Events

Field Safety Notices about High Pressure Stopcock

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

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
    2015-07-16
  • Event Date Posted
    2015-08-11
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2015/08/11/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-high-pressure-stopcock-slavina-za-infuzionu-liniju/
  • 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
    This letter informs you that arcroyal is launching a voluntary withdrawal from the market all lots of high pressure faucets that are in stock and are in the box shelf life. this corrective action for the purpose of safety in the field is being implemented for the sake of the risk that the blister pack of these taps may contain a hole that can damage the sterile barrier. if the user is not aware of the existence of a hole in the package, transfer the microorganisms with faucets on the patient are possible when the clinician touches the faucet and then the sterile field, which he can result in the patient getting an infection.

Device

High Pressure Stopcock

Manufacturer

ArcRoyal Ltd.