Events

Alerte De Sécurité sur Inzii 12/15mm Retrieval System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Applied Medical.

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
    2013-10-28
  • Date de publication de l'événement
    2013-10-28
  • 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_20131028a.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: applied medical inzii 12/15mm retrieval system medical device manufacturer, applied medical, has issued a medical device safety alert concerning inzii 12/15mm retrieval system. the affected model number is cd004 with multiple lot numbers affected. the manufacturer is conducting a voluntary recall of the inzii 12/15mm retrieval system. during shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. the manufacturer is advising users to return affected stock for replacement with unaffected stock. according to the local supplier, the affected products were not distributed in hong kong. for more details, please refer to therapeutic goods administration websitehttp://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01090-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 october 2013.

Device

Inzii 12/15mm Retrieval System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Applied Medical Inzii 12/15mm Retrieval System
  • Manufacturer
    Applied Medical

Manufacturer

Applied Medical