BEUDAMED
    FDA Enforcement Class I Terminated

    BodyGuard BodySet, REF: A120-160SAS

    Recall: Z-2553-2020 · Reported July 22, 2020

    Enforcement

    Recall Number
    Z-2553-2020
    Event ID
    85650
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    CME America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2020
    Initiation Date
    June 16, 2020
    Classification Date
    July 15, 2020
    Termination Date
    May 9, 2022
    Address
    14998 W 6th Ave Ste 830, N/A, Golden, CO, 80401-5025, United States

    Description

    BodyGuard BodySet, REF: A120-160SAS

    Reason

    Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

    Code Info

    All lots within expiry date

    Distribution

    U.S: CA, IN, LA, MO, FL, IL, ME, MN, CO, VA, OK, NE, GA, AL, KY, IA, MS, ID, TX, SC, OH, SD, NV, MI, WY, NC, PA, TN, KS, NJ, OR, AR, NM, MA, NY, DC, RI, MD, WA, WI, AZ, NH, UT, HI, AK, MT, ND, VT, CT. OUS (Foreign): Canada, UK

    Quantity

    3250