Events

Recall of STERRAD Boosters and Adaptors (used in STERRAD NX steriliser and contains hydrogen peroxide sterilant)

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-01217-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01217-1
  • 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
    It has been determined that the instructions for use (ifu) for the sterrad booster and sterrad adaptor include incorrect directions for when a sterrad booster and adapter i, ii and iii is required to be used. it has also been determined that the current procedures for fitting a sterrad booster do not adequately mitigate the risk of improper seal between the scope and the booster or inadequate cleaning of the adaptor/scope interface.
  • Action
    J&J; Medical is advising customers of the correct procedure to follow and providing the updated instructions for use (IFU) to ensure the devices are properly sterilised. A new checklist has also been developed to provide additional verification of the proper use of the STERRAD booster/adapter before and after the STERRAD cycle. This action has been closed-out on 10/02/2016.

Device

STERRAD Boosters and Adaptors (used in STERRAD NX steriliser and contains hydrogen peroxide steri...
  • Model / Serial
    STERRAD Boosters and Adaptors (used in STERRAD NX steriliser and contains hydrogen peroxide sterilant)ARTG Number: 123602
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd