Alerta De Seguridad para Temporary Cardiac Pacing Wires

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

¿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
    2012-10-19
  • Fecha de publicación del evento
    2012-10-19
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: johnson and johnson temporary cardiac pacing wires medical device manufacturer, johnson & johnson international, has issued a medical device safety alert concerning temporary cardiac pacing wire [product codes.: fep13e and fep15e]. the manufacturer is recalling multiple lots of affected product due to the potential presence of silicone on the blue coating of the stainless steel device. as a precautionary measure, the manufacturer is requesting that users immediately discontinue use of temporary cardiac pacing wire from the following table of product codes and lot numbers: lot number item code dk2ggsp0 fep15e dk2dzzp0 fep15e dk2dpdp0 fep15e dk2ddwp0 fep15e dk2cwmp0 fep13e dk2cmwp0 fep15e dk2cgjp0 fep15e dk2ccgp0 fep13e dk2btlp0 fep13e dk2bddp0 fep13e dj2dpgp0 fep15e according to the local supplier, johnson & johnson (hk) limited, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 october 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Johnson and Johnson Temporary Cardiac Pacing Wires
  • Manufacturer

Manufacturer