Warning Letter Roundup & Recap
This article was originally published in The Silver Sheet
Executive Summary
Karl Storz didn't have design validation data to show that a brush specified in the instruction manual for its Flex-X2 ureteroscope was appropriate for cleaning the device; QS and MDR reg violations identified at maker of coronary bypass cannulas. Six quality-related warning letters were listed by FDA from Dec. 18 through Jan. 14.