Events

Alerta De Seguridad para Custom Dialysis Trays/Kits

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

¿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
    2011-09-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110920.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
    Fda class i recall: lee medical international inc., custom dialysis trays/kits u.S. food and drug administration (fda) has issued a class i recall concerning custom dialysis trays/kits manufactured by lee medical international inc. the custom dialysis kits are designed to include all the components (gloves, bandages, fistula needles, antibacterial pads [povidone iodine (pvp) prep pads], and specific bloodlines) used in preparing hemodialysis vascular access sites for patients undergoing dialysis procedures. the pvp prep pads were recalled by h & p industries because the pads may not be sterile. patients receiving hemodialysis who use the pads may be at potential risk for serious or life threatening infection. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/ucm272167.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Custom Dialysis Trays/Kits

Manufacturer

Lee Medical International Inc