Events

Avis De Sécurité sur High Pressure Stopcock

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par ArcRoyal Ltd..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2015-07-16
  • Date de publication de l'événement
    2015-08-11
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    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 / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.