Alerta De Seguridad para SWAB STEM PLASTIC WITH STUART, Registration nº 10369460050, lot 20110312 Manufacture 12/03/2011, Validity 12/03/2016 and lot 20110814 Manufacture 14/05/2011, Validity 8/14/2016

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Labor Import.

¿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
    1207
  • Fecha
    2012-11-30
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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 the use of the product with quality deviation can lead to the result of altered biological culture. In compliance with RDC 23/2012, the company also informs that the available units were identified, collected and destroyed on 09/09/2012. If a customer still identifies a unit in their inventory, please contact the company to arrange for the product to be collected by e-mail sac@laborimport.com.br or telephone (11) 4197-5980. //// UPDATE 10/01/2014 - The company submitted a form finalizing the field action, considering that there was no further contact of customers for the return of the product since February 2013.
  • Causa
    The product presented an unsatisfactory result regarding the appearance and sterility tests, according to the report of analysis nº 981.Cp / 2012, for lot 20110312, manufacture 12/03/2011, validity 03/12/2016 and report of analysis 980.00 / 2012, for lot 20110814 manufacture 14/05/2011, validity 08/14/2016, issued by the instituto adolfo lutz.
  • Acción
    The Sanitary Surveillance of the Municipality of São Paulo determined the definitive ban on affected lots, through the publication in the Official Gazette of the City of São Paulo (DOC), Comunicados COVISA no. 029/2012 and Notice COVISA Nº. 34/2012, of 07/28/2012 and 08/08/2012, respectively.

Manufacturer

  • Source
    ANVSANVISA