Recall of Hospira GemStar Infusion pump

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    15684
  • Event Initiated Date
    2013-11-22
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
    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
    Recalling Organisation: Hospira NZ Ltd, 58 Richard Pearse Drive, Airport Oaks, Mangere, Auckland 2022
  • Reason
    Hospira has become aware that some healthcare professionals may not have appropriately secured their gemstar infusion pumps via the keypad lock code. reports indicate that patients or unauthorized carers have been able to locate the default keypad lock code for gemstar infusion pumps through internet searches in order to tamper with programmed infusion parameters. one of the reports resulted in a serious injury, hospira have received no reports relating to this issue in new zealand or australia.
  • Action
    Instructions for use to be updated

Device

  • Model / Serial
    Model: List numbers: 13000, 13087, 13088, 13150, 13100, Affected: All serial numbers
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    NZMMDSA