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Trident catheter valve

Related information

Urgent medical device recall

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.