| 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: |
|
| 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.