U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Heart-Valve, Allograft - Product Code MIE
원인
The firm received additional information from the procurement agency indicating that yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis.
조치
Consignee was first notified by telephone on 11/10/2003, with a follow up letter sent 12/10/2003. If the tissue had been implanted the consignee was advised to forward that information to CryoLife''s Regulatory Department-Field Assurance. If the tissue had not been implanted the consignee was advised not to implant or further distribute the tissue. They were instructed to remove the tissue from the implantable inventory and to place it into quarantine pending return to CryoLife. A self addressed, stamped postcard was included to affirm receipt of notification and to acknowledge that the tissue had been placed into quarantine.