Events

Recall Or Safety Alert for Apparatus of Normo-Hypothermia of 220V, code 16-02-50 and of 320V, code 16-02-80

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Sorin Group Deustchland GmbH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety Alert
  • Date
    2014-08-05
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Importance of the correct disinfection and cleaning of the Normo-Hypothermia Apparatus, manufactured by Sorin Group Deustchland GmbH, Germany, due to the possible risk of infection of the patient by mycobacteria during cardiac surgery.

Device

Apparatus of Normo-Hypothermia of 220V, code 16-02-50 and of 320V, code 16-02-80

Manufacturer

Sorin Group Deustchland GmbH