BEUDAMED
    FDA Enforcement Class II Terminated

    APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.

    Recall: Z-1056-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1056-2017
    Event ID
    75998
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2017
    Initiation Date
    December 16, 2016
    Classification Date
    January 19, 2017
    Termination Date
    August 24, 2017
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.

    Reason

    Customer complaints received for the presence of leaks

    Code Info

    H16F16088

    Distribution

    US only

    Quantity

    8640 eaches