Events

Recall of Device Recall Hospira

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hospira Inc., A Pfizer Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74903
  • Event Risk Class
    Class 2
  • Event Number
    Z-2790-2016
  • Event Initiated Date
    2016-07-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148718
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • 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.

Device

Device Recall Hospira
  • Model / Serial
    List Numbers 16037-64-02 and 16037-64-03
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including ND, TX, MI, MN, WI, IA, ME, HI, PA, MA, NJ, NY, CT, and Internationally to Canada.
  • Product 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.
  • Manufacturer
    Hospira Inc., A Pfizer Company

Manufacturer

Hospira Inc., A Pfizer Company
  • Manufacturer Address
    Hospira Inc., A Pfizer Company, 275 N Field Dr, Lake Forest IL 60045-2579
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    USFDA