Events

Recall of Medline Paediatric Cardiac Bypass procedure packs

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Medline Assembly Australia Pty 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
    14694
  • Event Initiated Date
    2013-05-24
  • 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: Medline International New Zealand Limited, 14 George Bourke Drive, Mt Wellington, Auckland 1060
  • Reason
    The affected procedure packs include a bd 50ml luer lok syringe which is currently subject to a recall action. (ref #14513), the syringes have been manufactured with a new design stopper which may exhibit higher plunger forces and result in false occlusion alarms being triggered.
  • Action
    Manufacturer to issue advice regarding use

Device

Medline Paediatric Cardiac Bypass procedure packs

Manufacturer

Medline Assembly Australia Pty Ltd