Events

Recall of WECK Auto Endo5 Automatic Hem-o-lok Clip Appliers

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-01353-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01353-1
  • 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 has identified certain lots of weck auto endo5 automatic hem-o-lok clip appliers have a nonconformity that may cause clips to misload, jam, or fall out of the applier. there could be a delay in procedure if an applier becomes jammed or if a clip falls out of an applier.
  • Action
    Teleflex is advising users to inspect stock and quarantine all units from listed product and lot numbers. Teleflex will arrange collection of product from affected users.

Device

WECK Auto Endo5 Automatic Hem-o-lok Clip Appliers
  • Model / Serial
    WECK Auto Endo5 Automatic Hem-o-lok Clip AppliersProduct Code: AE05MLLot Numbers: 73F1600689, 73F1600694, 73G1600431, 73H1600666, 73H1600667, 73H1600668ARTG Number: 126369 (Teleflex Medical Australia Pty Ltd - Applier, surgical, clip, haemostatic, single use)
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd