BEUDAMED
    FDA Enforcement Class II Completed

    Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

    Recall: Z-0439-2021 · Reported November 18, 2020

    Enforcement

    Recall Number
    Z-0439-2021
    Event ID
    86537
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2020
    Initiation Date
    September 12, 2020
    Classification Date
    November 7, 2020
    Address
    920 Winter St Bld 950, Waltham, MA, 02451-1521, United States

    Description

    Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

    Reason

    The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.

    Code Info

    All Liberty Select Cyclers with Software Version 2.9.0 Model Number 180343 and RTLR180343

    Distribution

    Distributed nationwide throughout the U.S and Puerto Rico. 9,907 devices currently in the field. 361 devices have been deactivated. 4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notice and response form.

    Quantity

    9,907 devices