Events

Alerta De Seguridad para SERFAS ENERGY NO SUCTION. Registro Anvisa n ° 80005430132. Product model: CODE 0279350101 - PONTEIRA SERFAS ENERGY 3,5MM 90 DEGREES. Affected lots: 13128AE2 to 14337AE2.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Stryker do Brasil Ltda.; Stryker Endoscopy.

¿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
    1647
  • Fecha
    2015-07-28
  • 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
    Check your stock and segregate the products at risk as soon as possible, avoiding their use. Send Stryker the CUSTOMER RESPONSE form provided by the company.
  • Causa
    There is a potential risk of the probes related to the above mentioned batches rupturing and releasing fragments into the joint space, and an eventual need for immediate surgical intervention to remove the fragments may arise. in addition, there is a potential risk of the fragments remaining within the joint space, which may result in a compromise of function.
  • Acción
    Product pickup.

Device

SERFAS ENERGY NO SUCTION. Registro Anvisa n ° 80005430132. Product model: CODE 0279350101 - PONTE...

Manufacturer

Stryker do Brasil Ltda.; Stryker Endoscopy
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    ANVSANVISA