Events

Alerta De Seguridad para PROCED Gloves Procedures, Registration 80256170001, sizes PP, P, M, G

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

¿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
    1380
  • Fecha
    2014-04-16
  • 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
    The semi-annual maintenance tests indicated that the sample analyzed does not meet the "microbiological" and "orifice verification - impermeability" requirements of INMETRO Ordinance nº332, of June 26, 2012. The health services that have the product in stock should segregate the samples for the record holder to proceed with the collection.////// UPDATE ON 05/29/2014 - The company informs that all the clients have been informed about the collection by means of letter and email and that they are still waiting the return of the answers on the quantity in stock.
  • Causa
    Suspension of the authorization for the use of the identification seal by the product certification body (ocp) due to failure in the bi-annual maintenance tests, according to reports micl / l-241861/1/14, mic in accordance with the present invention, and in the requirement of orifice checking - impermeability, according to the report of test laamh nº000.147 / 14, issued by the ocp.
  • Acción
    Company shall initiate Field Action for the collection of products manufactured from 01/04/2013. All batches manufactured from this date must be collected from the market.

Device

PROCED Gloves Procedures, Registration 80256170001, sizes PP, P, M, G

Manufacturer

TARGA S.A
  • Source
    ANVSANVISA