Events

Alerta De Seguridad para Intrafix Compact Air FS - Registration No. 80136990743 - Model 441723P - lots: 14K21LA724, 14K21LA725, 14K21LA726, 14K22LA726, 14K22LA727, 14K22LA728, 14K22LA728, 14K22LA737, 14K22LA737, 14K27LA737,14K27LA738, 14L08LA752, 14L08LA753, 14L10LA753, 14L10LA756, 14L10LA755.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Laboratórios B. Braun S.A..

¿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
    1492
  • Fecha
    2014-12-19
  • 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
    According to the manifestation of the company, DC Flexible Chamber 2000 (lS322126E) is imported from another unit of group B.Braun (Vietnam). The manufacturer unit has been informed and the problem is under investigation.
  • Causa
    The company holding the registration informs that it has been identified the possibility of leakage in the base of the dc 2000 flexible chamber amber in isolated units of the product.
  • Acción
    The company that holds the registration in Brazil requests the interruption of the use, distribution and segregation of said lots still in the customer's stock, information to Laboratorios B. Braun SA of the quantities of existing units of each lot. Any doubt, contact the company: atendimento.Reclamacao@bbraun.com

Device

Intrafix Compact Air FS - Registration No. 80136990743 - Model 441723P - lots: 14K21LA724, 14K21L...

Manufacturer

Laboratórios B. Braun S.A.