Medical device manufacturer, Coloplast, is initiating a medical device recall regarding three lots (2769329, 2799062 and 2823831) of Catheter Valve (item number: 380851).

A sterility test on Coloplast Catheter Valve has failed, which raises concerns over the sterility of the catheter valves. Coloplast has not received any complaint on the catheter valve related to this issue and therefore no signals for safety concerns. It is assumed that the catheter valve is used in a non-sterile environment. Under this assumption the lack of sterility is very unlike to affect the patient and user’s safety.

Coloplast is notifying the affected customers. Please refer to the attached Field Safety Notice for detailed recommendations.