Events

Alerte De Sécurité sur Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit

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

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
    2013-05-08
  • Date de publication de l'événement
    2013-05-08
  • 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_20130508a.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: cardinal health various presource kits containing a pre-assembled anesthesia circuit the united states food and drug administration (fda) has issued a medical device safety alert, concerning various presource kits containing a pre-assembled anesthesia circuit, manufactured by cardinal health. cardinal health discovered that various presource kits containing a pre-assembled anesthesia circuit and filter may contain outer plastic packaging on one or more components. if the packaging is removed without dissembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction in airflow. this may result in serious adverse health consequences including low blood oxygen (hypoxia), suffocation and death. according to the fda, cardinal health has notified customers of the problem and products affected on 26 march 2013 and advised customers to examine their inventories, identify and locate the products affected, notify clinicians, and affix a warning label on the front of each kit. the warning label instructs clinicians to remove and discard the anesthesia circuit and filter assembly. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safety alertsforhumanmedicalproducts/ucm351024.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ ucm350996.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 08 may 2013.

Device

Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cardinal Health Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health