Events

Recall of GemStar Infusion System

According to Valvira - National Supervisory Authority for Welfare and Health (via FOI), this recall involved a device in Finland 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
    2013-0536
  • Date
    2013-04-02
  • Event Country
    Finland
  • Event Source
    VNSAWH
  • Notes / Alerts
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
    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
    Source: NCAR
  • Reason
    Device failure / feature after commissioning - other.

Device

GemStar Infusion System

Manufacturer

Hospira Inc.
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    VNSAWH