Alerta De Seguridad para Braunoderm disinfectant solution

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

¿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
  • 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
    Press release
  • Causa
    Recall of braunoderm disinfectant solution the department of health (dh) today (may 23) endorsed the voluntary recall of three batches of "braunoderm" iodine solution by its german manufacturer b. braun medical ag as less than the specified amount of the active ingredient, iodine was detected in the products through ongoing in-house monitoring. dh is notified of the move by the product's local supplier, united base (hong kong) ltd. the latter reports that regular stability analysis by the product manufacturer reveals that the level of available iodine in some batches falls slightly under the shelf-life specification before the expiry date is reached. the exact details of the three batches under global recall are - a) braunoderm ungef variofl 'de' 1000ml (article no.: 3881156, batch no.: 0253m14) b) braunoderm ungef spruehfl 'de' 250ml (article no.: 3881105, batch no.: 0253m14) c) braunoderm ungef spruehfl 'de' 1000ml (article no.: 3881105, batch no.: 0103m11) in hong kong, only (b) has been imported by united base for distribution to public and private hospitals, dialysis centres and nursing home. "although b braun assesses that the effectiveness of the disinfectant is unlikely to be compromised as the insufficiency is only marginal, to be prudent, dh endorses the recall, especially as we understand that in hong kong, the product is also used by hospitals and dialysis centres to disinfect haemodialysis equipment besides for skin disinfection," a dh spokesman remarks. "given that renal patients are chronically ill and often also immune-compromised, their safety cannot be overlooked," the spokesman supplements. it is reassuring that so far, dh has not received any report of adverse event related to the affected product. all healthcare institutions which have received the affected product have been approached by united base for the recall. united base (hong kong) ltd. has also set up hotlines 2959 6138 or 9859 0231 to answer related enquiries. the spokesman urges individual customers and healthcare providers who still have the affected disinfectant in hand to stop using it immediately and to choose substitutes from alternatives available on the market. he reaffirms that dh will continue its investigation, closely monitor the recall and seek legal advice for suspicion of any breach of the law. ends.


  • Modelo / Serial
  • Descripción del producto
    Press release: Recall of Braunoderm disinfectant solution
  • Manufacturer