BEUDAMED
    FDA Recall Open, Classified

    Dialyzer Optiflux 160NRe

    Recall: Z-0801-2025 · Initiated December 5, 2024

    Recall

    Recall Number
    Z-0801-2025
    Event Number
    95884
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KDI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 5, 2024
    Posted
    January 3, 2025
    Address
    920 Winter St, Bld 920, Waltham, MA, 02451-1521

    Description

    Dialyzer Optiflux 160NRe

    Reason

    Potential for internal blood leaks due to cracked polyurethane

    Action

    Fresenius Medical Care notified consignees on about 12/05/2024 via URGENT MEDICAL DEVICE RECALL letter. Consignees were instructed to stock immediately for either of the affected lot numbers, immediately discontinue use of Optiflux F160NRe Dialyzer(s) with lot codes, place any of the affected units in a secure, segregated area, arrange for return of affected product and complete and return the provided Reply Form. Additionally, consignees were instructed to forward the notification to any personnel within the organization or to customers where product was further distributed.

    Distribution

    Nationwide Distribution.

    Quantity

    5,351 cases (64,212 dialyzers)