Events

Recall of Sapheon (Covidien) VenaSeal Closure System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-00376-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00376-1
  • 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 the potential for a sterility breach of the outer packaging (pouch) material. a breach of the outer pouch may compromise the outside surface sterility of the sealed inner tray and does not directly affect the sterility of the device componentsthis potential for a sterile breach in the outer pouch material was discovered during standard internal packaging tests. the breach in the pouch barrier may not be detectable by visual inspection of the product. medtronic has identified possible causes for the pouch damage and has taken actions to prevent distribution of product that may be affected by this issue.
  • Action
    Customers are asked to review their inventory, quarantine product, complete the customer confirmation certificate and return all unused product to Medtronic. This action ha been closed-out on 10/08/2016.

Device

Sapheon (Covidien) VenaSeal Closure System
  • Model / Serial
    Sapheon (Covidien) VenaSeal Closure SystemLot Numbers: 37399, Mnf date: 07/08/2014, Exp date: 2016-537621, Mnf date: 28/07/2014, Exp date: 2016-338407, Mnf date: 16/10/2014, Exp date: 2016-537417, Mnf date: 16/10/2014, Exp date: 2016-738756, Mnf date: 07/11/2014, Exp date: 2016-738863, Mnf date: 20/11/2014, Exp date: 2016-9ARTG Number: 194201
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia