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
A pre-processing culture performed on a companion allograft (aortic valve & conduct sg) tested positive for staphylococcus aureus.
조치
The firm, Cryolife, sent an "Urgent-Human Tissue Recall" letter dated January 7, 2011 to the consignee/customer. The letter describe the product, problem and action to be taken by the customer. The customer was instructed to determine if any additional patient surveillance or intervention was necessary, and to complete and return the enclosed postcard affirming that the notification was received.
If you have any questions, please contact Cryolife's Medical Director at 1-678-290-4403.