Alerta De Seguridad para EXACTAMIX Inlets

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
    2018-05-07
  • 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: baxter healthcare exactamix inlets medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its exactamix inlets, details of product are identified as below: exactamix inlet. non-vented, high-volume inlet; product code: h938173; lot number (corrected expiration date) 802278 (9/2018), 802383 (10/2018), 802385 (5/2018) exactamix inlet. vented, high-volume inlet; product code: h938174; lot number (corrected expiration date): 802279 (8/2018), 802280 (8/2018) exactamix inlet. syringe inlet; product code: h938176; lot number (corrected expiration date) 802286 (9/2018) the manufacturer is issuing a voluntary product recall for the above lots due to incorrectly performed over-labeling. the inlets were over-labeled with a blank label, or with a label containing an extended expiration date. according to the manufacturer, the use of an affected inlet that may have lost its sterility due to being used past its actual expiration date may result in a bloodstream infection or other serious adverse health consequences. the customers are required to locate and remove all affected product lots from their facility. according to the local supplier, there are no serious injury and adverse event reported in hong kong. the affected products are distributed in hong kong between 2 june 2017 and 15 february 2018. if you are in possession of the products, please contact your supplier for necessary actions. updated on 10 may 2018.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter Healthcare EXACTAMIX Inlets
  • Manufacturer

Manufacturer