BEUDAMED
    FDA Enforcement Class II Terminated

    Automated peritoneal dialysis (APD) cycler

    Recall: Z-1565-2016 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1565-2016
    Event ID
    73435
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2016
    Initiation Date
    February 16, 2016
    Classification Date
    April 25, 2016
    Termination Date
    December 23, 2016
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Automated peritoneal dialysis (APD) cycler

    Reason

    Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot

    Code Info

    N/A

    Distribution

    US Consignee: NY ***Foreign Consignee: Ecuador

    Quantity

    10 units