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.
See a list of details to help identify the product
Reason 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.
Details to help identify the product
Supplier running the recall
Coloplast Pty Ltd
Who sold the product
Medical distributors and hospitals
Identifying product features
The following lot numbers of the Trident catheter valve are subject to the recall:
2565208
2646228
2662994
2696297
2701396
2708828
2724652
2730835
2793517
2800400
2812339
2819240
2825445
2887949
2918547
Identifying numbers
Other identifying numbers
The following lot numbers of the Trident catheter valve are subject to the recall:
2565208
2646228
2662994
2696297
2701396
2708828
2724652
2730835
2793517
2800400
2812339
2819240
2825445
2887949
2918547
2565208
2646228
2662994
2696297
2701396
2708828
2724652
2730835
2793517
2800400
2812339
2819240
2825445
2887949
2918547
Where the product was sold
Nationally
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2011/12939 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Australian Competition and Consumer Commission if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.
