BEUDAMED
    FDA Enforcement Class II Terminated

    HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.

    Recall: Z-1031-2015 · Reported February 4, 2015

    Enforcement

    Recall Number
    Z-1031-2015
    Event ID
    70232
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2015
    Initiation Date
    October 21, 2014
    Classification Date
    January 29, 2015
    Termination Date
    September 1, 2015
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.

    Reason

    The keypad buttons on HomeChoice devices may be activated without the operator pressing them.

    Code Info

    all codes distributed between 4/15/2014 and 6/11/2014

    Distribution

    AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and District of Columbia

    Quantity

    200