BEUDAMED
    FDA Recall Terminated

    Automated peritoneal dialysis (APD) cycler

    Recall: Z-1565-2016 · Initiated February 16, 2016

    Recall

    Recall Number
    Z-1565-2016
    Event Number
    73435
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 16, 2016
    Terminated
    December 23, 2016
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    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

    Action

    An Urgent Device Correction communication was sent to the one affected customer via U.S.P.S., first class mail on 02/11/2016. A Clinician Guide Addendum was created to instruct clinicians of the extra 200 mL of PD solution required to prime the patient line and for air purge operations. This Addendum was provided as an attachment to the Urgent Device Correction communication letter.

    Distribution

    US Consignee: NY ***Foreign Consignee: Ecuador

    Quantity

    10 units