Events

Alerta De Seguridad para LEMGRUBER DISPOSABLE GLOVES, PROCED BRAND, SIZE G (Registro Anvisa: 80256170001).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por TARGA 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
    1122
  • Fecha
    2012-03-28
  • 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 RDC 05, of February 15, 2008, the certification of gloves is a prerequisite for its commercialization. INMETRO, through its Ordinance 233/2008, establishes the directives for such certification. In the present case, the suspension of the Compliance Identification Seal occurred on 11/01/2011, due to non-conformity of the product to the "width" requirement, in the dimensional tests carried out in INT's laboratory. The information was received by the Anvisa Tecnovigilance Unit on 03/21/2012. #### FINALIZATION: The company forwards the final report of the Field Action and the respective Certificate of Destruction of the products collected (HZT 001309/2012). #### UPDATE - 12/28/2012 - The certifying body - INT, forward Notice CT / INT / DCER No. 132/2012, informing the compliance of the products from that date, withdrawing the suspension of use of the seal of conformity.
  • Causa
    Suspension of the product conformity identification seal, considering that it did not meet the criteria for certification of conformity established by inmetro ordinance no. 233/2008.
  • Acción
    All products referred to herein (Anvisa registry 80256170001, size G) must be identified and segregated by professionals and health services. Contact should be maintained with the record holder for collection and subsequent destruction of affected products.

Device

LEMGRUBER DISPOSABLE GLOVES, PROCED BRAND, SIZE G (Registro Anvisa: 80256170001).

Manufacturer

TARGA LTDA
  • Source
    ANVSANVISA