Events

Recall of Suction Tube

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by ConvaTec 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-2015-RN-00514-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00514-1
  • 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
    An internal assessment of product complaints has confirmed that these devices are not meeting the manufacturer's specifications. specifically, the connector part for application to the suction devices in these lots, has failed to meet its required reliability. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
  • Action
    Convatec is requesting end users to quarantine the affected product and return to their distributor for replacement or credit. This action has been closed-out on 11/08/2016.

Device

Suction Tube
  • Model / Serial
    Suction TubeSterile Codes: 530.25.200, 530.25.300, 530.25.450, 530.25.600, 530.25.800, 530.30.200, 530.30.300, 530.30.450, 530.30.600, 533.30.300Non-sterile Codes: 533.25.050, 533.25.100, 533.25.150, 533.25.200, 533.25.300, 533.25.450, 533.25.600Multiple BatchesARTG Numbers: 173916 (Sterile) & 204281 (Non-sterile)
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd