BEUDAMED
    FDA Enforcement Class I Terminated

    CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress

    Recall: Z-1474-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1474-2020
    Event ID
    85033
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    CME America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2020
    Initiation Date
    January 7, 2020
    Classification Date
    March 18, 2020
    Termination Date
    April 14, 2022
    Address
    14998 W 6th Ave Ste 830, Golden, CO, 80401-5025, United States

    Description

    CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress

    Reason

    Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected drug delivery when infusing at high flow rates (greater-than 500 mL/h)

    Code Info

    All serial numbers

    Distribution

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

    Quantity

    30,596 pumps