Events

Field Safety Notices about Hudson RCI® Sheridan/CF® Cuffed Tracheal Tube

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Teleflex Medical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2014-11-14
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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