Events

Alerte De Sécurité sur 15L Cycler Drainage Bag

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

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
    2013-11-06
  • Date de publication de l'événement
    2013-11-06
  • 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_20131106a.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: baxter 15l cycler drainage bag the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning 15l cycler drainage bag manufactured by baxter healthcare. the affected product code is r5c4145p. baxter has identified an issue with the roberts clamp (large clamp on the drainage bag) that is used to close the drain tube on the 15l cycler drainage bag. the large clamp may not fully close the 15l cycler drainage bag drain tube after filling and may result in leakage from the drain tube. the manufacturer is advising users of the potential issue with the clamps and to take extra care to ensure the clamp on the drain tube is closed. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01096-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 november 2013.

Device

15L Cycler Drainage Bag
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter 15L Cycler Drainage Bag
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare