Events

Alerta De Seguridad para DISPOSABLE HYPODERMIC NEEDLE 30X07mm, lot 080708, Val. 07/2013, registration nº 10369460030.

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
    1214
  • Fecha
    2012-12-14
  • 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 available units are being identified for collection. If a customer still identifies a unit in their inventory, please contact the company to arrange for the product to be collected. #### UPDATE ON 09/30/2013 - The company completed the field action.
  • Causa
    According to fiscal report 397.00 / 2010-ial / sp and proof of analysis of single sample tax, the product disposable hypodermic needle 30x07mm, val. 07/2013, lot 080708 was considered unsatisfactory in the aspect test.
  • 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 Official Gazette of the State of São Paulo (DOE) of 7/7/2012 page 31, CVS Communiqué - 52 of 4/7/2012.

Device

DISPOSABLE HYPODERMIC NEEDLE 30X07mm, lot 080708, Val. 07/2013, registration nº 10369460030.

Manufacturer

Labor Import
  • Source
    ANVSANVISA