BEUDAMED
    FDA Enforcement Class II Terminated

    Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.

    Recall: Z-0490-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0490-2015
    Event ID
    69786
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gambro Renal Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2014
    Initiation Date
    November 5, 2014
    Classification Date
    December 1, 2014
    Termination Date
    May 20, 2015
    Address
    1101 Jeter Ave, N/A, Opelika, AL, 36801-3885, United States

    Description

    Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.

    Reason

    Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.

    Code Info

    Lot No C412207001 to C412209101, C413200101 to C413206001, C414200101 to C414206001

    Distribution

    Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.

    Quantity

    20 million dialyzers