Events

Recall of Coban 2 Lite Compression Layer (active support bandage)

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-00207-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00207-1
  • 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
    The manufacturer has identified that during printing an operator error occurred where the foil used as the primary packaging for coban 2 lite shows "coban 2" as the product name. the compression bandage, the outer carton packaging, the corresponding instructions for use as well as the colour coding (green for coban 2 lite) is correct. if coban 2 lite is used by mistake for a patient requiring regular compression, the compression efficacy might not be sufficient. this would be noticed by the health care provider and corrected with the next bandage change.
  • Action
    3M Australia is advising users to inspect stock and quarantine any affected product for return or credit. This action has been closed-out on 30/01/2017.

Device

Coban 2 Lite Compression Layer (active support bandage)
  • Model / Serial
    Coban 2 Lite Compression Layer (active support bandage)Product Code: 20724ID Number: DH888822441Lot Number: 2017-21APExpiry Date: Dec 2017ARTG Number: 235181
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

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