Events

Recall of Syringe Pump

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Smiths Medical ASD 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
    22664
  • Event Initiated Date
    2018-02-27
  • 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: Smiths Medical Australasia Pty Ltd, c/o KPMG, KPMG Centre, 18 Viaduct Harbour Avenue, Auckland
  • Reason
    The manufacturer has identified that certain medfusion® syringe pump model series 3500 pumps were assembled with a barrel clamp guide that contained a ridge in the component. this ridge could potentially lead to spring slippage, resulting in the inability of the pump to recognise a syringe or the pump may misidentify the size of syringe loaded.
  • Action
    Product to be modified

Device

Syringe Pump
  • Model / Serial
    Model: Model 3500 Product Codes 3500-0600-50, 3500-0600-51, Affected:
  • Manufacturer
    Smiths Medical ASD Inc

Manufacturer

Smiths Medical ASD Inc