Events

Recall of WECK Visistat 35W Skin Stapler

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Teleflex Medical 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-2016-RN-01545-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01545-1
  • 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
    Teleflex is recalling this product due to potential for an incomplete seal on the sterile package. the sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for infection to occur. a broken sterile seal on a sterile package is typically easily seen before use. no patient injuries have been reported related to this issue.
  • Action
    Teleflex is advising customers to immediately quarantine affected stock. Affected stock is not to be distributed. Teleflex will arrange for the collection of affected stock and will issue credit for returned stock.

Device

WECK Visistat 35W Skin Stapler
  • Model / Serial
    WECK Visistat 35W Skin StaplerCatalogue Number: 528235Batch Numbers: 73H1500255, 73K1500618ARTG Number: 126367
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd