BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1031-2015 · Initiated October 21, 2014

    Recall

    Recall Number
    Z-1031-2015
    Event Number
    70232
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 21, 2014
    Posted
    January 29, 2015
    Terminated
    September 1, 2015
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    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.

    Action

    An Urgent Device Correction notification was sent to consignees on October 31, 2014. Within the notification, Baxter Healthcare asked customers to do the following: 1) Contact Baxter Technical Services to arrange for the exchange (swap) of any affected HomeChoice PRO Automated PD System devices. 2) Complete the attached customer reply form and return it to Baxter by either fax or scanned e-mail. For general questions regarding this communication, contact The Center for One Baxter at 900-422-9837, Monday through Friday between the hours of 8:00 AM and 5:00 PM Central Time.

    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