Events

Alerta De Seguridad para Sterile Convenience Surgical Packs

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

¿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
    2014-08-26
  • Fecha de publicación del evento
    2014-08-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140826.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: customed sterile convenience surgical packs the united states food and drug administration (fda) has posted a medical device safety alert concerning sterile convenience surgical packs [manufacturing dates: january 9, 2009 to may 19, 2014; distribution dates: january 2009 to may 2014], manufactured by customed, inc. according to the fda, on 3 june, 2014, the manufacturer initiated a recall of sterile convenience surgical packs. the products have been found to have a potential defect due to adhesion. the defect could result in loss of product sterility and lead to infection. users who have the products are advised to stop using the affected product lots. for details, please refer to the following fda website:http://www.Fda.Gov/safety/recalls/ucm411442.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 aug 2014.

Device

Sterile Convenience Surgical Packs
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Customed Sterile Convenience Surgical Packs
  • Manufacturer
    Customed

Manufacturer

Customed