BEUDAMED
    FDA Recall 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 · Initiated July 28, 2016

    Recall

    Recall Number
    Z-2790-2016
    Event Number
    74903
    Firm
    Hospira Inc., A Pfizer Company
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 28, 2016
    Terminated
    November 2, 2018
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    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.

    Action

    Hospira sent an Urgent Medical Device Correction letter dated July 28, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter provided instructions for step-by-step process to mitigate the issue. Customers with questions were instructed to contact Hospira Global Complaint Management at 1-800-441-4100 or Hospira Technical Service Center at 1-800-241-4002, option 4.

    Distribution

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

    Quantity

    20