Events

Alerta De Seguridad para Name of INTRAFIX PRIMELINE AIR IL Technical Name: Family of Gravitational Infusion Equipment for Parental Solutions and Medications ANVISA Registration Number: 80136990540 Hazard Class: II Model Affected: 401450P Serial Numbers Affected: 17A20LB026

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
    2270
  • Fecha
    2017-04-13
  • 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
    Interruption of the use of said lot numbers, segregation thereof and information to Laboratorios B. Braun SA, for collection.
  • Causa
    By means of the publication in official gazette of the state of rio de janeiro of april 12, 2017 (year xliii - no. 068 part i), portaria svs no. 90, dated march 23, 2017, the subsecretariat for health surveillance ( suvisa) determines, as a measure of sanitary interest, the prohibition, suspension of sale and use, and collection of the batch of related product described, within the scope of the state of rio de janeiro. importantly, we have historically had no recorded complaints, or occurrences of adverse events involving the product batch in question. however, b. braun laboratories is initiating a recall with the product involved, throughout the national territory.
  • Acción
    Field Action Code AC / 03/2017 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for further destruction.

Device

Name of INTRAFIX PRIMELINE AIR IL Technical Name: Family of Gravitational Infusion Equipment for ...

Manufacturer

Laboratórios B. Braun S.A.