BEUDAMED
    FDA Enforcement Class II Ongoing

    Dialyzer Optiflux 160NRe

    Recall: Z-0801-2025 · Reported January 15, 2025

    Enforcement

    Recall Number
    Z-0801-2025
    Event ID
    95884
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2025
    Initiation Date
    December 5, 2024
    Classification Date
    January 3, 2025
    Address
    920 Winter St Bld 920, Waltham, MA, 02451-1521, United States

    Description

    Dialyzer Optiflux 160NRe

    Reason

    Potential for internal blood leaks due to cracked polyurethane

    Code Info

    UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.

    Distribution

    Nationwide Distribution.

    Quantity

    5,351 cases (64,212 dialyzers)