Events

Alerta De Seguridad para BD PrepStain™ Vacuum Pumps

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

¿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
    2012-02-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120213.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: bd prepstain™ vacuum pumps medical device manufacturer, bd diagnostics, has issued a field safety notice on all models of bd prepstain™ vacuum pump (all schuco© and knf neuberger models). the manufacturer identified a potential safety hazard that the affected devices exhausts alcohol vapors during normal operation. this could cause a flammable atmosphere if the pump is kept in an enclosed space, such as a cabinet. bd is instructing customers to remove the vacuum pump from any enclosed spaces that are not well ventilated. the local supplier has provided warning label sheets to users for attachment on the affected devices. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

BD PrepStain™ Vacuum Pumps
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BD PrepStain™ Vacuum Pumps
  • Manufacturer
    BD Diagnostics

Manufacturer

BD Diagnostics