Events

Recall of GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a GemStar battery pack)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hospira Pty Limited.

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
    RC-2012-RN-00708-3
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-07-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00708-3
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
    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
    This is an update to hospira’s previous safety alert notice (tga ref # rc-2011-rn-00812-3) concerning the gemstar docking station. at that time, hospira had received reports from customers of sparking, smoking, charring and electrical shock when using the gemstar docking station. hospira’s investigation concluded that the primary root cause was related to the potential for fluid ingress into the docking station. the design improvements have now been finalised and hospira is replacing all existing docking stations with the new design.
  • Action
    Customers to advise Sponsor of the number of docking stations held and they will be replaced with the newly designed units.

Device

GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a G...
  • Model / Serial
    GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a GemStar battery pack)List Numbers: 13075.1 and 13075.3 (2003 - 2006); 13075-24-03, 13075-24-05 & 13075-24-07 (2006 - 2011)ARTG Number: 138118
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DHTGA