Events

Recall of Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Getinge 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-2018-RN-00435-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00435-1
  • 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 arterial cannula used for open heart surgery is normally equipped with a vent plug, which facilitates the de-airing of the cannula.The vent plug of our arterial cannula consists of sintered polyethylene, therefore the structure of the vent plug is porous and gas-permeable. after the de-airing process is completed the customer has to separate the vent plug from the cannula to connect the extracorporeal circuit.Getinge has been made aware that in some instances, the vent plug can break during the separation from the arterial cannula.
  • Action
    Getinge is advising customers to immediately return affected product to their local Getinge representative. Due to the discontinuation of the Surgical Perfusion Catheters/Cannulae product portfolio, Getinge are not providing replacement.

Device

Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256
  • Model / Serial
    Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256Multiple Material NumbersARTG Number: 206768Getinge Australia - Catheter, intravascular, general-purpose
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA