BEUDAMED
    FDA Recall Terminated

    Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.

    Recall: Z-1674-2013 · Initiated June 3, 2013

    Recall

    Recall Number
    Z-1674-2013
    Event Number
    65332
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    June 3, 2013
    Posted
    July 10, 2013
    Terminated
    June 18, 2014
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.

    Reason

    Cassette may leak during set up or during peritoneal dialysis treatment

    Action

    Fresenius Medical Care sent a Urgent Recall letter dated June 11, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their stock immediately and discontinue use and return product. Please contact your Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions to return the product.

    Distribution

    Nationwide Distribution

    Quantity

    5480 units