Events

Alerta De Seguridad para GOPump Elastomeric Infusion PumpKit

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

¿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
    2013-03-19
  • Fecha de publicación del evento
    2013-03-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130319.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: symbios gopump elastomeric infusion pumpkit the united states food and drug administration (fda) has issued a medical device safety alert concerning gopump elastomeric infusion pumpkit manufactured by symbios medical products, llc. the affected kits, with or without accessories, are all containing dual gopump, part number 510076. these kits were distributed between 10 september 2012 and 11 february 2013. according to the manufacturer, the products are being recalled as the flow restrictor bead may become displaced from its fitting which may permit solutions to flow at a higher rate than intended. this product may cause serious adverse health consequences, including death. the manufacturer advises the affected users to immediately remove all affected gopump kits from the inventory. for details, please visit the following fda websites: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm344311.Htm http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm344352.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 march 2013.

Device

GOPump Elastomeric Infusion PumpKit

Manufacturer

Symbios Medical Products
  • Source
    DH