Events

Alerte De Sécurité sur Continuum Pump and Tubing Set

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

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
    2012-04-25
  • 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_20120425.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
    Field safety notice: medrad® continuum pump and tubing set medical device manufacturer, medrad, inc. has initiated a field safety corrective actions concerning medrad® continuum pump and tubing set [catalogue numbers: mik 200a, mil 200b, 3009135, 3015550, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159 and 3015161]. the recall is initiated because the tubing exhibits a variation that, when used in conjunction with any continuum pump, may result in flow rate accuracy performance issues. in addition, the manufacturer is also recalling the continuum pumps, calibrated using the tubing associated with this recall. for those serial numbers not affected by this recall, users are advised to follow the instructions enclosed to reset the maximum flow rate of their continuum pump(s) for future operation with the new tubing. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Continuum Pump and Tubing Set
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: MEDRAD® Continuum Pump and Tubing Set
  • Manufacturer
    MEDRAD

Manufacturer

MEDRAD
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    DH