Events

Recall of Debriflo Ultrasonic Wound Irrigation Hand-piece

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Debriflo 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-2016-RN-01165-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-09-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01165-1
  • 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
    It has been found that the current ifu includes an incorrect cleaning and sterilisation procedure. the ifu (version 14) has been updated to include the new validated cleaning and sterilisation instructions, including the use of a new cleaning solution and wipes, specific dilution directions and contact times, specific lumen flushing instructions and changes to the sterilisation temperature and time.
  • Action
    Debriflo is providing users with a copy of the revised IFU (Version 14) with the new cleaning and sterilisation instructions.

Device

Debriflo Ultrasonic Wound Irrigation Hand-piece
  • Model / Serial
    Debriflo Ultrasonic Wound Irrigation Hand-pieceAll lot numbers affectedARTG Number: 265127
  • Manufacturer
    Debriflo Pty Ltd

Manufacturer

Debriflo Pty Ltd
  • Source
    DHTGA