BEUDAMED
    FDA Enforcement Class II Ongoing

    EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only

    Recall: Z-0635-2024 · Reported January 10, 2024

    Enforcement

    Recall Number
    Z-0635-2024
    Event ID
    93550
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Natus Medical Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 10, 2024
    Initiation Date
    November 28, 2023
    Classification Date
    January 4, 2024
    Address
    5955 Pacific Center Blvd, N/A, San Diego, CA, 92121-4309, United States

    Description

    EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only

    Reason

    Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

    Code Info

    UDI: 00382830050555/ Lot #: 1FX0004588937 1FX0004588938 1FX0004588939 1FX0004663828 1FX0004663825 1FX0004663826 1FX0004663824 1FX0004663827 1FX0004857869 1FX0004857871 1FX0004663829 1FX0004663830 1FX0004857870 1FX0004763454 1FX0004833126 1FX0004833140 1FX0004833139 1FX0004857872 1FX0004857873 1FX0004833127 1FX0004833136 1FX0004763455 1FX0004763460 1FX0004763463 1FX0004763464 1FX0004763462 1FX0004763461 1FX0004763459 1FX0004857877 1FX0004857875 1FX0004857874 1FX0004763457 1FX0004857876 1FX0004763465 1FX0004763456 1FX0004833141 1FX0004763458 1FX0004857882 1FX0004857881 1FX0004857880 1FX0004857878 1FX0004857879 1FX0004857886 1FX0004857884 1FX0004857885 1FX0004857887 1FX0004857888 1FX0004857886 1FX0004857883 1FX0004857889

    Distribution

    US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV.

    Quantity

    3,336 units