Events

Alerta De Seguridad para COMPRESSA SURGICAL GAZE HYDROPHILASE ESTERIL HERIKA, lot 0155 and lot 191012G11 - registration no. 80037490003

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por América Medical 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
    1368
  • Fecha
    2013-11-27
  • 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
    Services that have units of these lots should contact the company to arrange for the collection.
  • Causa
    Reprocessing in the aspect test of the product compressa surgical gaze hydrophila esteril herika, in accordance with the single sample analysis report 113.479 / 2013, issued by lacen ba, for lot 191012g11. presence of foreign body in inviolate packaging of lot 0155, as published in official gazette of the city of são paulo on 10/9/2013.
  • Acción
    Resolution RE No. 4,937 of December 23, 2013 was published, determining, as a measure of health interest, the suspension of distribution, trade and use, as well as the collection, throughout the national territory, of the product COMPRESSA SURGICAL SURGERY OF GAZE HYDROPHILA ESTERIL HERIKA , lot 191012G11. The COVISA Communiqué 029/2013 was published in the Official Gazette of the City of São Paulo on October 9, 2013, determining the interdiction and collection of the product COMPRESSA SURGICAL GAZE HYDROPHILA ESTERIL HERIKA, lot 0155.

Device

COMPRESSA SURGICAL GAZE HYDROPHILASE ESTERIL HERIKA, lot 0155 and lot 191012G11 - registration no...

Manufacturer

América Medical Ltda
  • Source
    ANVSANVISA