Events

Alerta De Seguridad para Hudson RCI Nebulizer, codes 031-28 and 031-33, registration no. 10342600026, batches affected - Annex

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Comercial Nacional de Produtos Hospitalares; Teleflex Medical.

¿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
    1441
  • Fecha
    2014-10-02
  • 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
    According to the manifestation of the company, to date no cases of adverse events have been identified. The company directs that the batches identified are not used as a precautionary measure, since this product must be sterile. Inquiries, please contact us at sac@cnph.com.br
  • Causa
    The manufacturer teleflex medical has identified that the nebulizer adapter packaging may be open or the sealing may be poor, which may affect the sterility of the product. the adapter is a sterile product.
  • Acción
    The company that owns the registration in Brazil is collecting the product. It instructs customers and distributors to segregate and return the products of the lots involved in this field action

Device

Hudson RCI Nebulizer, codes 031-28 and 031-33, registration no. 10342600026, batches affected - A...

Manufacturer

Comercial Nacional de Produtos Hospitalares; Teleflex Medical
  • Source
    ANVSANVISA