Events

Field Safety Notices about AV system F 204 B AV/ Hemodialysis bloodlines

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Fresenius Medical Care.

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
    2015-12-30
  • Event Date Posted
    2016-01-28
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2016/01/28/obavestenje-o-povlacenju-medicinskog-sredstva-sa-trzista-2/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    No adverse reaction to the medical devices occured. internal product quality control as well as by reporting the complaint on the inadequate quality of the medical device, we found that some specimens from the above batch (not all!) have a pumped segment of the arterial portion of the av system shorter by 9% in relation to the prescribed specification. this leads to difficult but not impossible installation of av system.

Device

AV system F 204 B AV/ Hemodialysis bloodlines

Manufacturer

Fresenius Medical Care