Events

Field Safety Notices about AMICUS CELL SEPARATOR 4R4580, AMICUS SEPARATOR REFURBISHED 4R4580R, AMICUS SEPARATOR THERAPEUTICS 4R4580TH

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 Fresenius Kabi.

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
  • 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
    The letter includes important product information regarding a software anomaly that may occur when performing procedures using platelet additive solution (pas) on the amicus device (4r4580, 4r4580r, and 4r4580th). this applies only to amicus procedures using pas. .

Device

AMICUS CELL SEPARATOR 4R4580, AMICUS SEPARATOR REFURBISHED 4R4580R, AMICUS SEPARATOR THERAPEUTIC...

Manufacturer

Fresenius Kabi