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Trident catheter valve
Urgent medical device recall
|Date agreed:||30 November 2011|
|Product:||Trident Catheter Valve
(Used with urological catheter)
Item number: 380851
|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.
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.