BEUDAMED
    FDA Enforcement Class II Terminated

    Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

    Recall: Z-0693-2016 · Reported February 3, 2016

    Enforcement

    Recall Number
    Z-0693-2016
    Event ID
    72926
    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
    February 3, 2016
    Initiation Date
    December 15, 2015
    Classification Date
    January 27, 2016
    Termination Date
    October 7, 2019
    Address
    920 Winter St, N/A, Waltham, MA, 02451-1521, United States

    Description

    Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

    Reason

    The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).

    Code Info

    All lot numbers

    Distribution

    Nationwide Distribution

    Quantity

    14,094 units