Events

Alerta De Seguridad para (1) A-11, (2) A-15, (3) A (1) A-11, (2) A-15, (3) A -18, (4) A-22, (5) AF-150, (6) AF-180, (7) AF-220, (8) AX-15, (9) AX-22; dialyzer with cellulose acetate fiber series A: (10) Altra Flux, (11) Altra Nova, (12) Altrex, Product codes: (1) 237011, 237311, 237511; (2) 237015, 237315, 237515; (3) 237018, 237318, 237518; (4) 237022; (5) 238015, 238515; (6) 238018, 238518; (7) 238022, 238522; (8) 239015; (9) 239022, 239522; (10 to 12) unidentified; number of lots: (1 to 9) all numbers, (10) 990904P6A1 to 011017P7A, (11) 990924P1D1 to 011019P4A, (12) 990929P6A1 to 000203P6A1; number of catalogs: (1 to 9) unidentified; (10 to 12) 100-416, 100-923, 700-098, 700-150

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

¿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
    385
  • Fecha
    2001-12-07
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    Ecri discussed the current baxter dialysis research on deaths in the united states and abroad. the fda recently issued additional information regarding this correction. in addition to the original models being corrected, baxter is withdrawing its a-11, ax-15 and ax-22 models as a precautionary measure, baxter is redoing the altra flux series a cellulose acetate , altra nova and altrex used in baxter a, af and ax series dialyzers.
  • Acción
    Please verify receipt of the dated letter and response form dated October 18, 2001 from Baxter. Identify and isolate all affected products in your inventory. Baxter recommends that you immediately stop using any of the products mentioned above. Complete and return the response form to the following fax number (847) 270-5457. If you have distributed these dialyzers to other establishments, please send the correction letter and the response form to these units immediately. For more information, contact your local representative and visit http://www.baxter.com/customers/cust_svc/index.html to find links specific to your country. Baxter began corrections by telephone and by letter dated October 18, 2001.

Device

(1) A-11, (2) A-15, (3) A (1) A-11, (2) A-15, (3) A -18, (4) A-22, (5) AF-150, (6) AF-180, (7) AF...

Manufacturer

Baxter International Inc
  • Source
    ANVSANVISA