Events

Recall of STERRAD 100NX Cassette (Used to provide hydrogen peroxide sterilant used in the STERRAD NX 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-2013-RN-00811-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00811-1
  • 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
    Sterrad 100nx system cassettes are designed with a leak indicator on the outer package to provide a visual colour indication in the event hydrogen peroxide has leaked from the cassettes. the manufacturer has determined it does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the sterrad 100nx system cassette's 15 month shelf life.
  • Action
    Johnson & Johnson Medical (JJM) is requesting end users to wear additional safety equipment (protective gloves and eye wear) in the event of handling product with an expired leak indicator as a precautionary measure for devices with an expiration date prior to 1 November 2014. End users are also requested to check for signs of indicator colour change or liquid leakage prior to opening the package. If the white indicator has turned red or a liquid leak is observed, customers are asked to dispose of the cassette immediately. Any indication of leakage should also be notified to JJM.

Device

STERRAD 100NX Cassette (Used to provide hydrogen peroxide sterilant used in the STERRAD NX Steril...
  • Model / Serial
    STERRAD 100NX Cassette (Used to provide hydrogen peroxide sterilant used in the STERRAD NX Steriliser)Part Number: 10144Expiration dates before November 1, 2014
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd