Events

Recall of Biatain Ag Cavity Filler

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-2018-RN-00086-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00086-1
  • 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
    Coloplast has been made aware of concerns regarding the sterility of biatain ag cavity filler. the device may be compromised due to a quality issue that has occurred in the production process. no complaints for this issue have been reported to date.
  • Action
    Coloplast is advising affected customers to inspect inventory for affected stock. Affected stock should then be returned to the sponsor.

Device

Biatain Ag Cavity Filler
  • Model / Serial
    Biatain Ag Cavity FillerItem number: 3962801800Batch/Lot No: 5868783Expiry: 5 September 2020 ARTG Number: 160599
  • Manufacturer
    Coloplast Pty Ltd

Manufacturer

Coloplast Pty Ltd