Events

Alerta De Seguridad para Lift Medical Adhesive Remover, 100 ml Bottle

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

¿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
    2013-07-17
  • Fecha de publicación del evento
    2013-07-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130717.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: opus healthcare lift medical adhesive remover, 100 ml bottle the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning lift medical adhesive remover, 100 ml, manufactured by opus healthcare, a division of alliance pharmaceuticals limited. the affected products have product code of 5501, batch code of m364 and expiry date of sep 2015. opus healthcare is withdrawing the affected products following an observation of a “cloudy solution” of the lift medical adhesive remover which has subsequently been attributed to microbial contamination. according to opus healthcare, there is little risk to the health of healthy individuals; however there may be a small risk of opportunistic infection developing in those whose immune systems are compromised due to illness or therapies. therefore, regardless of the appearance of the product from the affected batch, all bottles of the affected batch need to be returned. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con287037 if you are in possession of the product, please contact your supplier for necessary actions. posted on 17 july 2013.

Device

Lift Medical Adhesive Remover, 100 ml Bottle
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Opus Healthcare Lift Medical Adhesive Remover, 100 ml Bottle
  • Manufacturer
    Opus Healthcare

Manufacturer

Opus Healthcare