Events

Recall of Life Standard Package Cavity Liner (Calcium Hydroxide)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Kerr 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-2013-RN-00709-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-07-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00709-1
  • 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
    Kerr australia has received reports that the life regular set cavity liner base material is too thick to extrude from the tube or mix with the catalyst.
  • Action
    Kerr Australia is requesting users to discard affected products from use.

Device

Life Standard Package Cavity Liner (Calcium Hydroxide)
  • Model / Serial
    Life Standard Package Cavity Liner (Calcium Hydroxide)Life Standard Package Regular Set Part Number: 14500Life Standard Export Package Regular SetPart Number: 29674Lot Number: 2-1152ARTG Number: 137056
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd