Events

Recall of Alaris SmartSite Needlefree Connector

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-2014-RN-00119-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00119-1
  • 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
    Carefusion has identified potential risks with model code 2000e and lot numbers listed due to connection issues. the affected smartsite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. leakage may also be observed if the connector disconnects from the female luer during infusion. an inability to disconnect may require replacement of a line.
  • Action
    Carefusion is requesting users to segregate and return unused stock of connectors with polycarbonate housing to Carefusion. Polycarbonate materials were introduced because they provide more resistance to isopropyl alcohol than the acrylic housing hub. Now that the 2000E polycarbonate version will no longer be available, please remind staff that when accessing the valve, remember to Swab The Hub every time, do not swab the whole body of the device and take care to follow instructions during connection and disconnection of the SmartSite connector.

Device

Alaris SmartSite Needlefree Connector
  • Model / Serial
    Alaris SmartSite Needlefree ConnectorModel Number: 2000EBatch Numbers:13106451, 13046117, 13106355, 13045933, 13106754, 13086446, 13106753, 13096012, 13115734, 13095674, 13115872, 13095579, 13105584, 13095237, 13095913, 13106096, 13095914, 13095675, 13096488, 13106260 & 13106497ARTG Number: 189737
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd