Alerta De Seguridad para Sterile Products

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

¿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
    2013-08-19
  • Fecha de publicación del evento
    2013-08-19
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: sterile products from nuvision pharmacy the united states food and drug administration (fda) has issued a press release to remind health care providers about safety concerns with all sterile drug products made and distributed by nuvision pharmacy of dallas, texas. the fda advises that health care providers should not administer any nuvision pharmacy sterile products to patients because the products’ sterility is not assured. if the product marketed as sterile contains microbial contamination, patients could be at risk for serious, potentially life-threatening infections this alert follows the fda’s notice on 18 may 2013 recommending that health care providers and other health care professionals, including hospital staff, immediately check their medical supplies for nuvision pharmacy sterile products, quarantine those products, and not administer them to patients. according to the nuvision pharmacy’s website, injectables using higher strengths of hyaluronic acids in various delivery viscosities have been developed. the company also says that they can formulate products for wrinkle treatment (http://nuvisionpharmacy.Com/?id=13). for details, please visit the following fda website: http://www.Fda.Gov/newsevents/newsroom/pressannouncements/ucm365402.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 august 2013.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Sterile Products from NuVision Pharmacy
  • Manufacturer

Manufacturer