Events

Alerte De Sécurité sur KIMGUARD Container Filters

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Kimberly-Clark 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
    2013-03-18
  • Date de publication de l'événement
    2013-03-18
  • 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_20130318.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: kimberly-clark kimguard container filters medical device manufacturer, kimberly-clark corporation issued a medical device safety alert concerning 9in. x 9in. (23cm x 23cm) square sized kimguard container filters. the affected product code is 68509 and the affected lot numbers are mf1279xxx, mf1287xxx, mf1288xxx. according to the manufacturer, some individual container filter units from the above product lots might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. complaints received so far involved defects that were identified prior to use of possibly affected instruments or supplies on patients. kimberly-clark stressed that standard practice involves inspecting the sterilization container and filter for sterility breaches prior to use. if the defect is not detected upon standard inspection, contamination of surgical instruments and supplies within the container could be resulted. kimberly-clark asia pacific health care confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 march 2013.

Device

KIMGUARD Container Filters
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Kimberly-Clark KIMGUARD Container Filters
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation