Events

Recall of Syntel Vascular Catheters and Syntel Biliary Catheters (embolectomy catheter)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Applied 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-2012-RN-00855-3
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-08-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00855-3
  • 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
    Potential for packaging particulate matter to reside on the product.
  • Action
    Quarantine and return recalled lots to Applied Medical.

Device

Syntel Vascular Catheters and Syntel Biliary Catheters (embolectomy catheter)
  • Model / Serial
    Syntel Vascular Catheters and Syntel Biliary Catheters (embolectomy catheter)Syntel Vascular CathetersModel Numbers: A4403, A4405 to A4407 (inc), A4F00 to A4F08 (inc.)Lot Numbers: Multiple lots affectedARTG Number: 116754Syntel Biliary CathetersModel numbers: A4752Lot numbers: 1165670ARTG Number: 116815
  • Product Classification
    Gastroenterology-Urology Devices
  • Manufacturer
    Applied Medical Australia Pty Ltd

Manufacturer

Applied Medical Australia Pty Ltd