BEUDAMED
    FDA Enforcement Class II Terminated

    Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.

    Recall: Z-2790-2016 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2790-2016
    Event ID
    74903
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hospira Inc., A Pfizer Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2016
    Initiation Date
    July 28, 2016
    Classification Date
    September 13, 2016
    Termination Date
    November 2, 2018
    Address
    275 N Field Dr, N/A, Lake Forest, IL, 60045-2579, United States

    Description

    Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.

    Reason

    Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units.

    Code Info

    List Numbers 16037-64-02 and 16037-64-03

    Distribution

    Worldwide Distribution - US including ND, TX, MI, MN, WI, IA, ME, HI, PA, MA, NJ, NY, CT, and Internationally to Canada.

    Quantity

    20