Events

Recall of Halyard Closed Suction Kits with Flex Connector

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Halyard 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-2018-RN-00232-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00232-1
  • 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
    Halyard australia has been made aware of overseas reports indicating certain flex connectors supplied with 'halyard closed suction with flex connector' devices may become loose or disconnect before use or during use. if disconnection occurs during use, it will result in an open respiratory circuit and interruption of patient ventilation.To date, there have been no reports of permanent patient injury as a result of this issue. no reports of disconnect have been received from australian facilities to date.
  • Action
    Halyard is advising: - Before using the Flex Connector, evaluate its connection to the Swivel Connector of the Closed Suction adapter to ensure an adequate connection. Evaluation of the connection can be accomplished by pushing the Flex Connector onto the Swivel Connector. Users should refer to the images provided on the Customer Letter to establish whether an adequate connection has been obtained. - If a disconnection between the Flex Connector and Swivel Connector is observed during use, replace the Flex Connector with a new, sterile Flex Connector and ensure adequate connection

Device

Halyard Closed Suction Kits with Flex Connector
  • Model / Serial
    Halyard Closed Suction Kits with Flex Connector Multiple Product TypesARTG Number: 259994(Halyard Australia - Catheter, suction, general-purpose)
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Halyard Australia Pty Ltd

Manufacturer

Halyard Australia Pty Ltd