Events

Alerta De Seguridad para GUIDE TO TEFLONATE ANGIOPLASTY 0.035 "X 150 CM JET BIOMETRIX, Model HR-3823. ANVISA Registration No. 10332200028. Lot under risk: I8119.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BIOMETRIX LTD (ISRAEL).; EPTCA Medical Devices Ltda..

¿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
    1335
  • Fecha
    2013-12-11
  • 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 information presented by EPTCA Ltda, packaging was evidenced without the heat seal, which exposes the product to the environment and, consequently, compromises its sterility.
  • Causa
    Possible absence of heat seal in the primary packaging of the product, leading to the loss of the guarantee of its sterilization.
  • Acción
    The product is being collected by the registration holder in Brazil. Identify in your stock and in the stocks of your customers (in the case of distributors) products under risk, verifying the integrity of the packaging sealing of all units of the product in question. Once defective products have been identified, segregate them to avoid inadvertent use. Please contact the record holder or your distributors for return purposes.

Device

GUIDE TO TEFLONATE ANGIOPLASTY 0.035 "X 150 CM JET BIOMETRIX, Model HR-3823. ANVISA Registration ...

Manufacturer

BIOMETRIX LTD (ISRAEL).; EPTCA Medical Devices Ltda.
  • Source
    ANVSANVISA