Events

Recall of Device Recall Hospira Inc. a Pfizer company

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
    73104
  • Event Risk Class
    Class 2
  • Event Number
    Z-0863-2016
  • Event Initiated Date
    2015-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143072
  • 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 for the symbiq pole clamp assemblies to be missing the rubber stop pad.
  • Action
    On December 22, 2015 Stericycle, Inc. sent an URGENT MEDICAL DEVICE CORRECTION notification to direct consignees of record via traceable mailing. The notification included a description of the recall, risk to health information and necessary actions to be performed by the direct account. These include: an inspection of the affected devices for missing rubber stop pad on the Symbiq pole clamp assemblies at the direct accounts.If missing rubber stop pads were discovered they were advised to contact Hospira's Advanced Knowledge Center at 1-800-241-4002, option 4, to receive a replacement pole clamp assembly or be directed to a field Service Engineer who will replace the pole clamp. Hospira ALso advised informing healthcare professionals at their institution about the issue and complete the attached reply form and return it by e-mail or fax at: 1-800-441-4100/1-800-241-4002 or at ProductComplaintsPP@hospira.com Finally customers where advised to notify FDA of any adverse events through FDA's MedWatch Adverse Event Reporting program.

Device

Device Recall Hospira Inc. a Pfizer company
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. consignees nationwide.*** Foreign consignees in: Canada.
  • Product Description
    The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion, Centers, Hospice, Sub acute facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices.
  • Manufacturer
    Hospira Inc.

Manufacturer

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