Events

Alerte De Sécurité sur Coiled Tube Infusors

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 Ltd.

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
    2013-06-05
  • Date de publication de l'événement
    2013-06-05
  • 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_20130605a.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 coiled tube infusors medical device manufacturer, baxter healthcare ltd, has issued a medical device safety alert concerning the coiled tube infusors [product codes: 2c1071kjp, 2c1075kjp, 2c1976kj]. the affected products were manufactured between november 2008 through september 2009. due to an increase in complaints for leaks at the distal male luer and luer cap, baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the luer. complaint rates for leaks have since decreased. baxter wants to ensure that no affected product remains in the field. leakage at the connection of the blue winged cap and the distal male luer presents the potential for delay/interruption of therapy and exposure to hazardous solutions. the manufacturer requests users to locate and return the affected products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 jun 2013.

Device

Coiled Tube Infusors
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Healthcare Coiled Tube Infusors
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd