Events

Alerta De Seguridad para Vascu-Guard Peripheral Vascular Patch

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

¿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
    2015-06-04
  • Fecha de publicación del evento
    2015-06-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150604a.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: baxter vascu-guard peripheral vascular patch the united states food and drug administration (fda) has issued medical device safety alerts concerning vascu-guard peripheral vascular patch. the affected devices are identified as follow:- model numbers: 1504026 vascu-guard ts 1x6cm 1504028 vascu-guard ts 0.8x8cm 1504030 vascu-guard ts 1x10cm 1504032 vascu-guard ts 2x9cm the manufacturer received customer complaints of difficulty in distinguishing the smooth from rough surface of the vascu-guard patch as described in the instructions for use. this is due to a deviation in the surface texture of the vascular patch in a new packaging configuration. the manufacturer is recalling above product codes of its vascu-guard peripheral vascular patch. users can still order this product presented in a plastic jar filled with sterile water and 1% propylene oxide, such configuration is unaffected by this recall. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm449592.Htm http://www.Fda.Gov/safety/recalls/ucm449477.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 june 2015.

Device

Vascu-Guard Peripheral Vascular Patch
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    Medical Device Safety Alert: Baxter Vascu-Guard Peripheral Vascular Patch
  • Manufacturer
    Baxter

Manufacturer

Baxter