Events

Alerta De Seguridad para Coseal Surgical Sealant

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
    2011-07-27
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110727.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
    Alert on product recall: coseal surgical sealant baxter healthcare ltd is voluntarily recalling one lot of coseal surgical sealant (product code: 934074, lot no. ha090947, with expiry date 08/31/11) as a precautionary measure. one parameter of the device in the manufacturer’s stability test is found to be out of specification and there is possible failure for the product to gel appropriately. the manufacturer claimed that such failure does not represent risk for patient’s life. the manufacturer further asked the users to stop using the above lots and to quarantine any units that may be put in the users’ inventory. if the product cannot gel appropriately, users may use of a second kit of product or alternative method for hemostasis. the measures have been described in the ifu of the device. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Coseal Surgical Sealant
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: [27 Jul 2011] Coseal Surgical Sealant
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd