Events

Recall of Device Recall Hospira Phoenix Infusion System with MedNet Software, One Channel Infusion System

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

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
    52523
  • Event Risk Class
    Class 2
  • Event Number
    Z-1816-2009
  • Event Initiated Date
    2009-03-31
  • Event Date Posted
    2009-08-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83445
  • 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
    Potential delay/underinfusion of critical therapy-- devices experience increased frequency of alarms that result in temporary pump stoppage.
  • Action
    Hospira, Inc. issued an "Urgent: Device Field Correction" dated March 31, 2009 via Federal Express to Healthcare Professionals and Valued Hospira Customers. Consignees were informed of the affected devices and will be contacted by a Hospira representative to arrange necessary device upgrades. For further questions, contact Hospira Global Product Safety and Complaints at 1-800-441-4100.

Device

Device Recall Hospira Phoenix Infusion System with MedNet Software, One Channel Infusion System
  • Model / Serial
    List number 16027-04-83/84 and 87/88, software versions 2.1 and 3.0 only.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 59 consignees to all 50 States.
  • Product Description
    Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Manufacturer Address
    Hospira Inc, 755 Jarvis Dr, Morgan Hill CA 95037-2810
  • Source
    USFDA