BEUDAMED
    FDA Enforcement Class II Terminated

    Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

    Recall: Z-1643-2014 · Reported May 28, 2014

    Enforcement

    Recall Number
    Z-1643-2014
    Event ID
    67996
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gambro Renal Products, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2014
    Initiation Date
    April 16, 2014
    Classification Date
    May 21, 2014
    Termination Date
    December 8, 2015
    Address
    14143 Denver West Pkwy, N/A, Lakewood, CO, 80401-3266, United States

    Description

    Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

    Reason

    The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

    Code Info

    Lot Numbers: C413124101, C413124301, C413124501, C413124601, C413124701, C413124801, C413124901, C413125001, C413125101, C413125201, C413125301, C413125401, C413125501, C413125601, C413125701, C413125801, C413125901, C413126001, C413126101, C413126201, C413126301, C413126401, C413126501, C413126601, C413126701, C413126801, C413126901, C413127001, C413127101, C413127201, C413127301, C413127401, C413127501, C413127601, C413127701, C413127801, C413127901, C413128001, C413128101, C413128201, C413128401, C413128501, C413128601, C413128701, C413128801, C413128901, C413129001, C413129101, C413129201, C413129301, C413129401, C413129501, C413129601, C414100101, C414100601, C414101001, C414101201, C414101401, C414102101, C414102301, C414103001, C414103401, C414103501, and C414103801.

    Distribution

    Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.

    Quantity

    2,461,824 units total