Therapeutic Goods Administration (TGA), Australia, has issued a medical device safety alert concerning Hudson RCI One-Way Valve with Capped Monitoring Port [Product Code Number: 1644; Lot Number: 74K1502092 and 74K1601936], manufactured by Teleflex Medical.
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. To date, there have been no injuries reported as a result of this issue.
According to the manufacturer, 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.
The users are advised to immediately discontinue use and quarantine any products of the affected lot numbers.
For details, please refer to the following TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00307-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 April 2018