And ISTR that just around the time I entered the medical device industry, that this is exactly what happened to Abbott and they were forced to remove some of their products from the market for months until they could bring their quality system back up to FDA satisfaction.

Hard to believe that it was so long ago. Man, I'm old :-) https://www.chicagotribune.com/news/ct-xpm-1999-11-03-991103...