Labeling of Medical Devices - Distributor replacing device serial number label

Chitchat said:

I have just been made aware that one of my customers (actually my distributor) in the US jurisdiction is removing the device serial number label which is applied at the manufacturing site and is the sole traceability to the Device History Record and applying their own serial number label. I'm not sure if the distributor is maintaining a log of the corresponding serial numbers for traceability purposes.

My question is what regulations or laws (if any) are being violated here? As a device manufacturer, what is my duty now that I am aware that this is occurring?

Please help!

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Chitchat said:

Al, thanks for your help on this. I guess I have some issues to sort out!

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