PRA number
2011/12939
Published date
Product description
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.
Reasons the product is recalled
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.
The hazards to consumers
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 consumers should 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.
Supplier
Coloplast Pty Ltd
Traders who sold this product
Medical distributors and hospitals
Where the product was sold
Nationally
Responsible regulator
Australian Competition and Consumer Commission is the responsible regulator for this recall.
