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
Microorganisms were detected in distributed allografts.
조치
CryoLife Technical Representatives were notified by telephone on 02/04/2003 and 02/24/2003. Representatives subsequently notified their accounts via letter on/about 02/25/2003 informing the consignees of the removal and advised them not to implant the tissue if it has not been implanted and to place into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department ¿ Field Assurance, who will issue a Return Materials Authorization (RMA) number and will provide specific instructions for returning the tissue. A self addressed, stamped postcard was included to provide a response regarding the disposition of the tissue.
Health Canada was notified of all voluntary actions on the allografts distributed in Canada.