Events

Alerte De Sécurité sur Uromatic Tur Administration 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 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
    2016-01-14
  • Date de publication de l'événement
    2016-01-14
  • 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_20160114.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 healthcare uromatic tur administration set medical device manufacturer, baxter healthcare has issued a medical device safety alert concerning uromatic tur administration set. [product code: emc4015n; lot numbers: 14i01v842m, 14j30v283 and 14k03v521] the manufacturer has issued a recall for the above referenced lots due to complaints received related to the disconnection of the spike from the tubing of the set. according to the manufacturer, the most likely hazard resulting from this issue is delay / interruption of therapy. however, disconnections also have the potential to lead to microbial contamination of the fluid path and hence contamination of the surgical field. the manufacturer has not received any reports of adverse event or patient injury related to this issue. according to the local supplier, the affected products are distributed in hong kong. product recall in ongoing. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 january 2016.

Device

Uromatic Tur Administration Set
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Healthcare Uromatic Tur Administration Set
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare