Events

Alerta De Seguridad para SUREFLUX 25UX LC GA

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Nipro Europe 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
  • Fecha
    2015-08-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150804_b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: nipro europe nv sureflux 25ux lc ga medicines and healthcare products regulatory agency (mhra), united kingdom, has posted a field safety notice concerning sureflux 25ux lc ga [lot numbers: 14i29f, 14l29f, 15b23f, 14i29f], a dialyzer manufactured by nipro europe v. the manufacturer received complaints from the japanese market regarding a housing body crack of dialyzer and a leakage of the saline or dialyzer solution. the position of the crack is near its header position. the manufacturer found that the housings were misaligned because auxiliaries were bumped unintentionally into auxiliary removing device set before roughly-cutting process. due to this, misaligned housings were contacted by holding jig at the next process and cracks were generated around the dialysate ports. according to the manufacturer, there was no adverse event or health injury related to this problem having been reported so far. the manufacturer is recalling the affected product and users are advised not to use the affected lots. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

SUREFLUX 25UX LC GA
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Nipro Europe NV SUREFLUX 25UX LC GA
  • Manufacturer
    Nipro Europe V

Manufacturer

Nipro Europe V