Events

Alerta De Seguridad para RESPIRATOR EXHAUST VALVES VALVE ASSEMBLIES

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por INSTRUMENTATION INDUSTRIES 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
    156
  • Fecha
    2000-07-24
  • 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
    Rings used in the diaphragm mechanism were inadvertely molded with the wrong nucleus pin, which could result in the leakage of the expiration valve if processed and remote. the manufacturer started a removal by correspondence dated 24 july 2000.
  • Acción
    MAKE SURE THAT YOU HAVE RECEIVED THE DATED CHECK OF 24 JULY 2000 FROM INSTRUMENTATION INDUSTRIES. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. FOR PRODUCT REPLACEMENT OR FOR FURTHER INFORMATION, CONTACT YOUR INSTRUMENTATION INDUSTRIES REPRESENTATIVE

Device

RESPIRATOR EXHAUST VALVES VALVE ASSEMBLIES

Manufacturer

INSTRUMENTATION INDUSTRIES INC
  • Source
    ANVSANVISA