Events

Recall of Hudson RCI One-Way Valve with Capped Monitoring Port

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Teleflex Medical 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-00307-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-04-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00307-1
  • 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
    It has been identified by the manufacturer that one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient. disconnection of the valve is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the valve is connected. however, disconnection of the valve in ventilator dependent patients without prompt response could lead to hypoxia, organ failure, or death.To date, there have been no injuries reported as a result of this issue.
  • Action
    Teleflex is advising users to immediately discontinue use and quarantine any products of the affected lot numbers. Teleflex will contact customers with affected product to arrange collection of goods and provide an account credit.

Device

Hudson RCI One-Way Valve with Capped Monitoring Port
  • Model / Serial
    Hudson RCI One-Way Valve with Capped Monitoring PortProduct Code Number: 1644Lot Numbers: 74K1502092 and 74K1601936ARTG Number: 216042(Teleflex Medical Australia - Valve, non-rebreathing)
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd