Events

Alerta De Seguridad para Coiled Tube Infusors

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

¿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
    2013-06-05
  • Fecha de publicación del evento
    2013-06-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130605a.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: baxter healthcare coiled tube infusors medical device manufacturer, baxter healthcare ltd, has issued a medical device safety alert concerning the coiled tube infusors [product codes: 2c1071kjp, 2c1075kjp, 2c1976kj]. the affected products were manufactured between november 2008 through september 2009. due to an increase in complaints for leaks at the distal male luer and luer cap, baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the luer. complaint rates for leaks have since decreased. baxter wants to ensure that no affected product remains in the field. leakage at the connection of the blue winged cap and the distal male luer presents the potential for delay/interruption of therapy and exposure to hazardous solutions. the manufacturer requests users to locate and return the affected products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 jun 2013.

Device

Coiled Tube Infusors
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter Healthcare Coiled Tube Infusors
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd