Events

Recall of Peristeen Anal Irrigation System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Coloplast 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-00087-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00087-1
  • 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
    Following the publication of a review article on the best practice of transanal irrigation in adults, and post-market surveillance coloplast has decided to update the instructions for use. the update includes changes to the sections indication, contraindications, precautions, warnings and introduces instruction for more thorough patient examination before starting anal irrigation treatment. the potential risks that may result from the use of the device have not changed and there are no changes or modifications to the peristeen anal irrigation system.
  • Action
    Coloplast is writing to all hospitals and patients to inform them of the updates to the instructions for use. Further information on this issue has been provided on the TGA website at - http://www.tga.gov.au/safety/alerts-device-peristeen-anal-irrigation-system-140219.htm#.UwWXnbTTQgs

Device

Peristeen Anal Irrigation System
  • Model / Serial
    Peristeen Anal Irrigation SystemAll lot numbers affectedARTG Number: 135449
  • Manufacturer
    Coloplast Pty Ltd

Manufacturer

Coloplast Pty Ltd