Events

Recall of 5mm ENDOPATH XCEL Trocars with Optiview Technology

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-2018-RN-00284-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00284-1
  • 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
    Johnson & johnson medical has been advised that the manufacturer, ethicon, has become aware of reports from customers related to difficulty removing the obturator from the 5mm endopath xcel trocars with optiview technology.To date, no injuries have been reported as a result of this issue.
  • Action
    Johnson & Johnson Medical is advising users to inspect stock for affected product. Users should complete the Response Form provided with the Customer Letter to arrange for return and replacement of affected goods.

Device

5mm ENDOPATH XCEL Trocars with Optiview Technology
  • Model / Serial
    5mm ENDOPATH XCEL Trocars with Optiview TechnologyBladeless 5x100 StabilityProduct Code 2B5LTBatch Numbers: P4T58Y, P4T665, P4T83K, P4T88G, P4T927, R4000W, R4004GBladeless 5X75 StabilityProduct Code 2B5STBatch Numbers: P4T745, P4T906, P4T91HSleeve 5x100 StabilityProduct Code 2CB5LTBatch Numbers: P4T636, P4T63G, P4T708, P4T89NSleeve 5x75 StabilityProduct Code 2CB5STBatch Numbers: P4T686, P4T99K,P4T79AExpiry: between Sep 2022 - Jan 2023ARTG: 108472, 108482
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd