Company: American Red Cross Transplantation ServicesProduct: Cryopreserved heart valves Date: 3/11/04 The cryopreservation process dated 5/19/95, Computer Rate Controlled Freezer for Cryopreservation of Human Tissue, was not adequate. The validation included determining the maximum tolerance limits of the cryopreservation unit to freeze heart valves at a specified rate but only cryopreservation solution was used, not...Read More