BEUDAMED
    FDA Enforcement Class II Terminated

    BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.

    Recall: Z-1886-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1886-2020
    Event ID
    85206
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CME America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2020
    Initiation Date
    January 14, 2020
    Classification Date
    May 4, 2020
    Termination Date
    May 27, 2021
    Address
    14998 W 6th Ave Ste 830, N/A, Golden, CO, 80401-5025, United States

    Description

    BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.

    Reason

    The filter installed onto the tube set may have the incorrect pore size.

    Code Info

    Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829 BodyGuard Microset 10818666020006 A120-112XSFK 16201

    Distribution

    US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.

    Quantity

    5,800 infusion sets from lot 90829 and 24,500 from lot 16201