Events

Alerta De Seguridad para 5mL Safety Jet Safety Syringe, lot 100120 - registration no. 10369460041

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; Anhui Tiankang Medical 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
    1486
  • Fecha
    2014-12-15
  • 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, there being no risk to consumer health because it is a visible deviation. Should any customer still identify any units in their inventory, please contact the company to arrange for the collection of the product by e-mail sac2@laborimport.com.br or sac@laborimport.com.br
  • Causa
    According to the report of analysis nº 2384.00 / 2014, issued by the adolfo lutz institute, the safety jet 5ml safety syringe product, date of manufacture 01/2010, val 01/2015, lot 100120, was considered unsatisfactory in the aspect test .
  • Acción
    The Sanitary Vigilance of the Municipality of São Paulo determined the interdiction and collection, by means of publication in the Official Gazette of the City of São Paulo on 09/23/2014 page 57, COVISA Communiqué No. 70/2014.

Device

5mL Safety Jet Safety Syringe, lot 100120 - registration no. 10369460041

Manufacturer

Labor Import; Anhui Tiankang Medical Products
  • Source
    ANVSANVISA