Events

Alerta De Seguridad para Horizons International TWISTER PLUS Rotatable Retrieval Device

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

¿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
    2013-11-22
  • Fecha de publicación del evento
    2013-11-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131122.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: horizons international twister plus rotatable retrieval device boston scientific, as the distributor of the twister plus rotatable retrieval device initiated a recall of the device in coordination with horizons international corporation which is the manufacturer of the device. the affected catalogue number, material number and lots/batches as follows: twister plus rotatable retrieval device - 22mm (box of 1) : catalogue number 6141, material number m00561410, lot/batch number h13061101, h13062403, h13062404, h13071301 twister plus rotatable retrieval device - 22mm (box of 5) : catalogue number 6141, material number m00561411, lot/batch number h13061101, h13062403, h13062404, h13071301 twister plus rotatable retrieval device - 22mm (box of 10): catalogue number 6141, material number m00561412, lot/batch number h13061101, h13062403, h13062404, h13071301 twister plus rotatable retrieval device - 26mm (box of 1): catalogue number 6142, material number m00561420, lot/batch number h13061102, h13061103, h13061104, h13062401, h13062402, h13071302, h13082603 twister plus rotatable retrieval device - 26mm (box of 5): catalogue number 6142, material number m00561421, lot/batch number h13061102, h13061103, h13061104, h13062401, h13082603 twister plus rotatable retrieval device - 26mm (box of 10): catalogue number 6142, material number m00561422, lot/batch number h13061102, h13061104, h13062401, h13062402, h13071302, h13082603 it has come to the attention of boston scientific that the packages of certain lots/batches of twister plus may not be fully sealed, affecting the sterility of the device. use of a retrieval device from a package with an open seal may impart a patient risk of infection. the manufacturer is advising customers to identify any product from the affected lots/batches within their inventory, segregate the affected product immediately and return it to boston scientific. 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 22 november 2013.

Device

Horizons International TWISTER PLUS Rotatable Retrieval Device
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Horizons International TWISTER PLUS Rotatable Retrieval Device
  • Manufacturer
    Boston Scientific / Horizons

Manufacturer

Boston Scientific / Horizons