Events

Alerta De Seguridad para Ultrasound Gel

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Yafho Bio-Technology Co Ltd; and/or Linmed Medical Co Ltd..

¿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
    2017-05-16
  • Fecha de publicación del evento
    2017-05-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170516.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: meditech ultrasound gel the therapeutic goods administration (tga) of australia has issued a medical device safety alert concerning ultrasound probe cover (telescopic folded with gel); and all products labelled meditech and manufactured by: yafho bio-technology co ltd; and/or linmed medical co ltd. [part number/ order code: 88654012; lot number: 201701]. meditech systems asia pacific has become aware that the product ultrasound probe cover (telescopic folded with gel) may be contaminated with burkholderia cenocepacia. whilst no other batches or pack sizes of this product have been supplied by meditech, users are further advised that all products labelled meditech and manufactured by: yafho bio-technology co ltd; and/or linmed medical co ltd. are also affected by this recall. users are advised that all product labelled meditech and manufactured by yafho bio-technology co ltd and/or linmed medical co ltd, including all stock of ultrasound probe cover (telescopic folded with gel) should quarantined immediately and recalled from the market. for details, please refer to the tga websites: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2017-rn-00631-1 https://www.Tga.Gov.Au/alert/meditech-ultrasound-gel if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 may 2017.

Device

Ultrasound Gel

Manufacturer

Yafho Bio-Technology Co Ltd; and/or Linmed Medical Co Ltd.
  • Source
    DH