Events

Recall of STERRAD 100NX and STERRAD 200 Sterilisation Systems

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-2013-RN-00298-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00298-1
  • 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
    The manufacturer (asp) has determined that these systems may emit an odour or smell into the surrounding environment that is not typical to normal operating conditions. although odours/ smells occur environmentally throughout the healthcare environment, odours/smells may also be related to normal breakdown of the oil used in the steriliser vacuum pump on the sterrad 100nx and/or sterrad 200.
  • Action
    The manufacturer is providing users with work around instructions while it continues to investigate the root cause of the problem.

Device

STERRAD 100NX and STERRAD 200 Sterilisation Systems
  • Model / Serial
    STERRAD 100NX and STERRAD 200 Sterilisation SystemsProduct Code: 10104 & 10200 All units shipped to dateARTG Number: 123603
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd