Events

Alerte De Sécurité sur Ultrasound Gel

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Yafho Bio-Technology Co Ltd; and/or Linmed Medical Co Ltd..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-05-16
  • Date de publication de l'événement
    2017-05-16
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170516.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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