Events

Alerta De Seguridad para Premise Universal Restorative Body Syringe and Unidose, Shade A2

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Kerr 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
    2014-09-12
  • Fecha de publicación del evento
    2014-09-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140912.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: kerr premise universal restorative body syringe and unidose, shade a2 medical device manufacturer, kerr corporation, has issued a medical device safety alert concerning its premise universal restorative body syringe and unidose, shade a2, with the following details: product descriptions: a) refill - syringe premise a2; and b) refill - unidose premise a2 part no.: a)32618; b) 32651 serial no.: a) 4941320; 4946443; 4906963; b) 4908202; 4890805; 4890804; 4890806; 4946447 shipped between june 2013 to november 2013 the manufacturer received some complaints that certain units within certain lots of premise a2 composite may be sticky and/or difficult to use. there is no safety issue associated with using the product. affected users should review to determine if they have any of the affected products in their inventory, and users can choose to return the affected product for replacement if not satisfied. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 sep 2014.

Device

Premise Universal Restorative Body Syringe and Unidose, Shade A2
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Kerr Premise Universal Restorative Body Syringe and Unidose, Shade A2
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation