BEUDAMED
    FDA Recall 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 · Initiated April 16, 2014

    Recall

    Recall Number
    Z-1643-2014
    Event Number
    67996
    Firm
    Gambro Renal Products, Incorporated
    FEI Number
    1713683
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Storage
    Initiated
    April 16, 2014
    Posted
    May 21, 2014
    Terminated
    December 8, 2015
    Address
    14143 Denver West Pkwy, Lakewood, CO, 80401-3266

    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.

    Action

    The recall was initiated by an Urgent: Medical Device Recall letter delivered by UPS Overnight Delivery on April 16, 2014. The letter identified the affected product and reason for the recall. The firm is asking customers to remove and quarantine any remaining affected product from their inventory for collection and replacement. Customers are to also complete and return the Customer Reply Form to the Gambro Regulatory Affairs Department. Customers with affected product are to contact Gambro Customer Support or their Gambro representative to return the product. Questions should be directed to Customer Support at 1-800-651-2623.

    Distribution

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

    Quantity

    2,461,824 units total