BEUDAMED
    FDA Enforcement Class I Terminated

    BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.

    Recall: Z-1442-2020 · Reported March 18, 2020

    Enforcement

    Recall Number
    Z-1442-2020
    Event ID
    84985
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    CME America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2020
    Initiation Date
    September 16, 2019
    Classification Date
    March 10, 2020
    Termination Date
    April 13, 2022
    Address
    14998 W 6th Ave Ste 830, Golden, CO, 80401-5025, United States

    Description

    BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.

    Reason

    When using a specific tubing set with infusion pump system, may result in under deliver of fluids.

    Code Info

    Catalog Number: A120-003XYVA UDI: 00818666020146 Lot Numbers: 10636 10653 12117 12836 13156 13279 13656 13978 14057 14188 14545 14790 14966 15073 19486 19490 19492 19834 16173 14966 15073 15277 15434 15802

    Distribution

    US: CA, OH, PA, and TX OUS: Canada

    Quantity

    69400 infusion sets