A review of the dhr and inspection records was conducted, and similar concerns were found.After three notifications, there has been no samples returned for review for ln 11432919.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.However, due to the number of similar complaints regarding lower- level lot numbers for the stopcock body, this complaint is confirmed.A definite root cause for the leakage could not be determined without the sample to review.A possible root cause is that there was a partial occlusion in one of the stopcock body ports which under pressure resulted in leakage.Another possible root cause could be related to damage to the stopcock body when the core/handle was assembled.Possibly the assembly caused a crack in the stopcock body.The stopcock bodies are being 100% inspected for occlusions and the assembly of the stopcock body and the core/handle are being 100% leak tested until this issue has been resolved.
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