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
Mislabeling; an allograft labeled as an aortic valve & conduit, actually contained a pulmonary valve and conduit.
조치
Consignee was notified by letter on 01/26/2004. The tissue was returned to CryoLife and destroyed.