BEUDAMED
    FDA Enforcement Class II Terminated

    AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

    Recall: Z-1245-2015 · Reported March 11, 2015

    Enforcement

    Recall Number
    Z-1245-2015
    Event ID
    70194
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2015
    Initiation Date
    April 3, 2014
    Classification Date
    March 4, 2015
    Termination Date
    July 21, 2017
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

    Reason

    Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.

    Code Info

    Product Code: 5C9310

    Distribution

    US: Nationwide in the states of (GA, MA, NC, NY, PA, WA)

    Quantity

    55 systems