Events

Alerta De Seguridad para Human Blood Vessel for Transplantation: (1) Model A020 ​​Descending thoracic aorta, (2) Model P010 Pulmonary Trunk patch, (3) Model PH00 Hemiartéria Pulmonar. Nos. Series: (1) 6489451, (2) 6489486, (3) 6489478

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por CryoLife 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
    276
  • Fecha
    2002-01-25
  • 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 above mentioned vessels, for transplantation, were collected from a donor that was not properly evaluated. the manufacturer initiated a correction by letter dated 1st. november 2001. the firm did not give any information to ecri.
  • Acción
    Make sure you received the letter dated November 1, 2001 from CryoLife. Identify and isolate any affected product in your inventory. For more information, contact CryoLife by phone at (800)438-8285.

Device

Human Blood Vessel for Transplantation: (1) Model A020 ​​Descending thoracic aorta, (2) Model P01...

Manufacturer

CryoLife Inc
  • Source
    ANVSANVISA