Events

Alerta De Seguridad para 3M ESPE IMPRINT II Regular Body VPS Impression Material Refill

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por 3M ESPE Dental Products.

¿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
    2013-12-04
  • Fecha de publicación del evento
    2013-12-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131204.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: 3m espe imprint ii regular body vps impression material refill medical device manufacturer, 3m espe dental products, has issued a medical device safety alert concerning its imprint ii regular body vps impression material refill 4-pack [catalogue number: 9379; lot number: n510884 and n510889]. the manufacturer is conducting a voluntary recall of the above affected products. the reason for the recall of this product is that the moisture displacement feature is greatly reduced, which may impact the quality of a dental impression. the manufacturer will arrange for return and replacement of affected products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 december 2013.

Device

3M ESPE IMPRINT II Regular Body VPS Impression Material Refill
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: 3M ESPE IMPRINT II Regular Body VPS Impression Material Refill
  • Manufacturer
    3M ESPE Dental Products

Manufacturer

3M ESPE Dental Products