BEUDAMED
    FDA Enforcement Class II Terminated

    Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

    Recall: Z-0658-2019 · Reported December 26, 2018

    Enforcement

    Recall Number
    Z-0658-2019
    Event ID
    81598
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2018
    Initiation Date
    November 5, 2018
    Classification Date
    December 20, 2018
    Termination Date
    April 17, 2023
    Address
    920 Winter St, Waltham, MA, 02451-1521, United States

    Description

    Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

    Reason

    Potential for external blood leaks from the dialyzer header

    Code Info

    Lot Numbers: 18HU06016, 18HU06017, 18HU06018 and 18HU06019

    Distribution

    US Nationwide

    Quantity

    9,097 cs x 12 units each