Events

Recall of FiberOptix Ultra 8 IAB: 8Fr 30cc Ultra 8 IAB: 8Fr 30cc FiberOptix Ultra 8 IAB: 8Fr 40cc Ultra 8 IAB: 8Fr 40cc UltraFlex IAB: 7.5Fr 30cc UltraFlex IAB: 7.5Fr 35cc UltraFlex IAB: 7.5Fr 40cc RediGuard IAB: 7Fr 30cc Percutaneous Insertion Tray

According to Valvira - National Supervisory Authority for Welfare and Health (via FOI), this recall involved a device in Finland that was produced by Arrow International INC.

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
  • Event ID
    2016-0357
  • Date
    2016-02-22
  • Event Country
    Finland
  • Event Source
    VNSAWH
  • Notes / Alerts
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Extra notes in the data
    Source: FSCA
  • Reason
    Device failure / feature before use - manufacturing.

Device

FiberOptix Ultra 8 IAB: 8Fr 30cc Ultra 8 IAB: 8Fr 30cc FiberOptix Ultra 8 IAB: 8Fr 40cc Ultra ...

Manufacturer

Arrow International INC