Events

Alerta De Seguridad para Ultraxx Nephrostomy Balloon Set and Ascend AQ Ureteral Dilation Balloon Catheter Set

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

¿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
    2016-02-03
  • Fecha de publicación del evento
    2016-02-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160203.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: cook medical ultraxx nephrostomy balloon set and ascend aq ureteral dilation balloon catheter set medical device manufacturer, cook medical, has issued a medical device safety alert concerning its ultraxx nephrostomy balloon set and the ascend aq ureteral dilation balloon catheter set [catalogue number: unbs-10-15-cs (lot number: 5082013) and aubs-6-4 (lot number: 5083854)]. the affected products were distributed between 22 july 2014 and 6 august 2014. the manufacturer has received reports of packages labeled as ultraxx nephrostomy balloon set actually containing the ascend aq ureteral dilation balloon catheter set and vice versa. according to the manufacturer, this event is not likely to lead to an adverse patient/user outcome and is obvious to the user. this nonconformity is detectable, making it less likely that an incorrect device would be used or misused during a procedure. product recall is on-going. 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 3 february 2016.

Device

Ultraxx Nephrostomy Balloon Set and Ascend AQ Ureteral Dilation Balloon Catheter Set
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Cook Medical Ultraxx Nephrostomy Balloon Set and Ascend AQ Ureteral Dilation Balloon Catheter Set
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical