Events

Alerta De Seguridad para AccuFlux Elastomeric Infusion Pump

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

¿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
    2012-12-06
  • Fecha de publicación del evento
    2012-12-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121206a.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: medpro accuflux elastomeric infusion pump the united states (us) food and drug administration (fda) issued a class i recall concerning medpro accuflux elastomeric infusion pump, model ct-0020-100h, lot 91209, manufactured by medpro corporation pte ltd, singapore. the recall was initiated because the affected lot may have a higher flow rate than specified. the use of the affected product may lead to over-administration of drug solutions to the patients. the product may fail to meet nominal flow rate of ±15%. for details, please refer to the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id =60030&w=12052012&lang=eng. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 6 december 2012.

Device

AccuFlux Elastomeric Infusion Pump
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medpro AccuFlux Elastomeric Infusion Pump
  • Manufacturer
    Medpro Corporation PTE LTD

Manufacturer

Medpro Corporation PTE LTD
  • Source
    DH