Events

Recall of Portex Thoracic Catheter and Connecting Tube

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smiths Medical Australasia 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-2018-RN-00357-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00357-1
  • 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
    Smiths medical became aware of a potential breach in the seal of the package on certain packaging lots. these packages were used in the manufacturing of certain portex thoracic catheters and connecting tubes, compromising the sterility of the devices. smiths medical has not received any reports of serious injury relating to this issue.
  • Action
    Smiths Medical is advising customers to quarantine all stock of the affected units. Upon receipt of a completed Response Form provided with the Customer Letter, a Smiths Customer Service Representative will contact users with a Return Material Authorisation Number to facilitate the return of the product and issue a credit.

Device

Portex Thoracic Catheter and Connecting Tube
  • Model / Serial
    Portex Thoracic Catheter and Connecting TubeThoracic Catheter 28Fangled Soft, Adult Connector, 10/CAModel Number: 200/812/280Multiple Lot NumbersARTG Number: 145749Smiths Medical Australasia - Portex Thoracic Catheter - Drain, thoracic
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd