Events

Safety Alert for INFRA LONG RED INVEL and FID INFRARED DOME

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Distributed by GOEN3 COMERCIAL LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    670
  • Date
    2002-03-20
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Art. 7 and art. 12 of Law no. 6,360, of September 23, 1976; § 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; 10, items II, IV and XXIX, of Law No. 6.437, of August 20, 1977; Art. 12 of Law no. 6,360, dated September 23, 1976, combined with articles 14 and 35 of Decree No. 79,094 of January 5, 1977
  • Reason
    Because they are being sold without registration with anvisa.
  • Action
    Determine, as a measure of health interest, throughout the national territory, the ban on the products INFRA VERMELHO LONGO INVEL and FID INFRARED DOME, distributed by the company GOEN3 COMERCIAL LTDA located at Av. Ribeiro Lacerda n.º 419, Jardim da Saúde, São Paulo / SP, because they are being sold without registration with ANVISA

Device

INFRA LONG RED INVEL and FID INFRARED DOME

Manufacturer

Distributed by GOEN3 COMERCIAL LTDA
  • Source
    ANVSANVISA