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..

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
    69505
  • Event Risk Class
    Class 2
  • Event Number
    Z-0421-2015
  • Event Initiated Date
    2013-03-19
  • Event Date Posted
    2014-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130773
  • 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
    Some patients are obtaining access to the dosage reset codes required to change the settings on gemstar infusion pumps and are subsequently changing the infusion rate set by their doctors. patients are obtaining access to these codes via website sponsors by downloading the gemstar user/service manual featured on the sponsors' websites. the gemstar user/service manual should be removed from these w.
  • Action
    Hospira sent a letters dated March 19, 2013 to Internet website sponsors to request removal of the GemStar User/Service Manual from their websites as soon as possible. The Internet website sponsors were requested to return a confirmation form after removing the GemStar User Service Manual from their site. For questions call 224-212-2891.

Device

Device Recall Hospira
  • Model / Serial
    List Numbers: 13000, 13100, 13150; Serial Numbers: All Serial Numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US: Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Croatia, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Icelanofd, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, New Zealand, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom
  • Product Description
    GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. || Product Usage || The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours. || .
  • 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