Events

Alerta De Seguridad para Swan-Ganz Catheters

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

¿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
    2012-05-30
  • Fecha de publicación del evento
    2012-05-30
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120530.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: edwards swan-ganz catheters medical device manufacturer, edwards lifesciences llc issued a safety alert concerning their swan-ganz catheters with model numbers of ts057hf7, 131f7, 131f7j, 131hf7, 131hf7j, 131hv7j, 141f7, 141hf7, 141hf7j, 151f7 and 151hf7 (manufactured between 9 jan 2012 and 3 may 2012). the above products are now being recalled as users may have difficulties inserting a j-tip guidewire through the distal lumen hub of the catheter. edwards explained that this condition only affects passage of the guidewire when it is being inserted through the distal lumen hub. if the catheter can be placed without guidewire support, it will function and measure pressures as intended. however, the wire will fully advance through the catheter if the back end of the wire is loaded into the distal tip of the catheter. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted 30 may 2012.

Device

Swan-Ganz Catheters
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Edwards Swan-Ganz Catheters
  • Manufacturer
    Edwards Lifesciences LLC

Manufacturer

Edwards Lifesciences LLC