CryoLife
This article was originally published in The Gray Sheet
Executive Summary
CDC indicates an investigation of two reported allograft heart valve infections shows signs of fungal infection isolated on a culture of one of the explanted valves, according to CryoLife. The firm maintains its own analysis showed no infection in either valve. A related FDA inspection of the company's Kennesaw, Georgia facility resulted in a June 17 warning letter (1"The Gray Sheet" July 1, 2002, p. 10)...