Events

Recall of TXR-ME (Tri-Ex Extraction Balloon with Multiple Sizing)(275 cm Length only)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook 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-2014-RN-00795-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00795-1
  • 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
    Cook medical has received complaints that some tri-ex extraction balloons may not fit through endoscopes with a 2.8 mm channel. the extraction balloon is labelled for use with a 2.8 mm endoscope.
  • Action
    Cook medical is requesting their customers to review their stock for the affected lot numbers and quarantine any affected product in preparation for return. This action has been closed-out on 03/06/2016.

Device

TXR-ME (Tri-Ex Extraction Balloon with Multiple Sizing)(275 cm Length only)
  • Model / Serial
    TXR-ME (Tri-Ex Extraction Balloon with Multiple Sizing)(275 cm Length only) Serial Numbers: W3372236(1), W3376524(1), W3427509(2), W3406080(1), W3388883(2), W3403192(2), W3334395(1), W3374821(1), W3376524(1), W3308765(2), W3333058(2), W3415262(2)ARTG number: 133685
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd