Events

Alerta De Seguridad para ENDOPATH Probe Plus ll Shafts

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

¿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
    2013-04-26
  • Fecha de publicación del evento
    2013-04-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130426b.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: ethicon endopath probe plus ll shafts medical device manufacturer, ethicon, has issued a field safety notice concerning endopath probe plus ll shafts. the affected code numbers are eps01-eps08 (with expiration dates from september 2015 through and including march 2018) and eps10-eps13 (with expiration dates from april 2013 through and including march 2018). the manufacturer is initiating a voluntary recall for endopath probe plus ll shafts because the possibility that a tear in the tyvek packaging may compromise the sterility of the device such that we could no longer assure the stated sterility levels are met for our product. the endopath probe plus ll shaft is sold and labeled as “sterile”. this voluntary recall does not apply to the endopath probe plus ii handles. product recall is on-going. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 april 2013.

Device

ENDOPATH Probe Plus ll Shafts
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ethicon ENDOPATH Probe Plus ll Shafts
  • Manufacturer
    Ethicon

Manufacturer

Ethicon