Events

Alerta De Seguridad para (1) CUSTOM SETS OF THE HEART-LUNG EXTRACORPHORUS PERFUSION UNIT; (2) PERSONALIZED STEREO SETS OF THE HEART-LUNG EXTRACORPHORUS PERFUSION UNIT; (3) STEREO VOLUME LINES OF EXPURGO. Lots: (1) 04F0186, 05F0004, 06F0005, 06F0151, 06F0159, 06F0165, 06F0168, 06F0189, 06F0193, 06F0248, 06F0255, 06F0300, 06F0323, 06F0347, 06F0379, 07F0003, 07F0017, 07F0038, 07F0081, 07F0094, 07F0100 , 07F0185, 08F0006, 08F0006, 08F0018, 08F0036, 08F0082, 08F0194, 08F0194, 08F0194, 08F0253, 08F0256, 08F0258, 08F0265, 08F0288, 08F0346, 08F0348, 08F0375, 08F0386, 09F0002, 09F0117 THROUGH 09F0119, 09F0195, 09F0212, 09F0251, 09F0261 , 09F0265, 09F0265, 09F0266, 09F0266, 09F0269, 10F0011, 10F0290, 10F0294, 10F0323, 10F0328, 10F0341, 10F0353, 10F0362, 10F0264, 10F0264, 10F0260, 10F0276, 10F0286, 10F0212 , 10F0368, 10F0369, 10F0369, 10F0389, 10F0389, 10F0392, 10F0428, 10F0453, 10F0460, 10F0461, 10F0464, 11F0003, 11F0024, 11F0030, 11F0098, 11F0099, 11F0111, 10F0115, 11F0163, 11F0210, 11F0214; (2) 06F0862MP, 08F0827MP, 08F0832MP, 09F0832MP, 09F0850MP, 09F0852MP; (3) 06F0600.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por COBE CARDIOVASCULAR INC. DIV SORIN BIOMEDICAL 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
    57
  • Fecha
    2001-04-27
  • 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 plastic valve of a single direction of the exterior blood line of these sets may break. the manufacturer began a removal for a letter sent on november 6, 2000.
  • Acción
    VERIFY THAT YOU HAVE RECEIVED THE LETTER SENT ON NOVEMBER 6, 2000. IDENTIFY AND ISOLE ANY OF THESE PRODUCTS THAT ARE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT YOUR CARDIOVASCULAR REPRESENTATIVE OR COBE ON PHONE 0021-1-880-221-7943.

Device

(1) CUSTOM SETS OF THE HEART-LUNG EXTRACORPHORUS PERFUSION UNIT; (2) PERSONALIZED STEREO SETS OF ...

Manufacturer

COBE CARDIOVASCULAR INC. DIV SORIN BIOMEDICAL INC
  • Source
    ANVSANVISA