Events

Recall of STERRAD CYCLESURE 24 Biological Indicators within Validation Kits - (sterilisation process indicator) Biological Indicators within Validation Kits:STERRAD NX Validation Kit – STERRAD 100NX Validation Kit – STERRAD 100S/50 Validation Kit

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-00673-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00673-3
  • 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, asp, has determined that it does not have adequate data to support the entire duration of the product’s labelled shelf-life. as a result, the shelf life of sterrad cyclesure 24 biological indicator (bi) will be reduced by 9 months from the current expiry date on the product label.
  • Action
    J&J; is asking customers to quarantine the affected lots that exceed the newly determined expiration date and return it to J&J.; Until the replacement stock is available, customers may continue to use the current inventory if it still has more than 9 month’s shelf life remaining. Product with labelled expiry date of May 2013 or later can be used.

Device

STERRAD CYCLESURE 24 Biological Indicators within Validation Kits - (sterilisation process indica...
  • Model / Serial
    STERRAD CYCLESURE 24 Biological Indicators within Validation Kits - Product codes: 14324, 20253, 20228, 20232 (sterilisation process indicator)Biological Indicators within Validation Kits:STERRAD NX Validation Kit – Product code 20253STERRAD 100NX Validation Kit – Product code 20228STERRAD 100S/50 Validation Kit – Product code 20232Multiple lot numbersARTG number: 134121
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd