Events

Recall of PVC TUBING X-RAY (includes an x-ray detectable line and is used for securing the perfusion lines during cardiopulmonary bypass)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by De Fries Industries 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-00170-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-03-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00170-1
  • 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
    Following advice that some batches may have an open pouch seal, defries industries pty ltd is recalling the above batch of def3051 pvc tubing x-ray.
  • Action
    Customers are advised to inspect their stock and quarantine all units from the above batch number so that De Fries Industries can recover it and issue replacement stock or a credit note. This action has been closed-out on 31/05/2016.

Device

PVC TUBING X-RAY (includes an x-ray detectable line and is used for securing the perfusion lines ...
  • Model / Serial
    PVC TUBING X-RAY (includes an x-ray detectable line and is used for securing the perfusion lines during cardiopulmonary bypass)Catalogue number: DEF3051Batch number: 14-127Order code: DEF3051ARTG Number: 158941
  • Manufacturer
    De Fries Industries Pty Ltd

Manufacturer

De Fries Industries Pty Ltd