product and/or has already been used. 4. If you have distributed the product further, immediately notify your accounts that received the affected product and ask them to contact Sedgwick at 1-888-345-2656 (MF, 8am-5pm ET) to obtain a response form.

    Distribution

    Worldwide distribution.

    Quantity

    8515 units