Events

Recall of WECK Visistat 35R Disposable 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-2017-RN-00508-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-04-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00508-1
  • 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
    For a single product lot, teleflex medical has identified a labelling error on the boxes which contain six individually packaged and labelled device units. some boxes are labelled as containing visistat wide devices, when they in fact contain visistat regular devices. the individual units are correctly labelled with the actual size of the device. the labelling error applies only to some units of sales boxes in the affected lot number. it is unlikely that the use of these products will result in any adverse health consequences, although it is possible there could be a delay of the procedure.
  • Action
    Teleflex is advising users of the labelling error, and requesting that they place a copy of the customer letter detailing the issue with the affected lot.

Device

WECK Visistat 35R Disposable Skin Stapler

Manufacturer

Teleflex Medical Australia Pty Ltd