Events

Recall of HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER (WITH CLIPS) - ENDOSCOPIC

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TELEFLEX MEDICAL CANADA INC..

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
    16554
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    There is the possibility that a clip in the applier may be missing a boss. a boss is the part of the clip that is used to hold the clip within the applier jaws prior to application.

Device

HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER (WITH CLIPS) - ENDOSCOPIC
  • Model / Serial
    Model Catalog: 543965 (Lot serial: 73J1500280); Model Catalog: 543965 (Lot serial: 73J1500066); Model Catalog: 543965 (Lot serial: 73J1500440); Model Catalog: 543965 (Lot serial: 73J1500565); Model Catalog: 543965 (Lot serial: 73J1500065); Model Catalog: 543965 (Lot serial: 73k1500193); Model Catalog: 543965 (Lot serial: 73J1500566)
  • Product Description
    Weck AutoEndo5 Hem-o-lok 5 mm Automatic Endoscopic Hem-o-lok Applier;Weck AutoEndo 5 Hem-o-Lock (5mm Automatic Endoscopic Hem-O-Lok Applier
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.