Events

Recall of Cure Sleeve (a dental barrier sleeve for curing light to prevent cross contamination)

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-2015-RN-00173-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00173-1
  • 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 corporation received complaints that cases of cure sleeves labelled with part number 4513 contained inner boxes with part number 4500. there is a low risk associated with the use of this product because the smaller sleeve size is unlikely to able to be applied to the larger tips. if the product is used; there would be a remote potential for cross contamination due to the tearing of the sleeve.
  • Action
    Kerr Corporation is contacting users to Recall affected units from the Market. This action has been closed-out on 15/07/2016.

Device

Cure Sleeve (a dental barrier sleeve for curing light to prevent cross contamination)
  • Model / Serial
    Cure Sleeve (a dental barrier sleeve for curing light to prevent cross contamination)Part Numbers: 4513C or 4513-1Kit/Refill/Syringe Lot Numbers: 201403010110ARTG Number: 161520
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd