Events

Recall of Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)

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-2014-RN-01214-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01214-1
  • 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
    Gambro renal products is advising the customers of the possibility of a tear in the individual sterile barrier packaging on some of its polyflux revaclear/ polyflux revaclear max dialysers. the nature of the defect is such that it is isolated to the package only; the dialyser itself is not damaged. the tears are only on the printed white tyvek side of the packaging and are readily visible. a tear in the package is a sterility breach; if the product is then used to treat a patient, there is a remote risk of infection. however, that risk is extremely unlikely. even if the packaging is compromised, the protection caps on the blood ports of the dialyser are protecting the blood fluid path of the device from a potential contamination. gambro has not received any reports of adverse patient events.
  • Action
    Gambro Pty Ltd is requesting the customers to inspect their inventory, discontinue use immediately and quarantine the affected product. Gambro will arrange for the affected stock to be recovered and replacement stock, or a credit note, issued.

Device

Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)
  • Model / Serial
    Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)Product Codes: 110633 & 110634Multiple lot numbers are affectedARTG Number: 194549
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd