BEUDAMED
    FDA Enforcement Class II Terminated

    GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.

    Recall: Z-0370-2017 · Reported November 16, 2016

    Enforcement

    Recall Number
    Z-0370-2017
    Event ID
    75414
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 16, 2016
    Initiation Date
    October 12, 2016
    Classification Date
    November 8, 2016
    Termination Date
    August 19, 2017
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.

    Reason

    Potential presence of particulate matter on the blood side of the dialyzer

    Code Info

    C416201601

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.

    Quantity

    22,656 units