Events

Recall of Device Recall Hospira brand Symbiq OneChannel Infuser

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
    56462
  • Event Risk Class
    Class 1
  • Event Number
    Z-0127-2011
  • Event Initiated Date
    2010-02-22
  • Event Date Posted
    2010-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93731
  • 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 has identified motor encoder failures in the symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy.
  • Action
    Hospira issued a Recall Notification letter dated October 4, 2010, updating the Urgent Device Field Correction letter dated February 22, 2010, ideentifying the affected products, the issue prompting the recall, and actions to be taken by customers. Customers are to examine their inventory to determine if they have any of the affected products, and recommended to remove them from service in critical care areas, and contact Hospira to schedule removal and replacement of the motor. Replace affected devices with a loaner or corrected back-up pump if available. Custoemrs can contacvtd Hospira Global Product Safety and Complaints at 1-800-441-4100, and Technical Support Operations at 1-800-241-4002.

Device

Device Recall Hospira brand Symbiq OneChannel Infuser
  • Model / Serial
    All units of these List Numbers.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA and the coutnries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.
  • Product Description
    Hospira brand Symbiq One-Channel Infuser || LIST No. 16026 Symbiq One-Channel Infuser, || List Number Configurations: || 16026-04-01/03/04,51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90, || 16026-13-25/26, 53/54, || Distributed 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