Events

Field Safety Notices about Various devices

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by VASCUTEK 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
    2017-11-30
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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