Events

Recall of STERRAD 100S System Cassettes (To provide the hydrogen peroxide sterilant used in the STERRAD Steriliser)

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-2012-RN-00697-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00697-3
  • 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 has discovered that printed information on the cassette results in the steriliser being unable to properly read the barcode. during the automated process used to print information on sterrad 100s system cassettes, an additional thirteenth (13th) bar was added to the barcode resulting in an unusable cassette. because the sterrad 100s system is designed to accept only properly coded cassettes, the sterrad 100s will reject all incorrect cassettes and display an error message: “incorrect cassette type”.
  • Action
    Quarantine and return affected product to Johnson & Johnson Medical.

Device

STERRAD 100S System Cassettes (To provide the hydrogen peroxide sterilant used in the STERRAD Ste...
  • Model / Serial
    STERRAD 100S System Cassettes (To provide the hydrogen peroxide sterilant used in the STERRAD Steriliser)Product Number: 10113Lot Number: 12A070ARTG Number: 123602
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd