Events

Alerte De Sécurité sur STERRAD 100NX System cassettes

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
    2013-08-01
  • Date de publication de l'événement
    2013-08-01
  • 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_20130801a.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 100nx system cassettes medical device manufacturer, advanced sterilization products (asp), has issued a field safety notice concerning sterrad 100nx system cassettes. asp recently determined, as part of its routine quality program, that it does not have adequate data to support the effectiveness of the packaging’s leak indicator for the entire duration of the sterrad 100nx system cassette’s 15-month shelf life. asp has determined that data for the leak indicator is effective for only 12 months of the cassette’s 15-month shelf life. the likelihood of a leak is extremely low, and there have been no reported cases of a leak where the indicator was not effective in identifying the leak. the cassette itself is fully functional and there is no compromise to the efficacy of the cassette or to sterilization process as there is data to support the cassette’s 15-month shelf life. asp plans to update the shelf life of affected products. in the meantime, until the above change takes effect, customers are advised to check the expiration date on all affected products and follow the advice related to exercising extra precaution on handling hazardous materials as mentioned in the field safety notice. alternatively, the concerned product can be returned to the manufacturer to have the shelf life of the affected products to be consistent with the leak indicator. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 1 august 2013.

Device

STERRAD 100NX System cassettes
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Advanced Sterilization Products STERRAD 100NX System cassettes
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products