Events

Avis De Sécurité sur Hudson RCI® Sheridan/CF® Cuffed Tracheal Tube

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Teleflex Medical.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2014-11-14
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Teleflex medical is recalling the product referenced above due to a labelling inconsistency. teleflex medical has received complaints that the labelling of units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube. it is unlikely that the mislabelling will result in any serious adverse health consequences; however, it may cause difficulty in obtaining a proper seal between the device and the patient, possibly necessitating reintubation of the patient and resulting in a delay in treatment. teleflex medical is recalling the affected lot in an effort to provide our customers and their patients with the highest quality product possible.

Device

Hudson RCI® Sheridan/CF® Cuffed Tracheal Tube

Manufacturer

Teleflex Medical