BEUDAMED
    FDA Enforcement Class II Terminated

    BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP

    Recall: Z-1126-2015 · Reported February 25, 2015

    Enforcement

    Recall Number
    Z-1126-2015
    Event ID
    70294
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CME America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 25, 2015
    Initiation Date
    January 16, 2015
    Classification Date
    February 19, 2015
    Termination Date
    March 31, 2017
    Address
    14998 W 6th Ave, Golden, CO, 80401-6587, United States

    Description

    BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP

    Reason

    CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.

    Code Info

    All product with USA36A4.4 version of software affected

    Distribution

    Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.

    Quantity

    3,186