Events

Recall of 1322 3M Comply Lead Free Steam Indicator Tapes & 1355 3M Comply Lead Free Steam Indicator Tapes for Disposable Wraps 1322 3M Comply Lead Free Steam Indicator Tapes

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-2017-RN-00635-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-05-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00635-1
  • 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
    During a recent investigation, the manufacturer confirmed some rolls within the four (4) affected lots failed to meet the visual standard for colour development following exposure to steam sterilisation. if the product fails to meet the colour development standard it could be interpreted that the pack has not been exposed to an adequate sterilisation process.
  • Action
    3M Australia is requesting users to discontinue use of affected products and notify 3M to receive a refund or replacement. Distributors are requested to cease distribution of affected products and forward the recall notification to customers who have received the affected lots. Distributors are further requested to consolidate returned products from their customers with their own affected stock and notify 3M accordingly to receive a refund or replacement.

Device

1322 3M Comply Lead Free Steam Indicator Tapes & 1355 3M Comply Lead Free Steam Indicator Tapes f...
  • Model / Serial
    1322 3M Comply Lead Free Steam Indicator Tapes & 1355 3M Comply Lead Free Steam Indicator Tapes for Disposable Wraps 1322 3M Comply Lead Free Steam Indicator TapesStock Numbers: CT060934651 & CT060934669Roll Sizes: 1322-18MM & 1322-24MM (respectively)1355 3M Comply Lead Free Steam Indicator Tapes for Disposable WrapsStock Numbers: CT060934693 & CT060934701Roll Sizes: 1355-18MM & 1355-24MM (respectively)Lot No: 2018-04RA, 2018-05RB, 2018-06RC & 2018-06RD ARTG Number: 126363
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

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