Events

Recall of STERRAD 100S Cassettes

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-2014-RN-00281-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-03-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00281-1
  • 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
    The manufacturer, asp has identified that the misaligned barcodes may cause the cassette to be slightly out of position. the barcode on the sterrad 100s cassette is used to register the position of the cassette in the sterilizer. an out of position cassette may cause the first cycle on that cassette to cancel, or in extreme cases may cause the injection needles used to remove hydrogen peroxide from the sterrad 100s cassette to be damaged. the position of the barcode on the affected lots is variable and the probability of resulting damage to the injection needles is low.
  • Action
    Johnson & Johnson Medical is advising users to continue to use current stock until a replacement product has been provided. Affected stock can be returned to Johnson & Johnson Medical once unaffected stock has been received. This action has been closed-out on 12/02/2016.

Device

STERRAD 100S Cassettes
  • Model / Serial
    STERRAD 100S CassettesProduct Code: 10113Lot Numbers; 13I038, 13I046, 13I071, 13I072, 13I077, 13I078, 13I083, 13I084, 13I090, 13I121, 13K003, 13K074, 13K105, 13L021, 14A030 & 14A031ARTG Number: 123602
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd