Events

Recall of DESILET FEMORAL FOR HEMODIALYSIS

According to DPM Tunisie, this recall involved a device in Tunisia that was produced by ADHE-ELS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2018-12-07
  • Event Country
    Tunisia
  • Event Source
    DPMT
  • Event Source URL
    http://www.dpm.tn/
  • Notes / Alerts
    Tunisian data is current through December 2018. All of the data comes from DPM Tunisie, 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 Tunisia.
  • Extra notes in the data
    Country: Tunisia
  • Reason
    «scarpa hematoma with false aneurysm of the superficial femoral artery in hemodialysis patients».

Device

DESILET FEMORAL FOR HEMODIALYSIS
  • Model / Serial
    All lots // change decision for lot 801007 only
  • Manufacturer
    ADHE-ELS

Manufacturer

ADHE-ELS