Events

Avis De Sécurité sur Beacon® Tip Royal Flush and others

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Cook Medical Europe.

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
    2016-04-21
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Cook medical is initiating a voluntary recall of the products listed above. we have identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. our preliminary investigation into this matter has identified that environmental conditions, such as storage temperature, humidity, and the use of vaporized hydrogen peroxide (vhp) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence. we also recognize that there may be other undetermined contributors to this issue and continue to investigate. .

Device

Beacon® Tip Royal Flush and others

Manufacturer

Cook Medical Europe