BEUDAMED
    FDA Enforcement Class II Terminated

    Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.

    Recall: Z-0799-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0799-2013
    Event ID
    64175
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 20, 2013
    Initiation Date
    October 12, 2012
    Classification Date
    February 11, 2013
    Termination Date
    December 30, 2020
    Address
    920 Winter St, Waltham, MA, 02451-1521, United States

    Description

    Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.

    Reason

    There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.

    Code Info

    Lot 12BR08009

    Distribution

    Nationwide Distribution.

    Quantity

    560 cases, totaling 5590 units