Events

Recall of Extension Set(extension tubing for blood transfusion systems and standard intravenous administration sets)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by BMDi TUTA Healthcare 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-00719-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00719-1
  • 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
    Bmdi tuta healthcare has been made aware of an issue with the female luer lock (fll) connector. when connected to the male luer lock (mll) connector of another device the fll may crack and subsequently leak. the reported incident rate is low and the fault has not been reproduced in house.
  • Action
    BMDi TUTA is requesting the customers to inspect, discontinue use, and quarantine affected stock for replacement. BMDi TUTA is arranging for the return of any remaining stock

Device

Extension Set(extension tubing for blood transfusion systems and standard intravenous administrat...
  • Model / Serial
    Extension Set(extension tubing for blood transfusion systems and standard intravenous administration sets)REF 50.318H Lot No. 20141226ARTG Number 222156
  • Manufacturer
    BMDi TUTA Healthcare Pty Ltd

Manufacturer

BMDi TUTA Healthcare Pty Ltd