Events

Recall of Smiths Medical Epidural Minipack Systems

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Smiths Medical International Ltd (UK).

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
    15637
  • Event Initiated Date
    2013-11-13
  • 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 wording in the current ifu states : "if resistance is felt upon withdrawal, consult current medical literature for specific techniques". this is to be replaced by : "if resistance is felt or if the catheter stretches excessively on withdrawal, cease removal. never exert excessive force as this may compromise the integrity of the catheter. if clinically appropriate, reposition the patient (flex or extend, sit up or lay down) and slowly withdraw the catheter. if further resistance, repeat step and/or allow the patient to relax for several minutes/hours and attempt to remove later. if unable to remove, consult anesthetist. after removal, examine the catheter to ensure that the entire catheter with tip is intact. should the tip not be intact, consult the anesthetist".
  • Action
    Instructions for use to be updated

Device

Smiths Medical Epidural Minipack Systems

Manufacturer

Smiths Medical International Ltd (UK)