Events

Avis De Sécurité sur Various devices

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 VASCUTEK 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
    2017-11-30
  • 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
    This notice is to inform you about important information concerning updates to the instructions for use (ifu) for the above products. vascutek ltd has taken the opportunity to conduct a full review of the ifu contents to ensure consistency across all product families and to ensure that the instructions for use provide state of the art instruction and content to users. as a result of these updates, further clarity will be provided to clinicians regarding immersion of grafts in saline solution, and to enhance knowledge on the use of formaldehyde in the manufacturing process. further details are provided overleaf,.

Device

Various devices
  • Modèle / numéro de série
    Lot/Serial Number All Gelsoft^", Gelsoft™ ERS, Gelsoft™ Plus, Gelsoft™ Plus ERS, Gelseal™, Gelseal™ ERT, Gelweave™, K-Thin, K-Thin ERS, and Gelseal™ Plus Vascular Prostheses All Fluoropassiv™, Fluoropassiv™ ER, Thin Wall Fluoropassiv and Thin Wall Fluoropassiv ER Vascular Prostheses All Cardiovascular Fabric Patches All SealPTFE™ and Taperflo™ Vascular Prostheses All Lots
  • Manufacturer
    VASCUTEK Ltd

Manufacturer

VASCUTEK Ltd