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Mattie718 replied to the topic Safety Recalls in the forum Introduction to Project Management 6 years, 7 months ago
I think there are different situations with the labeling which could result in either immediate corrective action or even a recall. As we have have heard before, labeling is one of the three core components of what constitutes a medical device so any type of failure to a label can be considered serious. If it’s in respect to the labeling perhaps peeling off, that may not be cause for market intervention since the doctor or patient should already be familiar of what it is and how it is used in case it falls off. On the other hand if the labeling contains wording or descriptions which are incorrect or misleading about the product and can result in user injury then it should probably be recalled immediately. While it is not ideal to have faulty products out in the market, certain exceptions should be taken sometimes to avoid the various negative implications of recalls.