BEUDAMED
    FDA Recall Terminated

    Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.

    Recall: Z-0148-2014 · Initiated October 14, 2013

    Recall

    Recall Number
    Z-0148-2014
    Event Number
    66339
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 14, 2013
    Posted
    November 5, 2013
    Terminated
    May 18, 2021
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.

    Reason

    Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis

    Action

    Fresenius Medical Care contacted all affected consignees by telephone on 10/14/13 to inform them of the product safety alert. Follow-up Urgent Safety Alert letter was sent on 10/18/13 and 10/23/13 by Certified Mail, Return Receipt requested. The letter identified the affected product, problem and actions to be taken. Customers were instructed to report any events associated with this safety alert to Customer Service Team at 1-800-323-5188.

    Distribution

    USA Nationwide Distribution

    Quantity

    16,600