Re: Conduct Mock Recall on Medical Device Product
Hi,
Did anyone have experience or sample to share about mock recall on medical product? According to our auditor this to compliance to ISO 13485 under advisory notices clause – use of a medical device.
Welcome to the Cove. I have copy pasted a response i provided within a similar thread a few days ago. I hope this helps.
here is the link to the thread
Dummy Recall Guidelines - How to evaluate recall effectiveness
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I didn't have the luxury of a dry run. During the actual recall process I find that the biggest issues are:
- Where is the product
- How much product do they have or have left
- Who do we contact within the customers organization.
Our recall process is similar to the below and has worked for us very well.
Identify your product lot numbers and define how much product is affected.
Identify who has the recalled product and how much they have.
Identify who in the customers organization to contact.
Develop a letter stating a recall has been issued.
Develop a document explaining the defect and how to distinguish good product from suspect product and what to do with it or how to return it.
define how much suspect product they have.
Provide a post card type return postage paid mailer for them to sign and return stating they have received your contact and their status regarding suspect product.
Mail all of the above to your customers.
follow up on customers who haven't responded until you have established due diligence. During the return process maintain your statistics and you can verify effectiveness of your recall.
