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 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.
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.
Customers with these catheter valves have been advised to immediately stop distribution and use of the affected lots.
No other lot numbers or product codes are affected by this recall.
Neither TGA nor Coloplast have received any complaints related to lack of sterility of the Trident Catheter Valve.
Information for health professionals and customers
Please check your supplies of Trident Catheter Valves to determine if you have affected lots.
Customers affected by this recall should call the Coloplast customer service number: 1800 653 317.
Coloplast will arrange for the Trident Catheter Valve or valves to be recovered and replacement stock, or a credit note, to be issued.
Information on how to report a suspected problem with a medicine or medical device to the TGA can be found at Reporting Problems.
The affected lots
The following lot numbers of the Trident Catheter Valve are subject to the recall:
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.