Events

Alerta De Seguridad para Continuum Pump and Tubing Set

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

¿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
    2012-04-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120425.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
    Field safety notice: medrad® continuum pump and tubing set medical device manufacturer, medrad, inc. has initiated a field safety corrective actions concerning medrad® continuum pump and tubing set [catalogue numbers: mik 200a, mil 200b, 3009135, 3015550, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159 and 3015161]. the recall is initiated because the tubing exhibits a variation that, when used in conjunction with any continuum pump, may result in flow rate accuracy performance issues. in addition, the manufacturer is also recalling the continuum pumps, calibrated using the tubing associated with this recall. for those serial numbers not affected by this recall, users are advised to follow the instructions enclosed to reset the maximum flow rate of their continuum pump(s) for future operation with the new tubing. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Continuum Pump and Tubing Set
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: MEDRAD® Continuum Pump and Tubing Set
  • Manufacturer
    MEDRAD

Manufacturer

MEDRAD
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    DH