Alerta De Seguridad para Synchro2 Guidewires

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

¿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
    2018-06-13
  • Fecha de publicación del evento
    2018-06-13
  • 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: stryker neurovascular synchro 2 medical device manufacturer, stryker neurovascular, has issued a medical device safety alert concerning its synchro2 guidewires [upn code: m00326010, m00326110, m00326310, m00326320, m00326410, m00326420, m00326510 and m00326520; all lots manufactured from 2 october 2017 to 1 june 2018]. the manufacturer has become aware that the product labels (pouch and carton) for synchro2 products contain an incorrect value in millimeters (0.036mm) for the guidewire outer diameter dimension. the inches dimension (0.014in) on the label is correct. the correct values are 0.014in (0.36mm). 0.036mm represents a typographical error. according to the manufacturer, no adverse health consequences are anticipated. there is no risk to patients associated with previous use of affected devices. hence, no product will be returned as a result of this action. the affected users are requested to take the following actions:- immediately check their internal inventory. review the safety alert and ensure full understanding of the contents. circulate the safety alert internally to all interested/affected parties. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 13 june 2018.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Stryker Neurovascular Synchro 2
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DH