Trident catheter valve

Urgent medical device recall

Concerns over the sterility of the affected lots were raised following the failure of the sterility testing conducted by the manufacturer.

Published

5 December 2011

Level:	Consumer
Class:	II
Reference:	RC-2011-RN-01146-3
Date agreed:	30 November 2011
Product:	Trident Catheter Valve (Used with urological catheter) Item number: 380851
ARTG number:	107139
Batch number:	2565208 2646228 2662994 2696297 2701396 2708828 2724652 2730835 2793517 2800400 2812339 2819240 2825445 2887949 2918547
Sponsor:	Coloplast Pty Ltd
Contact:	1800 653 317 - Coloplast Customer Service
Reason:	Concerns over the sterility of the affected lots were raised following the failure of the sterility testing conducted by the manufacturer.

Please refer to the TGA safety alert: Trident valve catheter - Model Number: 380851 for more detailed information.

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I & II recalls are considered to be safety related recalls.

Product types