BEUDAMED
    FDA Recall Terminated

    Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)

    Recall: Z-0738-2008 · Initiated December 3, 2007

    Recall

    Recall Number
    Z-0738-2008
    Event Number
    46292
    Firm
    Fresenius Medical Care North America
    FEI Number
    3001451489
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 3, 2007
    Posted
    February 1, 2008
    Terminated
    February 8, 2008
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)

    Reason

    Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.

    Action

    Consignees were notified by telephone and certified letter , Urgent Device Recall, on 12/03/2007. They were told to discontinue use and to return all unused affected dialyzers to Fresenius.

    Distribution

    Nationwide including the states of AZ, CA, HI, IA, ID, IL, IN, KS, KY, MI, MN, MO, NE, NV, NY, OH, OR, PA, WA, and WI.

    Quantity

    2,791 cases (33,492 dialyzers)