Events

Alerta De Seguridad para Roadrunner Uniglide Hydrophilic Wire Guide

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Cook Medical.

¿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
    2016-07-07
  • Fecha de publicación del evento
    2016-07-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160707b.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: cook medical roadrunner uniglide hydrophilic wire guide health canada has posted a medical device safety alert concerning roadrunner uniglide hydrophilic wire guide [model number: hpw-35-150, hpwa-35-180, hpwas-35-180], manufactured by cook medical. the manufacturer is initiating a voluntary recall because of a potential coating contamination. the supplier of the coating, dsm biomedical b.V., has recalled some of its coating material because of concerns about potential component contamination with glass particles. the reported glass particle size ranged from approximately 4 to 280 micrometre. for details, please refer to the health canada website: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59208r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 july 2016.

Device

Roadrunner Uniglide Hydrophilic Wire Guide
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    Medical Device Safety Alert: Cook Medical Roadrunner Uniglide Hydrophilic Wire Guide
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical