Events

Recall of Haemoband PLUS

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Horten 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-2018-RN-00176-2
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-03-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00176-2
  • 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
    Horten medical is re-issuing the instructions for use (ifu) document for the haemoband plus.This product defect correction was initiated as the haemoband plus, on one occasion, did not load the ligation band. there was no patient danger involved. as a result of this incident, haemoband surgical through horten medical have taken the decision to replace the instructions for use with an updated ifu, describing the procedure.
  • Action
    Horten Medical is providing updated Instructions for Use, and undertaking user training.

Device

Haemoband PLUS
  • Model / Serial
    Haemoband PLUSAll lots affectedARTG Number: 136643(Horten Medical - Ligator, haemorrhoid)
  • Manufacturer
    Horten Medical Pty Ltd

Manufacturer

Horten Medical Pty Ltd
  • Source
    DHTGA