Alerta De Seguridad para Zoo Master Pack 2E 3/16 Hvy Kangaroo

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

¿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
    2012-10-12
  • Fecha de publicación del evento
    2012-10-12
  • 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: ormco zoo master pack 2e 3/16 hvy kangaroo medical device manufacturer, ormco corporation has issued a medical device safety alert concerning zoo master pack 2e 3/16 hvy kangaroo [part no.: 630-0040; lot no.: 061277866]. boxes of zoo pack elastics labeled to contain packages of kangaroo elastics may contain packages of kangaroo and impala elastics. there are no safety or efficacy issues associated with this product. product recall and replacement is ongoing. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 12 october 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ormco Zoo Master Pack 2E 3/16 Hvy Kangaroo
  • Manufacturer

Manufacturer