Events

Recall of Disposable Myringotomy blade with handle (used during surgery on the ear drum to relieve pressure)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Olympus 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-01002-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01002-1
  • 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
    Olympus australia is issuing a product recall of the affected lot of the disposable myringotomy blade with handle, due to missing or compromised seals in the sterile packaging, therefore compromising the sterility of the product.
  • Action
    Olympus is requesting users inspect stock and quarantine any affected units. Affected stock will be replaced or a credit issues. This action has been closed-out on 29/08/2016.

Device

Disposable Myringotomy blade with handle (used during surgery on the ear drum to relieve pressure)
  • Model / Serial
    Disposable Myringotomy blade with handle (used during surgery on the ear drum to relieve pressure)Item Code: 70130791Lot Number: SD954316 ARTG Number: 142726
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd