BEUDAMED
    FDA Enforcement Class II Terminated

    Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T

    Recall: Z-1693-2013 · Reported July 17, 2013

    Enforcement

    Recall Number
    Z-1693-2013
    Event ID
    65090
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2013
    Initiation Date
    May 24, 2013
    Classification Date
    July 11, 2013
    Termination Date
    October 7, 2019
    Address
    920 Winter St, N/A, Waltham, MA, 02451-1521, United States

    Description

    Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T

    Reason

    Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)

    Code Info

    Part Number: 640919

    Distribution

    Nationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA.

    Quantity

    725 units