Events

Field Safety Notices about ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Hospira.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-05-14
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Hospira would like to remind you of the importance of performing the pre-use checks prior to the use of the gemstar infusion pump. hospira has received reports of gemstar infusion pumps failing to power on, or powering off during use, because the battery door was broken or damaged. hospira would like to remind users to inspect the condition of the battery door per the instructions in the system operating manual (som) before use of the device. .

Device

ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS
  • Model / Serial
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    AMPMDRS