Events

Recall of Sterrad 100NX system (Sterilisation system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical 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
    RC-2016-RN-00996-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-07-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00996-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Johnson & johnson medical (jjm) is advising that the sterrad 100nx system requires a ctick label (rfid) be applied to comply with the australian communications and media authority (acma) spectrum licensing and ctick requirements.
  • Action
    Johnson & Johnson Medical will be attending all sites to place the required label on the affected devices. This action has been closed-out on 13/07/2017.

Device

Sterrad 100NX system (Sterilisation system)
  • Model / Serial
    Sterrad 100NX system (Sterilisation system)Part Numbers: 10104, 10104002, 10104003, 10104004ARTG Number: 123603
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd