BEUDAMED
    FDA Recall Terminated

    Polyflux Revaclear Dialyzer, Model Number 110633. 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-0489-2015 · Initiated November 5, 2014

    Recall

    Recall Number
    Z-0489-2015
    Event Number
    69786
    Firm
    Gambro Renal Products Inc
    FEI Number
    3006552611
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 5, 2014
    Posted
    December 1, 2014
    Terminated
    May 20, 2015
    Address
    1101 Jeter Ave, Opelika, AL, 36801-3885

    Description

    Polyflux Revaclear Dialyzer, Model Number 110633. 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.

    Action

    Recall letter was sent via UPS delivery next day to US customers on November 5th, 2014. Product that is returned will be quarantined at the distribution centers.

    Distribution

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

    Quantity

    20 million dialyzers