Events

Alerte De Sécurité sur Sterile Convenience Surgical Packs

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

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
    2014-08-26
  • Date de publication de l'événement
    2014-08-26
  • 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_20140826.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: customed sterile convenience surgical packs the united states food and drug administration (fda) has posted a medical device safety alert concerning sterile convenience surgical packs [manufacturing dates: january 9, 2009 to may 19, 2014; distribution dates: january 2009 to may 2014], manufactured by customed, inc. according to the fda, on 3 june, 2014, the manufacturer initiated a recall of sterile convenience surgical packs. the products have been found to have a potential defect due to adhesion. the defect could result in loss of product sterility and lead to infection. users who have the products are advised to stop using the affected product lots. for details, please refer to the following fda website:http://www.Fda.Gov/safety/recalls/ucm411442.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 aug 2014.

Device

Sterile Convenience Surgical Packs
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Customed Sterile Convenience Surgical Packs
  • Manufacturer
    Customed

Manufacturer

Customed