Alerta De Seguridad para Heart Valves

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Resolution - RE nº 2.287, of November 29, 2002 DOU of 02/12/2002 The Director of the Collegiate Board of the National Sanitary Surveillance Agency, in the use of its attribution granted by Administrative Rule 570, of the Chief Executive Officer , of October 3, 2002; considering paragraph 3 of art. 111 of the Internal Regulations approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering the arts. 7, 12, 50 and 51 of Law 6360 of September 23, 1976, combined with arts. 1, 8 and 10 of Decree No. 79,094 of January 5, 1977; considering Resolution RDC No. 59 of June 27, 2000; considering Article 10, items I, XV, XXIX and XXXV, of Law No. 6,437 of August 20, 1977; considering Provisions of Infringement n ° 151/2002 and n ° 152/2002, the Term of Cautelar Interdiction n ° 150/2002 n ° 154/2002 resolves: Article 1 To determine, as a measure of sanitary interest, the organs that are part of the National System the precautionary interdiction of the heart valve products produced by the company TRI Tecnologias Ltda. located at R. Kremelin, 60 Nova Lima-MG and R. Silva Lobo, 1670 Belo Horizonte-MG, for not having operating authorization in the first address, for producing products registered with another company and for failing to comply with Good Manufacturing Practice. Art.2 This Resolution comes into force on the date of its publication. CLÁUDIO MAIEROVITCH PESSANHA HENRIQUES