Coloplast Trident Catheter Valve recall

There are concerns that the valves in these lots may not be sterile.
 
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  • Updated:8 Dec 2011
 

01.Coloplast Trident Catheter Valve recall

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

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

  • Nationally

Traders who sold this product

Medical distributors and hospitals

Supplier

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

RC-2011-RN-01146-3

 
 

 

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