BEUDAMED
    FDA Recall Terminated

    Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404. Designed for single use acute and chronic hemodialysis.

    Recall: Z-1951-2010 · Initiated May 14, 2010

    Recall

    Recall Number
    Z-1951-2010
    Event Number
    55771
    Firm
    Fresenius Medical Care North America
    FEI Number
    3001451489
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 14, 2010
    Posted
    July 1, 2010
    Terminated
    September 13, 2011
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404. Designed for single use acute and chronic hemodialysis.

    Reason

    Hemodialyzer may leak at the header/end cap

    Action

    Fresenius Medical notified customers by telephone script beginning May 14, 2010 and follow up letter advising users to examine inventory for recalled lot, discontinue use and contact Fresenius Customer Care 1-800-325-5188 , ext. 6610 for instructions on how to return the recalled product.

    Distribution

    Nationwide Distribution

    Quantity

    34,152 units