Events

Alerta De Seguridad para (1) Sets of 2-pieces composed of 2 Splines and 1 pump, (2) Sets of 3 parts, composed of 3 Branches and 1 pump, (3) Spare Pumps .. Catalog No. .: (1) 013490, (2) 013463, (3) 013467; Lots Nos .: (1) LLF246, LLG320; (2) LLF246; (3) Unidentified

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

¿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
    239
  • Fecha
    2000-12-22
  • 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
    Some defective pumps have been included in the mentioned talas assemblies or sent as replacement pumps for replacement. the factory initiated a removal by letter dated august 23 and august 24, 2000.
  • Acción
    Make sure you have received the letter dated August 23 or 24, 2000 from Cramer Products. Identify and isolate any defective product from your inventory. For more information, contact your local representative or directly with Cramer Products. Clarification: The factory stated that 341 damaged pumps were returned

Device

(1) Sets of 2-pieces composed of 2 Splines and 1 pump, (2) Sets of 3 parts, composed of 3 Branche...

Manufacturer

Cramer Products
  • Source
    ANVSANVISA