Events

Alerta De Seguridad para Universal Flex2 Breathing Circuit

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

¿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
    2013-10-24
  • Fecha de publicación del evento
    2013-10-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131024a.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: king systems universal flex2 breathing circuit the united states food and drug administration (fda) has issued a medical device safety alert concerning universal flex2 breathing circuit [part no.: df4110-61; lot no.: i063n], manufactured by king systems corporation. the manufacturer received a customer complaint indicating that the customer had ordered a breathing circuit with a latex breathing bag. the product they received contained a latex breathing bag, but was labeled as non-latex. http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-2272-2013&w=10092013&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 october 2013.

Device

Universal Flex2 Breathing Circuit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: King Systems Universal Flex2 Breathing Circuit
  • Manufacturer
    King Systems Corporation

Manufacturer

King Systems Corporation