Events

Alerte De Sécurité sur ExoSeal Vascular Closure Device

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

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
    2012-11-01
  • Date de publication de l'événement
    2012-11-01
  • 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_20121101.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: cordis exoseal vascular closure device medical device manufacturer, cordis corporation (a johnson & johnson company), has issued a field safety notice concerning exoseal vascular closure device. the affected catalogue numbers were ex500ce, ex600ce and ex700ce and affected lot numbers ranged from 15466779 to 15682751. expiration dates of the affected products range from july 2013 through july 2014. cordis recently identified that the affected lots of cordis exoseal vascular closure device were sterilized using a process that did not achieve the sterility assurance level that is required by the standards for this class of product. the discrepancy was detected as part of routine quality control testing. according to manufacturer, no complaints have been reported to date that are related to this issue, and there is no significant increased risk of infection to the patient from exposure to the affected products. therefore, there is no concern for patients who have already been treated with the device and no additional patient follow-up is required. according to the local supplier, johnson & johnson (hk) limited, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 november 2012.

Device

ExoSeal Vascular Closure Device
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cordis ExoSeal Vascular Closure Device
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation