Events

Alerta De Seguridad para EQUIPMENT BURETA LA VITA, Registration no. 80288099006, lot: KLB5-120710A, Fab. 10/07/2012, Val. 09/07/2017

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por TKL IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS MÉDICOS E HOSPITALARES 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
    1358
  • Fecha
    2014-02-17
  • 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
    UPDATE - 09/02/2014 - The company completed the field action, the products collected were incinerated by the company SERQUIP - Waste Treatment Company, according to an award report dated 08/20/2014.
  • Causa
    According to the single sample tax report no. 3889.00 / 2013 issued by the adolfo lutz institute of the são paulo health secretariat, the equipment bureta la vita, lot klb5-120710a, was considered unsatisfactory in the test of appearance (foreign body presence).
  • Acción
    Resolution No. 489 of 14 February 2014 determined the suspension of distribution, trade and use as well as the collection of the product BURETA LA VITA, lot KLB5- 120710A. ///// UPDATE - 02/09/2014 - The company finished the field action, the products collected were incinerated by the company SERQUIP - Waste Treatment Company, according to an award dated 08/20/2014.

Device

EQUIPMENT BURETA LA VITA, Registration no. 80288099006, lot: KLB5-120710A, Fab. 10/07/2012, Val. ...

Manufacturer

TKL IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS MÉDICOS E HOSPITALARES LTDA.