Events

Alerta De Seguridad para - Sterile Lemgruber Smooth Surgical Glove (Sizes 6.5, 7.0, 7.5, 8.0 and 8.5) Registration No. 10182420006, Lots: LS007; LS009; LS010; LS012; LS013; LS016; LS023; and - New New Hand Sterile Surgical Glove (Sizes 6.5, 7.0, 7.5, 8.0 and 8.5) Registration No. 10182420004. Lots: NHL014; NHL015; NHL017

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por INDÚSTRIA FRONTlNENSE DE LÁTEX 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
    1417
  • Fecha
    2014-08-13
  • 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 analyzed sample did not meet the certification criterion, being rejected in the dimension test of size 8.5 and impermeability.//// UPDATE 01/15/2016 - The IFBQ reported that it revoked the suspension of the Authorization for the Use of the Conformity Identity Seal after verifying that the company has implemented the proposed corrective actions as well as obtained approval during the tests required by the product regulation.
  • Causa
    Suspension of the authorization for the use of the identification seal by the product certification body (ocp) due to the failure in the dimensional test of size 8.5 and impermeability.
  • Acción
    The company is carrying out Field Action for the collection of products manufactured from the date of the last certification - 04/07/2013.

Device

- Sterile Lemgruber Smooth Surgical Glove (Sizes 6.5, 7.0, 7.5, 8.0 and 8.5) Registration No. 101...

Manufacturer

INDÚSTRIA FRONTlNENSE DE LÁTEX S/A