BEUDAMED
    FDA Enforcement Class II Terminated

    AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.

    Recall: Z-0849-2019 · Reported February 27, 2019

    Enforcement

    Recall Number
    Z-0849-2019
    Event ID
    81738
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2019
    Initiation Date
    December 11, 2018
    Classification Date
    February 20, 2019
    Termination Date
    February 12, 2021
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.

    Reason

    Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy

    Code Info

    Product code 5C9320. All serial numbers are affected for devices distributed from 02/11/2016 through 11/27/2018.

    Distribution

    Worldwide Distribution - US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to Canada and Japan.

    Quantity

    7,688 devices