BEUDAMED
    FDA Recall 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 · Initiated December 16, 2016

    Recall

    Recall Number
    Z-1056-2017
    Event Number
    75998
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 16, 2016
    Posted
    January 19, 2017
    Terminated
    August 24, 2017
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    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

    Action

    An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail.

    Distribution

    US only

    Quantity

    8640 eaches