BEUDAMED
    FDA Recall Terminated

    HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

    Recall: Z-3041-2017 · Initiated July 5, 2017

    Recall

    Recall Number
    Z-3041-2017
    Event Number
    77711
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    July 5, 2017
    Terminated
    October 5, 2020
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

    Reason

    Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their Peritoneal Dialysis (PD) therapy, damaging the cassettes for the HomeChoice or HomeChoice PRO cyclers. If damaged cassettes are used, the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region and the cycler may deliver air into the patient.

    Action

    The firm notified their consignees by letter on 07/05/2017 of the potential for damaging the disposable set if tools are used to open the packaging and directing them to only open the packaging by hand by letter.

    Distribution

    Worldwide Distribution

    Quantity

    23732 units