Events

Alerta De Seguridad para Product trade name: STERILE HYPODERMIC SYRINGE FOR SINGLE USE WITH NEEDLE DL /// Registration number: 80511919003 /// Affected model: 3 and 5 mL /// affected lot: 1408-05 and 1408- 01 / / Product hazard class: II

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por DLP MEDICAL DO BRASIL INDÚSTRIA E COMÉRCIO LTDA.; DL MÉDICA S.A DE C.V.

¿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
    1884
  • Fecha
    2016-05-06
  • 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
    In case of remaining stock, inform the company and carry out its guidelines.
  • Causa
    The various non-conformities indicated by the reports that led to the suspension of the quality certificate could pose a risk to users, by which, as soon as we become aware./// recommendation: immediately suspend the sale of the products as well as their use.
  • Acción
    Risk classification: II /// Classification of the field action: recollection with subsequent destruction /// Field action code: not specified /// Recommendations to users and patients: suspension of distribution, commercialization and use of lots involved.

Device

Product trade name: STERILE HYPODERMIC SYRINGE FOR SINGLE USE WITH NEEDLE DL /// Registration num...

Manufacturer

DLP MEDICAL DO BRASIL INDÚSTRIA E COMÉRCIO LTDA.; DL MÉDICA S.A DE C.V
  • Source
    ANVSANVISA