Events

Recall of GEMSTAR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HOSPIRA HEALTHCARE CORPORATION.

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
    141483
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-14
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
    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
  • Reason
    A lithium battery that is not user accessible is used to power the memory that stores the current infusion settings and the event history logs when the pump is turned off. if the battery's voltage level drops below 2.4 volts an 11/004 error will be displayed and the device will not be able to be used resulting in a possible delay/interruption in therapy.

Device

GEMSTAR
  • Model / Serial
    Model Catalog: 13150 (Lot serial: All Serial Numbers); Model Catalog: 13087 (Lot serial: All Serial Numbers); Model Catalog: 13088 (Lot serial: All Serial Numbers); Model Catalog: 13000 (Lot serial: All Serial Numbers)
  • Product Description
    Gemstar Pumps
  • Manufacturer
    HOSPIRA HEALTHCARE CORPORATION

Manufacturer

HOSPIRA HEALTHCARE CORPORATION
  • Manufacturer Address
    SAINT-LAURENT
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    HC