Events

Alerta De Seguridad para HEMODIALIZERS. SERIES A15, A18, A22, (237015, 237018, 237022); AF150, AF180, AF220 (238015, 238018, 238022)

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
    118
  • Fecha
    2001-10-24
  • 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
    The hemodializers were associated with a series of deaths in spain, croatia and the united states. the series has the same types of fibers and were manufactured by althin medical ab, which baxter purchased in march 2000. baxter started a preventive removal through correspondence sent on 24 october 2001. the manufacturer put the alert, and the information on current studies, on the internet http://www.Baxter.Com/customers/products_svcs/renal_therapies/recall/althanerecall.Doc.
  • Acción
    MAKE SURE THAT YOU HAVE RECEIVED THE BAXTER LETTER OF 24 OCTOBER 2001, OR CHECK THE INTERNET HTTP://WWW.BAXTER.COM/CUSTOMERS/PRODUCTS_SVCS/RENAL_THERAPIES/RECALL/ALTHANERECALL.DOC. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. DO NOT USE THESE PRODUCTS! COMMUNICATE WITH YOUR BAXTER REPRESENTATIVE FOR THE AGENDA AND OPERATION OF REPLACING HEMODIALIZERS FROM SERIES TO OTHER BAXTER PRODUCTS. FOR FURTHER INFORMATION, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH BAXTER CONSUMER SERVICE IN THE UNITED STATES BY PHONE 1 (508) 261-8000

Device

HEMODIALIZERS. SERIES A15, A18, A22, (237015, 237018, 237022); AF150, AF180, AF220 (238015, 23801...

Manufacturer

BAXTER INTERNATIONAL, INC.
  • Source
    ANVSANVISA