Events

Alerte De Sécurité sur 5/10/12mm Armoured Swing-top

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Surgical Innovations 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
    2017-09-19
  • Date de publication de l'événement
    2017-09-19
  • 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_20170919a.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: surgical innovations ltd 5/10/12mm armoured swing-top medical device manufacturer, surgical innovations ltd, has issued a medical device safety alert concerning its instrument, 5/10/12mm armoured swing-top [part number: ya512stsa; lot number: 703340]. there is a labelling error on the above-mentioned product. the devices are sterile, however the label states non-sterile. in particular, the label on the device (primary packaging) is labelled incorrectly and states “non-sterile”. the label on the carton (secondary packaging) is correct and states “sterile”. according to the manufacturer, this does not impact the quality of the product, the product is sterile and there is no risk to patient safety. a steri-dot is applied to each primary and secondary packaging to indicate the batch has been sterilised. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 september 2017.

Device

5/10/12mm Armoured Swing-top
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Surgical Innovations Ltd 5/10/12mm Armoured Swing-top
  • Manufacturer
    Surgical Innovations Ltd

Manufacturer

Surgical Innovations Ltd