Coloplast Pty Ltd—Trident Catheter Valve
What are the defects?
The recall is being conducted because a routine sterility test on the Trident catheter valve in a particular set of lots has failed. This raised concerns that the valves in these lots may not be sterile.
What are the hazards?
To date, no additional risks have been identified as a result of the use of the affected catheter valves over and above the normal risk of infection with the use of urinary catheters.
What should consumers do?
Customers with these catheter valves have been advised to immediately stop distribution and use of the affected lots. Customers affected by this recall should call the Coloplast customer service number: 1800 653 317.
Medical distributors and hospitals
Australian Competition and Consumer Commission is the responsible regulator for this recall.