Events

Alerta De Seguridad para ALL PRODUCTS OF THE COMPANY SANTE TEXTIL LTDA.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por SANTE TEXTIL LTDA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1203
  • Fecha
    2012-11-21
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Anvisa takes this measure considering that, in Investigative Inspection on 09/12, the company was not located at the declared address. In addition, the Sanitary Vigilance of Joinvile reported that the company had requested the shutdown of its manufacturing activities in 05/2012. Invoices were evidenced after this date. In Investigative Inspection was spotted production in place without Operation Permit. Anvisa / Utvig follows this case.
  • Causa
    Suspension determination of manufacturing, distribution, trade and use. seizure and destruction of existing stock in the market, according to resolution - re n °. 4,843, dated november 12, 2012. dou n ° 219 of 11/13/2012 attached. http://portal.Anvisa.Gov.Br/wps/wcm/connect/41c92d804d87ef40a4e5e5c116238c3b/re4.843.Pdf?mod=ajperes.
  • Acción
    Check the product for stock and segregate. Do not use the product. Contact your local Sanitary Surveillance to monitor product destruction. Contact supplier to negotiate refund.

Device

ALL PRODUCTS OF THE COMPANY SANTE TEXTIL LTDA.

Manufacturer

SANTE TEXTIL LTDA
  • Source
    ANVSANVISA