Coloplast Pty Ltd—Trident Catheter Valve

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.

Identifying 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

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

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.

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.

Product category