BEUDAMED
    FDA Enforcement Class III Terminated

    Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

    Recall: Z-0291-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0291-2016
    Event ID
    71818
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2015
    Initiation Date
    June 29, 2015
    Classification Date
    November 17, 2015
    Termination Date
    January 24, 2017
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

    Reason

    Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. May delay treatment if changing to a different system.

    Code Info

    All HomeChoice and HomeChoice PRO devices. All LOT numbers and Serial number for Product Codes 5C4471, 5C4471R, 5C8310 and 5C8310R. Dates Distributed: 1994 to present Quantity Distributed: All

    Distribution

    Nationwide Distribution, District of Columbia, and Puerto Rico.

    Quantity

    29355