BEUDAMED
    FDA Enforcement Class II Terminated

    The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).

    Recall: Z-2088-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2088-2021
    Event ID
    87998
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 28, 2021
    Initiation Date
    April 28, 2021
    Classification Date
    July 16, 2021
    Termination Date
    August 8, 2022
    Address
    920 Winter St Bld 950, N/A, Waltham, MA, 02451-1521, United States

    Description

    The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).

    Reason

    Exposed to freezing temperatures due to refrigerated truck malfunctions

    Code Info

    Lot Number: 20LR08111 UDI: (01)00840861100811

    Distribution

    US Distribution to: TX only

    Quantity

    5 cases