Alerta De Seguridad para LANCETAS SFL YELLOW 2.2X1.0mm - MICROTAINER BRAND SAFETY FLOW LANCETS BDLANCETA MICROTRAINER. II - MEDIUM RISK, Reg. ANVISA: 10033430270 - Lots: 2319394, 3069725, 3149410 and 3213535.

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

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    Upon failure of the anti-reuse device, the lancet blade may be exposed during disposal. Note: manufacture of this product was discontinued in 2003. The last sale in Brazil occurred in 2004 and the registration of the product with ANVISA was valid until the year 2005. The product in question is not intended for home users, only hospitals and clinics According to the company there were no reported problems with the lots involved in Brazil and that the collection of this product 3 years after the closure of sales is preventive. For further information contact the BD Technical Center, through the Telephone. 0800.055.5654.// Update: On January 23, 2008 the company reported that 38 customers received the product and that all were informed of the recall, of which 24 stated they did not have any unit of the lots involved in stock. They also reported that this recall was released in the media (newspaper, radio and television) in November 2007.
  • Causa
    Limited number of reports of device-trigger device crash. access the lots: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2007/896.Pdf.
  • Acción
    Voluntary pickup with mailing for all customers requesting that the use of the product be interrupted and the remaining quantities are returned to the company.


  • Source