Events

Alerte De Sécurité sur CIDEX Activated Glutaraldehyde Solution

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
    2015-08-04
  • Date de publication de l'événement
    2015-08-04
  • 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_20150804_a.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 cidex activated glutaraldehyde solution medical device manufacturer, advanced sterilization products, has issued a medical device safety alert concerning its cidex activated glutaraldehyde solution. the manufacturer recently determined, as part of its routine quality program, that it may lack the adequate data to support the entire 24-month shelf life of cidex activated glutaraldehyde solution. the manufacturer determined that data for cidex activated glutaraldehyde solution supports a 12-month shelf life. the cidex activated glutaraldehyde solution is currently labeled for a 24-month shelf life. while the product has a maximum 14-day reuse life, data shows that the ph level of the cidex activated glutaraldehyde solution may be below specification for up to 2 hours after activation. use of cidex activated glutaraldehyde solution after 12 months may result in inadequate medical device reprocessing (disinfection/sterilization) or re-contamination if it is used for reprocessing within the first 2 hours of activation. the manufacturer advises users to check the expiration date on all bottles of cidex activated glutaraldehyde solution currently in inventory. 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 04 august 2015.

Device

CIDEX Activated Glutaraldehyde Solution
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Advanced Sterilization Products CIDEX Activated Glutaraldehyde Solution
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products