Events

Recall of Ethicon HARMONIC ACE+ 7 Laparoscopic Shears

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical 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-00994-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00994-1
  • 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 determined that under extreme handling circumstances, damage, such as a hole, can occur in the tyvek lid due to an interaction between the advanced haemostasis button and tyvek, which would could compromise device sterility. the manufacturer has received no reports of adverse events for this issue.
  • Action
    Johnson & Johnson Medical are advising users of alternative products to use. Users are advised to inspect stock and quarantine any affected product to be returned to Johnson & Johnson. This action has been closed-out on 05/12/2016.

Device

Ethicon HARMONIC ACE+ 7 Laparoscopic Shears
  • Model / Serial
    Ethicon HARMONIC ACE+ 7 Laparoscopic Shears Product Codes: HARH23, HARH231, HARH36, HARH361, HARH45 and HARH451Batches with expiration dates before 08-2020ARTG Number: 118011
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd