Events

Recall of S7XTRA Concentrate 5 Litre bottles Container: 5 litre jerry can

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Steri-7 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-2017-RN-00918-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00918-1
  • 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
    Steri-7 has identified a labelling defect where specific s7xtra ready to use has been incorrectly labelled as concentrate.
  • Action
    All S7XTRA Concentrate 5 litres bottles will need to be quarantined prior to return. Steri-7 will arrange pick up of the products in question and notify users of the next steps.

Device

S7XTRA Concentrate 5 Litre bottles Container: 5 litre jerry can
  • Model / Serial
    S7XTRA Concentrate 5 Litre bottles Container: 5 litre jerry canBatch Number: A010515Expiry Date: 04/2018 SKU: S7CON-5LTR ARTG Number: 232011
  • Manufacturer
    Steri-7 Pty Ltd

Manufacturer

Steri-7 Pty Ltd
  • Source
    DHTGA