BEUDAMED
    FDA Enforcement Class I Terminated

    Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system

    Recall: Z-2717-2020 · Reported August 12, 2020

    Enforcement

    Recall Number
    Z-2717-2020
    Event ID
    85691
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 12, 2020
    Initiation Date
    June 30, 2020
    Classification Date
    August 6, 2020
    Termination Date
    April 22, 2024
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system

    Reason

    Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

    Code Info

    During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers. US and OUS serial numbers:

    Distribution

    Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH

    Quantity

    824277