Events

Alerta De Seguridad para Irrigation Tray: (1) Bardia, (2) Bulb, (3) Gent-L-Kare with 60cc Bulb Syringe. Catalog #: (1) 802050, (2) 750170, (3) 4092; Lot #: (1 and 2) all numbers, (3) batches starting with MF, MH, N, P, R, S, T and U.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Premium Plastics Inc, Bard Medical Div C R Bard 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
    398
  • Fecha
    2002-02-22
  • 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
    In the tray above, the package can be damaged, compromising the sterility of the syringe kits. the manufacturer initiated withdrawal by letter on 16 november 2001.
  • Acción
    Make sure you received the letter dated November 16, 2001 from Premium Plastics. Identify and isolate any affected product in your inventory. For more information, contact Premium Plastics by phone at (312)255-8700 or your local Premium Plastics representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

Irrigation Tray: (1) Bardia, (2) Bulb, (3) Gent-L-Kare with 60cc Bulb Syringe. Catalog #: (1) 802...

Manufacturer

Premium Plastics Inc, Bard Medical Div C R Bard Inc
  • Source
    ANVSANVISA