Events

Field Safety Notices about Beacon® Tip Royal Flush and others

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 Cook Medical Europe.

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
    2016-04-21
  • 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
    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