Events

Alerte De Sécurité sur Heater-Cooler Devices

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Terumo Cardiovascular Systems 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
    2016-06-14
  • Date de publication de l'événement
    2016-06-14
  • 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_20160614.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: terumo heater-cooler devices medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs), has issued a medical device safety alert concerning its heater-cooler devices. the affected devices are identified as follows:- a) sams tcm ii cooling and heating systems [catalog number: 4416, 164935, 164940] b) sams dual cooler-heaters [catalog number: 4332, 14114, 13460] the manufacturer is notifying all users of its heater-cooler devices that the distributor, intercon chemical company, no longer sells the intechlor sanitizer (product code 205) referenced in its heater-cooler cleaning instructions. however, the identical sanitizer is available from other sources. updated instructions on how to source a sanitizer are provided by the manufacturer. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 june 2016.

Device

Heater-Cooler Devices

Manufacturer

Terumo Cardiovascular Systems Corporation