Events

Recall of Flexi-Seal CONTROL Faecal Management System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Convatec Australia 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-00507-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00507-1
  • 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
    An internal assessment of product performance, including a review of customer feedback, has confirmed that flexi-seal control faecal management system is not meeting performance requirements for this product. specifically, the auto-valve has not been consistently performing relative to the inflation and deflation of the device’s retention balloon. in the event that the auto-valve does not perform properly related to inflation and deflation of the device’s retention balloon, there is the potential that medical intervention may be necessary. in accordance with the instructions for use supplied with the flexi-sealtm controltm faecal management system, the following events could occur:- leakage of stool around the device, and peri-anal skin breakdown;- rectal/anal bleeding due to pressure necrosis or ulceration of rectal or anal mucosa;- perforation of the bowel.
  • Action
    End users are advised to stop the use of all affected devices and return all affected products to their distributor for credit or replacement with unaffected product.

Device

Flexi-Seal CONTROL Faecal Management System
  • Model / Serial
    Flexi-Seal CONTROL Faecal Management SystemProduct code: 411107All lot numbersARTG number: 163198
  • Manufacturer
    Convatec Australia Pty Ltd

Manufacturer

Convatec Australia Pty Ltd