| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00307-1 |
| Product Name/Description |
Hudson RCI One-Way Valve with Capped Monitoring Port
Product Code Number: 1644
Lot Numbers: 74K1502092 and 74K1601936
ARTG Number: 216042
(Teleflex Medical Australia - Valve, non-rebreathing) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
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 recognisable 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. |
| Recall Action |
Recall |
| Recall Action Instructions |
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.
This action has been closed out on 13/08/2019 |
| Contact Information |
1300 360 226 - Teleflex Medical Australia Customer Service |