Recall of Smart Site Add-on Bag Access Device

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by CareFusion Australia 316 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-01631-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-16
  • Event Country
  • Event Source
    DHTGA
  • 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
    Reports have been received of leakages between the spike port and the drip chamber spike of the smart site add-on bag access device. separation and leakage between the spike port and the drip chamber spike may occur during infusion. to date, there have been no reports of serious injury or death in australia associated with the separation or leaks.
  • Action
    CareFusion is advising customers to quarantine affected stock. Customer Service will then arrange for the pick-up of the affected stock and issue a replacement or an account credit.

Device

  • Model / Serial
    Smart Site Add-on Bag Access Device Model Number: 10013365 Lot Numbers: 15055702, 15056299, 15056618, 15065645, 15075740, 15077085, 15085031, 15086107, 15095014, 15095411, 15106928, 15116928, 15126069, 15127413, 16015324, 16015607ARTG Number: 189737
  • Manufacturer

Manufacturer