Safety Alert for MEDICAL EQUIPMENT

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.

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 provisions of items I, V and XXIX of Article 10 of Law 6,437 of August 20, 1977; considering the provisions of Article 50 of Law 6360 of September 23, 1976; considering the provisions of items VII, XV, XXIV, XXVI, of Article 7 of Law No. 9,782, of January 26, 1999; considering the Inspection Report carried out at the company Cardiotec on August 28, 2003, reporting the distribution of the product without registration of said company by the company UNIVENT; considering the AIF Infringement Notice No. 101 dated August 28, 2003, drawn up by VISA-DIR-I / SES-SP, resolves: Article 1 To determine, as a precautionary measure, as a measure of health interest, in all national territory, the suspension of the sale and distribution of health products (correlated) of the company UNIVENT ¿EQUIPAMENTOS MÉDICOS LTDA - ME, located at Rua Cururipe, n. 47, Parque Maria Luiza neighborhood, São Paulo / SP, for not having authorization of Operation issued by ANVISA.