Events

Alerta De Seguridad para Commercial Name: INJEX VACUUM - TUBES WITHOUT ADDITIVES FOR COLLECTING BLOOD TO VACUUM # Registration: 10160610019 # Hazard Class: II # Product Presentation: INJEX VACUUM - WHITE WITHOUT ADDITIVE: tubes of 13 x 75 mm; 13 x 100 mm tubes; tubes of 16 x 100 mm. ** INJEX VACUUM - RED WITHOUT ADDITIVE: tubes of 13 x 75 mm; 13 x 100 mm tubes; tubes of 16 x 100 mm. ** INJEX VÁCUO - TRAÇOS ELEMENTS WITHOUT ADDITIVE: tubes of 13 x 75 mm; 13 x 100 mm tubes; tubes of 16 x 100 mm. ** AFFECTED LOTS: 16; 8; 46; 249; 11; 17

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por INJEX INDÚSTRIAS CIRÚRGICAS LTDA.

¿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
    1369
  • Fecha
    2014-03-10
  • 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
    Recommendations for customers / users of the product, according to the company: "Keep the indicated batches segregated until collection and replacement by Injex, in order to no longer use a product that is in disagreement with your registration."
  • Causa
    In the registration of the product with anvisa it is stated that the sterilization process used will be "cobalt-60 gamma radiation sterilization", however for these lots the "electron beam sterilization" process was used.
  • Acción
    Collection and destruction by the company of the sterilized products in disagreement with its registration with ANVISA.

Device

Commercial Name: INJEX VACUUM - TUBES WITHOUT ADDITIVES FOR COLLECTING BLOOD TO VACUUM # Registra...

Manufacturer

INJEX INDÚSTRIAS CIRÚRGICAS LTDA
  • Source
    ANVSANVISA