Fernando Leon Hello Mark, I have a few medical device clients. I will ask them if they have the information you are looking for.

Julie Omohundro Are you talking about a description of an investigation of the problem that led to a recall, its findings, and any resulting CAPAs that is to be sent to FDA?

Mark Proulx, CQA, cSSBB Julie O. Exactly. Don't need the details of the product at all, just an example of some merging written that upper management signed off on. I have some upper mgt here that are terrorizing my mid mgt with the "this is unacceptable" but won't tell them what they want (ostensibly because they just want to look like they know what they are talking about.) If I had examples of how successful companies, consultants have written theirs, I'd have something to show mid mgt and show upper mgt what other companies are submitting to the Agency.

Alan Barta Recalls are a highly regulated activity that requires immediate notification of a noncompliance that might affect users. Have conducted several myself. It works in steps that must occur on a timeline. First, companies who make medical devices and pharmaceuticals must record exactly where each and every items went. This is essential to bounding, that is, matching noncompliant batches with locations. The faster you recall, receive, and process to certificate of destruction, the better. But there's a lot of calling and emailing salespeople and users to produce a trace trail to make sure none slip through. The less costly and smarter approach is to measure, produce, inspect, recheck, and assure quality before delivery, but stuff today is so "supply chain" dependent, recalls, and patients harms, have become commonplace.

Gheorghe Ion Mija Hello everyone. I am in sales in a ditributor company of medical devices since 2000 and pass all steps from sales rep to upper mgt and also work for multinational companies. Alan have right about the procedure and this is well stipulated in the procedures at the base of ISO certificate. Regarding your question, Mark, it goes like this. If there is a recall based on a production problem, usually the middle mgt will take care, if there is a serious problem or a design problem, the upper mgt take action. Need example - look to the big producers - as bigger is the company as many recalls they have over time. Thanks.

Alan Barta I neglected to mention specifics of recalls, since I signed nondisclosure agreements. But, trust me, almost all recalls are extremely necessary, but usually involve small percentages of overall production. Examples include errant batches of major brands. Public seems to think that entire product line of any recalled brand name should be avoided, but recalls occur all the time BEFORE product is ever distributed, so don't get publicized.

Go to the FDA Website to see what information needed to submit an 21 CFR 806 report starting with an extensive investigation on number of complaints reported etc.

i believe the FDA website will have real examples you can view related to actual recalls