Events

Recall of Hospira GemStar Docking station

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
    15721
  • Event Initiated Date
    2013-11-29
  • 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
    Hospira inc. has become aware of two situations that may occur when using the gemstar docking station list numbers 13075-xx-07 and 13075-xx-09 in conjunction with the gemstar infusion pump., when the docking station is used in conjunction with a gemstar phase 3 infusion pump (list numbers 13000-xx, 13100-xx or 13150-xx), the potential exists for the pump to fail to power up while connected to the docking station., when a gemstar phase 4 infusion pump (list numbers 13086-xx, 13087-xx or 13088-xx) is used in conjunction with both a docking station and an external battery pack accessory (list 13073-xx), there exists a possibility that the gemstar pump will display error code 11/003 indicating excessive input voltage from the external sources. the 11/003 error code will stop infusion if the error occurs when an infusion is in process.
  • Action
    Instructions for use to be updated

Device

Hospira GemStar Docking station

Manufacturer

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