Events

Alerta De Seguridad para Tubes, blood collection, Plasma Separator Tubes Vacutainer Plus 45 ml 13 x 100. catalog number: 367962; Number of lots: 1008353

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BD Vacutainer Systems Div BD.

¿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
    331
  • Fecha
    2001-11-09
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    Some of the tubes above did not have the required amount of lithium heparin. the distributor started the removal by letter dated august 17, 2001.
  • Acción
    Check out BD Vacutainer Systems has already contacted you. Identify and isolate all affected products in your inventory. For more information, contact your local representative or directly with BD Vacutainer Systems at (888) 237-2762 in the United States. ANVISA is interested in following if there was good collaboration of the distributor with its laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.

Device

Tubes, blood collection, Plasma Separator Tubes Vacutainer Plus 45 ml 13 x 100. catalog number: 3...

Manufacturer

BD Vacutainer Systems Div BD
  • Source
    ANVSANVISA