Events

Recall of 3M ESPE Adper Single Bond 2

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by 3M 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-2016-RN-00132-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00132-1
  • 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
    3m australia is undertaking a recall for the affected batch as the outer pouches of the 3g vials have been incorrectly labelled as 6g. the product has been manufactured to specification and will work as intended.
  • Action
    3M Australia is advising users to inspect stock and quarantine affected units. Affected stock will be replaced with unaffected product or a credit note issued. This action has been closed-out on 25/01/2016.

Device

3M ESPE Adper Single Bond 2
  • Model / Serial
    3M ESPE Adper Single Bond 2Catalogue Number: 51202Lot Number: N711552 Expiry Date: May 2018ARTG Number: 109870
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    DHTGA