Events

Alerta De Seguridad para Uromatic Tur Administration Set

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

¿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
    2016-01-14
  • Fecha de publicación del evento
    2016-01-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160114.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 uromatic tur administration set medical device manufacturer, baxter healthcare has issued a medical device safety alert concerning uromatic tur administration set. [product code: emc4015n; lot numbers: 14i01v842m, 14j30v283 and 14k03v521] the manufacturer has issued a recall for the above referenced lots due to complaints received related to the disconnection of the spike from the tubing of the set. according to the manufacturer, the most likely hazard resulting from this issue is delay / interruption of therapy. however, disconnections also have the potential to lead to microbial contamination of the fluid path and hence contamination of the surgical field. the manufacturer has not received any reports of adverse event or patient injury related to this issue. according to the local supplier, the affected products are distributed in hong kong. product recall in ongoing. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 january 2016.

Device

Uromatic Tur Administration Set
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter Healthcare Uromatic Tur Administration Set
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare