Events

Field Safety Notices about ArcRoyal High Pressure Stopcocks

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 ArcRoyal.

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
    2015-07-15
  • 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 field safety corrective action is being conducted due to the risk that the stopoocks blister packaging may contain a hole thus compromising the sterile barrier. should the user be unaware of a hole in the packaging, a transfer of microorganisms from the stopcock to the patient is possible when the clinician touches the stopcock and then onto the sterile field which may result in the patient contracting an infection.

Device

ArcRoyal High Pressure Stopcocks
  • Model / Serial
    12001914 High Pressure Stopcocks All Lots within expiry date 12-002022 High Pressure Stopoocks All Lots within expiry date 12-002023 High Pressure Stopoocks All Lots within expiry date 12-002024 High Pressure Stopcocks All Lots within expiry date
  • Manufacturer
    ArcRoyal

Manufacturer

ArcRoyal