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
    19334
  • Event Initiated Date
    2015-12-04
  • 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
    Under specfic circumstances the sapphire pump may not detect an occlusion., the resultant potential delay in therapy may happen if all of the following conditions occur:, 1. the clamp is left closed at the "start" of the treatment, and, 2. the treatment is set at epidural mode, and, 3. the programmed treatment is set to "bolus only" i.E the basal rate =0.
  • Action
    Software to be upgraded

Device

Hospira Sapphire Infusion Pump
  • Model / Serial
    Model: , Affected: Software version 11.00 or lower
  • Manufacturer
    Q Core Medical Ltd

Manufacturer

Q Core Medical Ltd