Events

Alerta De Seguridad para LATEX SURGICAL GLOVE DESCARPACK (Registro Anvisa: 10330660023).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Descarpack Descartáveis 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
    1038
  • Fecha
    2010-12-23
  • 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 DRC 05 of February 15, 2008, surgical gloves and gloves of non-surgical procedures of natural rubber, synthetic rubber or mixture of natural and synthetic rubbers, under sanitary surveillance regime, must meet the conformity certification requirements in the under the Brazilian System of Conformity Assessment (SBAC). #### 06/30/2011 - The company Descarpack proceeded with the collection and destruction of the remaining products, object of this Sanitary Alert, proven by the Certificate of Co-processing # 02348/2011, issued by the company Environmental Engineering Momento, accompanied by the Municipal Visa of Ilhota / SC. The Authorization for Use of the Seal of Compliance has been reacquired as correspondence of the Falcão Bauer Institute of June 20, 2011. ####
  • Causa
    Suspension of the authorization to use the seal of conformity identification motivated by the disapproval in the semi-annual maintenance test carried out by the falcão bauer institute of quality.
  • Acción
    (1) Discontinuation of use and segregation of the product in stock. (2) forward to Anvisa (tecnovigilancia@anvisa.gov.br) the following information: batch / quantitative no. / Date of acquisition. (3) make contact with the record holder for possible recall.

Device

LATEX SURGICAL GLOVE DESCARPACK (Registro Anvisa: 10330660023).

Manufacturer

Descarpack Descartáveis do Brasil Ltda.