BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0693-2016 · Initiated December 15, 2015

    Recall

    Recall Number
    Z-0693-2016
    Event Number
    72926
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    FEI Number
    3001451489
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 15, 2015
    Posted
    January 27, 2016
    Terminated
    October 7, 2019
    Address
    920 Winter St, Waltham, MA, 02451-1521

    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).

    Action

    Fresenius Medical Care issued on December 15, 2015, a n Important Product Notification to all affected customers informing them of the problem and how to recognize the proper latch closing. Questions regarding the contents of the Customer Notification or questions regarding the issue, contact Technical Services at 1-800-227-2572 and reference the Field Action Number FA-2015-10-W. A reply form is included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy.

    Distribution

    Nationwide Distribution

    Quantity

    14,094 units