Class Exempt Medical Device Recall Question

#1
Hello,
I am reaching out in hopes of receiving guidance on whether or not to issue a voluntary recall. We manufacture a class 1 exempt medical device and private label this product for a multitude of distributors. Part of this finished good includes an artwork tyvek pouch. We have discovered through customer feedback complaints and internal confirmation, that a supplier of ours imprinted the incorrect GTIN number on the tyvek pouch and this product has made it out into the field. Could someone please elaborate if I should issue a voluntary class 3 recall for the products affected?

Thanks in advance,
Mike
 
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#2
I cannot advise you on whether you should conduct the correction or removal or not, but if you do, then you have to document it and maintain the documentation. Device classification is irrelevant.
FDA does not require reporting of Class III recalls. However, if this issue affects Canada, and you decide to take action, then you would most likely have to report because Canada has broader reporting criteria.
 
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