Events

Alerte De Sécurité sur STERRAD Systems

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

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
    2014-11-27
  • Date de publication de l'événement
    2014-11-27
  • 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_20141127a.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: advanced sterilization products sterrad systems medical device manufacturer, advanced sterilization products, has issued a medical device safety alert concerning its sterrad systems [models: 50, 100s, 200, 100nx and nx]. the manufacturer recently determined, as part of its routine quality programme that the leak indicator on the sterrad system cassettes packaging assembly may not function properly after exposure to hydrogen peroxide. sterrad system cassette packaging assemblies are designed with a leak indicator on the inner package to provide a visual colour indication in the event hydrogen peroxide has leaked from the cassettes. the manufacturer’s recommendations on exercising extra precaution when handling new sterrad system cassettes are as follows: the customer should wear personal protective equipment (e.G. gloves) when handling the cassette. this is a precautionary measure in the event that the customer comes in contact with hydrogen peroxide. in addition to wearing personal protective equipment, the customer should perform a visual inspection of the cassette package to look for signs of liquid leakage prior to opening the package. if a liquid leak is observed, the customer should dispose of the cassette package immediately and contact the local supplier. if customers come into contact with hydrogen peroxide, they should immediately flush the affected area with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. medical attention should be sought promptly if symptoms occur after washing. contaminated clothing should be washed before reuse. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 november 2014.

Device

STERRAD Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Advanced Sterilization Products STERRAD Systems
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products