Events

Alerta De Seguridad para Scale available (1) size 10, (2) size 11, (3) size 12, (4) size 15, (5) size 20. Lot. numbers: (1) 2410, (2) 2412, (3) 2293, (4) 2428, (5)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ZNC International Inc.

¿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
    245
  • Fecha
    2001-10-05
  • 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
    The scalp boxes listed above have sealing defects which may compromise the sterilization of the products. the manufacturer initiated the removal by means of a letter dated june 26, 2001.
  • Acción
    Check receipt of the letter dated June 26, 2001 from ZNC. Identify and isolate all inventory products. Do not use the affected products. ZNC recommends that you contact the supplier to exchange the affected product for replacement. For more information, contact your local representative or ZNC at

Device

Scale available (1) size 10, (2) size 11, (3) size 12, (4) size 15, (5) size 20. Lot. numbers: (1...

Manufacturer

ZNC International Inc
  • Source
    ANVSANVISA