Events

Alerte De Sécurité sur Sterile Chlorohexidine Gluconate/Alcohol Swabs, Sterile Alcohol Swabs and Sterile Povidine Iodine Swabs

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Medical Industries Australia Pty 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
    2013-08-26
  • Date de publication de l'événement
    2013-08-26
  • 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_20130826a.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: sterile chlorohexidine gluconate/alcohol swabs, sterile alcohol swabs and sterile povidine iodine swabs distributed by medical industries australia the therapeutic goods administration (tga), australia posted an medical device safety alert concerning sterile chlorohexidine gluconate/alcohol swabs, sterile alcohol swabs and sterile povidine iodine swabs distributed in the australia by medical industries australia pty ltd., a subsidiary of alpine medical pty ltd. the swabs have been mislabelled sterile and sold on the market. this recall action was carried out prior to approval of the recall strategy by the tga. medical industries australia is requesting wholesalers to return affected stock. for details, please refer to tga websitehttp://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00887-1 if you are in possession of the product, please contact your supplier for necessary actions. posted on 26 august 2013.

Device

Sterile Chlorohexidine Gluconate/Alcohol Swabs, Sterile Alcohol Swabs and Sterile Povidine Iodine...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Sterile Chlorohexidine Gluconate/Alcohol Swabs, Sterile Alcohol Swabs and Sterile Povidine Iodine Swabs distributed by Medical Industries Australia
  • Manufacturer
    Medical Industries Australia Pty Ltd.

Manufacturer

Medical Industries Australia Pty Ltd.