Events

Alerta De Seguridad para CONTAINER STRYKER (12 Instrument Sterilization Tray). Model under risk: 00-000-242-0000-12. Anvisa Registry n ° 80005439008.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por STRYKER DO BRASIL 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
    1468
  • Fecha
    2014-12-01
  • 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 gravity steam sterilization method (121øC to 30 minutes) was removed from the reprocessing guide (1000400920, Rev. D), because of the remote possibility of infection. The download of the new Reprocessing Guide, part number 1000400920 Rev. E, should be done from the link URL: www.stryker.com/12instrumenttray
  • Causa
    The gravity sterilization parameters provided in the sterilization reprocessing guide of 12 instruments (1000400920 rev. d) did not fully consider all worst case scenarios during the validation tests, and there is a possibility of infection.
  • Acción
    Updating Instructions for Use Information. The product user should discard any prior use instructions for his 12 Instrument Sterilization Tray and download the new reprocessing guide (Rev E) made available by the company (see CLARIFICATION field).

Device

CONTAINER STRYKER (12 Instrument Sterilization Tray). Model under risk: 00-000-242-0000-12. Anvis...

Manufacturer

STRYKER DO BRASIL LTDA.
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    ANVSANVISA