Events

Alerta De Seguridad para Inzii 12/15mm Retrieval System

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

¿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
    2013-10-28
  • Fecha de publicación del evento
    2013-10-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131028a.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: applied medical inzii 12/15mm retrieval system medical device manufacturer, applied medical, has issued a medical device safety alert concerning inzii 12/15mm retrieval system. the affected model number is cd004 with multiple lot numbers affected. the manufacturer is conducting a voluntary recall of the inzii 12/15mm retrieval system. during shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. the manufacturer is advising users to return affected stock for replacement with unaffected stock. according to the local supplier, the affected products were not distributed in hong kong. for more details, please refer to therapeutic goods administration websitehttp://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01090-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 october 2013.

Device

Inzii 12/15mm Retrieval System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Applied Medical Inzii 12/15mm Retrieval System
  • Manufacturer
    Applied Medical

Manufacturer

Applied Medical