March 8, 2023
That Advisory Notice Might be a Recall
I received a question today wondering if user facilities should be notified to quarantine devices if a device safety issue is suspected. The answer is yes, but with great care. Specifically, if a device safety issue suspected with distributed units, then the manufacturer certainly can advise affected parties, like user facilities, to immediately quarantine the product while an investigation and risk assessment are underway. But I’ve seen some prominent multinational medical device corporations advise to be VERY careful and aware that such a quarantine instruction and field action could be automatically considered by FDA to be a recall.