Events

Alerte De Sécurité sur ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile

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.

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
    2012-07-10
  • Date de publication de l'événement
    2012-07-10
  • 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_20120710a.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 ultra fabric reinforced surgical gown x-large, sterile medical device manufacturer, kimberly-clark issued a medical device safety alert concerning ultra fabric reinforced surgical gown x-large, sterile. kimberly-clark has determined that the package seam of the above mentioned products may not remain properly sealed to ensure that the contents of the package are sterile. therefore, the affected products might not be sterile as labeled. kimberly-clark further explained that the package includes a caution statement indicating ‘contents sterile. unless this package is opened or damaged.’ the direct risk associated with this potential failure mode is that use of an affected non-sterile gown in surgery could lead to contamination of the surgical field. however, as the user inspects each package prior to use, the likelihood for use of a non-sterile gown in surgery is considered to be remote. according to kimberly-clark, the affected lots have been distributed in hong kong. kimberly-clark advised the affected users to stop using the impacted product lots. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 july 2012.

Device

ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile
  • Manufacturer
    Kimberly-Clark

Manufacturer

Kimberly-Clark