Events

Recall of Bowl Surgical Drape

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by De Fries Industries 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-00709-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00709-3
  • 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
    There may be presence of foreign body particles on the drape material inside the packaging.
  • Action
    Quarantine and return affected stock to De Fries Industries for replacement or credit note.

Device

Bowl Surgical Drape
  • Model / Serial
    Bowl Surgical DrapeCatalogue Number: DEF2939Batch Numbers: 11-354,12-035, 12-048, 12-076Order Code: DEF2939ARTG Number: 158307
  • Manufacturer
    De Fries Industries Pty Ltd

Manufacturer

De Fries Industries Pty Ltd