Events

Alerta De Seguridad para Disposable Resuscitators

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

¿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
    2012-05-15
  • Fecha de publicación del evento
    2012-05-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120515.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: bomimed. disposable resuscitators the health canada (hc) posted a recall notice concerning disposable resuscitators manufactured by bomimed, inc. according to the manufacturer, during in-house testing, it was discovered that if the maks were squeezed too hard, the plastic shell could crack, resulting in the inability of the mask to ventilate. for details, please refer to hc website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted 15 may 2012.

Device

Disposable Resuscitators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BOMImed. Disposable Resuscitators
  • Manufacturer
    BOMImed

Manufacturer

BOMImed