Events

Alerta De Seguridad para GLASS BOTTLE FOR PLASMA HARVESTING AND STORAGE (PLASMACOL)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Laboratorios 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
    673
  • Fecha
    2002-08-21
  • 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
    The product PLASMACOL - glass bottle for plasma collection and storage had the application for registration refused in accordance with Administrative Rule 1376 chapter 3, item 1.1. III - DONOR BLOOD COLLECTION 1. General Instructions 1.1. The collection of blood from the donor should be done aseptically through a venipuncture using a closed system of specially designed plastic bags, disposable, pyrogen-free and sterile
  • Causa
    Rejected pursuant to ordinance no. 1376, chapter 3, item 1.1, portfolio n ° 1376, of november 19, 1993 approves amendments to administrative rule no. 721 / gm, of 08/09/89, approving technical norms for the collection, processing and transfusion of blood, components and derivatives, and other measures.
  • Acción
    operated for manufacturing and exposing the sale PLAMACOL - vacuum glass bottle for plasma collection and storage, contrary to current health legislation. Interdicted as a measure of health interest

Device

GLASS BOTTLE FOR PLASMA HARVESTING AND STORAGE (PLASMACOL)

Manufacturer

Laboratorios B. Braun S.A
  • Source
    ANVSANVISA