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
Cryolife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
조치
Consignees were notified by letter on/about May 6, 2004.
Donor #25741, Serial #6048048, Model #PV00* Donor #34696, Serial #6356176, Model #PV00* Donor #40017, Serial #6528252, Model #AV00* Donor #41180, Serial #6575609, Model #AV00* Donor #41204, Serial #6575862, Model #AV00* Donor #41737, Serial #6593488, Model #AV00* Donor #45446, Serial #6714974, Model #AV00* Donor #45592, Serial #6735875, Model #AV00* Donor #46183, Serial #6736590, Model #AV00* Donor #46484, Serial #6774373, Model #AV00* Donor #46505, Serial #6770996, Model #AV00* Donor #47518, Serial #6761788, Model #AV00* Donor #50045, Serial #7110160, Model #AV00* Donor #50098, Serial #7106597, Model #AV00* Donor #50953, Serial #7000596, Model #AV00* Donor #50982, Serial #7090443, Model #AV00* Donor #53789, Serial #7013389, Model #AV00* Donor #54935, Serial #7235057, Model #AV00* Donor #59111, Serial #7343716, Model #AV00* Donor #59407, Serial #7322607, Model #AV00