Events

Field Safety Notices about Metalline Tracheo

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 Lohmann & Rauscher GmbH & Co.KG.

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
  • 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
    In the course of a control of the production process by our quality assurance de- partment (qa), in single cases leakages (cannulas) were discovered in the sealing of the sterile packaging of the final products (14 products with leakages (cannulas) in 82.200 products tested). the affected batch was partly delivered in the market (in the market: 36.950 pieces). .

Device

Metalline Tracheo

Manufacturer

Lohmann & Rauscher GmbH & Co.KG