Alerta De Seguridad para URINE SOLIDOR COLLECTOR - Record 10237580033 - Lots Affected 1203B and 1235A.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por LAMEDID COMERCIAL E SERVICOS 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
    1155
  • Fecha
    2012-07-26
  • 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
    Anvisa follows this action. See RESOLUTION - RE Nº 3.172, OF JULY 25, 2012. (Attached). #### UPDATE - 01/11/2012 - CLOSURE - The company sends file 0890363 / 12-3, announcing the closure of the field action. #### UPDATE - 04/16/2013 - The company forwards the certificate of destruction of the products collected through file 0218488 / 13-5. ###
  • Causa
    Anvisa by means of resolution - re nº 3,172, of july 25, 2012, in its article 2, determines the collection of the aforementioned lots, considering tax report 1568.00 / 2012 which establishes that lot 1203b of the collector product adult urine presents a quality deviation from the appearance test because it shows small dark stains along the extension tube and dirt inside the emptying tube and considering the fiscal analysis report 1569.00 / 2012 which establishes that lot 1235a of the product adult filter urine collector shows quality deviation for the appearance assay because it has small dark stains along the extension hose and dirt inside the drain tube.
  • Acción
    Check for this product in stock. Segregate in a safe place for later recall and destruction.

Manufacturer