The Trident catheter valve is used for connecting a urinary catheter to an overnight drainage bag. It gives users the opportunity to retrain the bladder and reduce the reliance on urine bags.
The following lot numbers of the Trident catheter valve are subject to the recall:
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 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.
Where the product was sold
Traders who sold this product
Medical distributors and hospitals
Coloplast Pty Ltd
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.
Other regulator reference numbers