Alerta De Seguridad para Disposable Hypodermic Syringe Safety 3ml, lot 101208 - registration # 10369460028

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; Shandong Weigao Group Medical Polymer Co..

¿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
    1579
  • Fecha
    2015-05-15
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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 diversion verified was punctual, there being no risks to the health of the consumer as a visible deviation. If any customer still identifies any units in their inventory, please contact the company to arrange the collection of the product through the e-mail quality@laborimport.com.br
  • Causa
    According to the report of analysis nº 277.00 / 2015, issued by the instituto adolfo lutz, the product disposable hypodermic safety syringe 3ml, safety jet brand, date of manufacture 12/2010, val. 12/2015, lot 101208, was considered unsatisfactory in the aspect assay.
  • 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 of 04/11/2015, page 53, COVISA Communiqué Nº. 018/2015