Events

Recall of Hospira Sapphire Infusion Pump

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Q Core Medical Ltd.

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
    20188
  • Event Initiated Date
    2016-06-24
  • 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.
  • Extra notes in the data
    Recalling Organisation: Hospira NZ Ltd, 58 Richard Pearse Drive, Airport Oaks, Mangere, Auckland 2022
  • Reason
    In isolated cases false "air-in-line" alarms are generated when initiating an infusion of iron sucrose at concentrations of 0.7mg/ml - 2.8 mg/ml., the epidural pumps hospira l/n 163123601/ q core p/n 15032-000-0001 use the same algorithm as in other sapphire infusion pumps models therefore the epidural pumps will be upgraded when the new software is available.
  • Action
    Software to be upgraded

Device

Hospira Sapphire Infusion Pump
  • Model / Serial
    Model: L/N 163113601, L/N 163123601, Affected:
  • Manufacturer
    Q Core Medical Ltd

Manufacturer

Q Core Medical Ltd