Events

Recall of STERRAD 100S, STERRAD 50 and STERRAD NX 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-01355-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01355-1
  • 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
    Asp has received customer complaints by healthcare workers reporting odours/smells potentially emanating from the sterrad systems. odours/smells may also be related to normal breakdown of the oil used in the steriliser vacuum pump on the sterrad 100s ,sterrad 50 and/or sterrad nx . the reported odours/smells do not impact sterility of the devices processed within the sterrad systems. asp is investigating this issue to determine the source of the odour/smell and will continue to perform planned maintenance in accordance with each system’s schedule.
  • Action
    If users observe any odours/smells, Johnson and Johnson Medical is requesting them to leave the room as a precaution and discontinue the use of STERRAD Systems until they are serviced.

Device

STERRAD 100S, STERRAD 50 and STERRAD NX Sterilisation Systems

Manufacturer

Johnson & Johnson Medical Pty Ltd