Events

Alerta De Seguridad para Suction Catheter w/Funnel

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

¿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
    2018-07-05
  • Fecha de publicación del evento
    2018-07-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180705.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: convatec, suction catheter w/funnel medical device manufacturer, convatec, has issued a medical device safety alert concerning its suction catheter w/funnel [product code: icc 502463 (finished pack code 0504218); sap code: 1301774; lot number: 483380, 486850, 493166, 495586, 177896, 176040, 191182, 6l01511, 6l06635, 7b05120, 7b06425, 7f06072, 7l03168, 8d01193]. the manufacturer has voluntarily initiated a global recall of the affected products. testing conducted on the medical device confirmed the potential for a sterile product becoming non-sterile. the affected users are advised to quarantine all affected lots. 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 on5 july 2018.

Device

Suction Catheter w/Funnel
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: ConvaTec, Suction Catheter w/Funnel
  • Manufacturer
    ConvaTec

Manufacturer

ConvaTec