Events

Recall of A&E Aorta Punch

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by A & E Medical Corporation.

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
    22144
  • Event Initiated Date
    2017-10-24
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    There is potential packaging damage to have occurred during transportation, resulting in a loss of sterility. recent testing has identified certain shipping configurations which may cause damage to the sterile barrier pouch if the surgical punches experience excessive movement from multiple drops during transport.
  • Action
    Product to be returned to supplier

Device

A&E Aorta Punch

Manufacturer

A & E Medical Corporation