Events

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
    14365
  • Event Initiated Date
    2013-04-03
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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
    The proximal and distal pressure sensor calibration can drift resulting in the pump failing the proximal or distal occlusion operational test, as described in the gemstar technical service manual (tsm). a pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
  • Action
    Instructions for use to be updated

Device

Hospira GemStar Infusion pump

Manufacturer

Hospira Inc
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    NZMMDSA