Events

Recall of Sangofix set with hand pump (Blood/Solution Transfusion Set)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by B Braun 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-2016-RN-00185-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00185-1
  • 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
    This recall is initiated due to incorrect information provided on the labelling. in the course of routine quality tests, it was discovered that sangofix sets with hand pump contain dehp (approx. 1.6% per set). the sangofix sets, however, are labelled dehp-free.The mislabelling is limited to the affected article numbers as the dehp containing hand-pumps are only used in the specified products.
  • Action
    B. Braun is advising users to inspect stock and quarantine all units with the affected article codes. Affected stock can be returned to B. Braun and users will be issued a credit note. This action has been closed-out on 15/05/2017.

Device

Sangofix set with hand pump (Blood/Solution Transfusion Set)
  • Model / Serial
    Sangofix set with hand pump (Blood/Solution Transfusion Set)Article Codes: 4050192, 4050192H and 4050193All Batch Numbers affectedARTG Number: 137615
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd