Events

Recall of ECHELON 60mm Endoscopic Linear Cutter Reloads, Black (Reload cartridge with two 60mm long triple-staggered lines of staples)

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-2013-RN-00541-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-05-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00541-1
  • 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
    There is a potential for incomplete staple line formation from the reload damage during the firing sequence. this may result in insufficient tissue apposition that could require surgical intervention to help achieve and maintain anastomotic integrity.
  • Action
    JJM is asking customers to quarantine any affected product in the inventory and return them.

Device

ECHELON 60mm Endoscopic Linear Cutter Reloads, Black (Reload cartridge with two 60mm long triple-...

Manufacturer

Johnson & Johnson Medical Pty Ltd