Events

Alerta De Seguridad para ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight

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
    2015-05-05
  • Fecha de publicación del evento
    2015-05-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150505a.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: smith & nephew ultra fast-fix knot pusher/suture cutter, straight medical device manufacturer, smith & nephew, inc., has issued a medical device safety alert concerning ultra fast-fix knot pusher/suture cutter, straight. [product number: 72201537; batch number: all batches manufactured from april 2010 to april 2014 which have corresponding expiration dates of april 2015 to april 2019]. the manufacturer’s internal investigation has found that the packaging material and design to be insufficient to prevent the ultra fast-fix knot pusher suture cutter’s sharp edges from potentially puncturing the pouch and rendering the device unsterile. an unsterile device used during an arthroscopic repair could potentially lead to a post-operative infection. product recall is ongoing. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 may 2015.

Device

ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Smith & Nephew ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew