Alerta De Seguridad para GN85 Violet Accelerator Free Nitrile Examination Gloves

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • 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: hpc healthline gn85 violet accelerator free nitrile examination gloves the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning gn85 violet accelerator free nitrile examination gloves, manufactured by hpc healthline. the affected products are manufactured during april 2013. the affected lot numbers are pp003734-326010413 (sizes small, medium, large, extra-large); and pp003781-126010413 (sizes small, medium and large). a primary manufacturing stage fault was detected in the raw material preparation, whereby the anti-ageing chemical addition was insufficient during the production of the two batches above. this has resulted in a thermal reaction initially causing a yellowing cuffs and premature ageing of the cuff area with time. the gloves will continue to radiate heat which is detectable through the packaging. when packed on a pallet the internal cases on the stack hold the heat causing the temperature to rise and ultimately the gloves will start to smoulder and could ignite when exposed to air. the manufacturer has the following recommendations for the affected users: should the cases feel warm to the touch then douse with water and move the cases to an external location away from the building. should the cases show signs of smouldering then again douse with water and contact your local fire service who will help to make the product safe for removal to an external location. if the cases are cool to the touch, quarantine in an external safe location. hpc will conduct a risk assessment and remove the product. if the cases are deemed unsafe to move then disposal shall be arrange at location with a hazardous waste collector. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con297539 if you are in possession of the product, please contact your supplier for necessary actions. posted on 7 august 2013.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: HPC Healthline GN85 Violet Accelerator Free Nitrile Examination Gloves
  • Manufacturer