Events

Recall of Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tubing set)BL200 BD Pre Post

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Gambro 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-2013-RN-00086-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00086-2
  • 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
    Gambro has identified a potential for increased likelihood of clotting following the introduction of the new venous chamber on conventional bloodlines which are used with the integra and ak machines. the new venous chamber design may increase the likelihood of clotting due to the presence of potentially stagnant areas beside the blood flow inlet.
  • Action
    Gambro is providing additional instructions for use for the correct blood level setting in the venous chamber. In addition, Gambro will discontinue the new design and re-introduce the original design.

Device

Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tub...
  • Model / Serial
    Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tubing set)BL200 BD Pre Post;Product Code 114635, Batch Numbers from 1240 to 1303BL208BD;Product Code:114557Batch numbers from 1242 to 1304BL223 PB;Product Code: 114636Batch Numbers from 1252ARTG Number: 141589
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd