Events

Alerta De Seguridad para Tendon Stripper, slotted, 5.0 mm I.D. x 12” working length

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

¿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
    2011-07-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110711.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
    Field safety notice: smith & nephew, tendon stripper, slotted, 5.0 mm i.D. x 12” working length it has come to our attention that smith & nephew endoscopy has issued a product recall regarding eleven lots of tendon stripper. according to the local supplier, hong kong is affected. the material of shaft tip (casting) does not meet with the manufacturer’s specification, which could result in rusting of the tendon strippers. this condition could make the device difficult to clean and therefore challenging to adequately sterilize. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Tendon Stripper, slotted, 5.0 mm I.D. x 12” working length
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: [11 Jul 2011] Smith & Nephew, Tendon Stripper, slotted, 5.0 mm I.D. x 12” working length.
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew