Recall of BD Q-Syte Luer Access Split Septum Device(Connector designed to allow access to injection sites for delivery of medication)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Becton Dickinson 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
  • Event ID
  • Event Risk Class
    Class I
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Some units have an off-centred slit in the silicon septum resulting in a thinner column wall. when actuated, units with a thinner column wall may tear leading to leakage of infusate/medication or blood from the side vent opening. in addition to leakage, the manufacturer has identified that there is a smallpotential risk for air to enter the bloodstream which could result in air embolism.
  • Action
    Customers are advised to discontinue use of and immediately quarantine any of the affected stock. This action has been closed-out on 09/08/2016.