Events

Alerta De Seguridad para DISCHARGEABLE SYRINGE WITHOUT NEEDLE SR - 20 ML, REGISTERED IN ANVISA UNDER NUMBER 80026180002. LOT NO. 833 - D.

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

¿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
    979
  • Fecha
    2009-09-14
  • 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
    The collection started in July / 2009 and the first phase was completed. The company has on its schedule the date of 09/30/2009 to finalize the action. Anvisa is accompanying this collection.
  • Causa
    The company reports that in internal research observed that the symbol of 20 ml syringe without needle of batch 833 / d, presents resistance to handling, differing aspiration and administration of fluids. the product has been developed for use in electrical equipment and not for manual use.
  • Acción
    The recommended actions for the users of the product are as follows: (1) DO NOT USE THE PRODUCT THAT MANUALLY DUE TO THE RESISTANCE OF THE SYMBOL; (2) IDENTIFY THE PRODUCT IN THE STOCK AND SECURE IT FOR REPLACEMENT; (3) IF NECESSARY TO CONTACT THE PRODUCT REPRESENTATIVE OR DISTRIBUTOR: 1. F.CARDOSO E CIA LTDA - BELÉM / PA - (91) 3202 1344 2. FRAMED COM. REPRESENTAÇÕES E SERVIÇOS LTDA - BELÉM / PA - (91) 3236 4086

Device

DISCHARGEABLE SYRINGE WITHOUT NEEDLE SR - 20 ML, REGISTERED IN ANVISA UNDER NUMBER 80026180002. L...

Manufacturer

SALDANHA RODRIGUES LTDA.