Events

Alerta De Seguridad para Disposable Hypodermic Syringe 60ml- Laborjet Syringe 60ml, lot 2010-12-15 - registry nº 10369460015.

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

¿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
    1306
  • Fecha
    2013-10-14
  • 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
    According to the manifestation of the company, in compliance with RDC 23/2012, the deviation verified was punctual; in the investigation it was found that a failure occurred in a cutting equipment of the packages and a blade detached from the equipment falling into the package. The company is identifying the units still available for pickup. If a customer still identifies any units in their inventory, please contact the company for arrangements regarding product pick-up.
  • Causa
    According to the report of analysis os 112.298852 / 2013 and proof of analysis of fiscal analysis of single sample, the product disposable hypodermic syringe 60 ml, date of manufacture 15/12/2010, val. 3 years, lot 15-12-2010 was considered unsatisfactory in the aspect assay.
  • Acción
    The Sanitary Vigilance of the State of São Paulo determined the prohibition of commercialization and use, as well as the collection of the product, through publication in the State of São Paulo (DOE) of 08/21/2013 page 43, CVS Communiqué - 08-08-2013

Device

Disposable Hypodermic Syringe 60ml- Laborjet Syringe 60ml, lot 2010-12-15 - registry nº 10369460015.

Manufacturer

Labor Import
  • Source
    ANVSANVISA