Recall of Fresenius 132 Gallon GranuFlo Dissolution Unit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fresenius Medical Care Renal Therapies Group, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
  • Reason
    Dissolution units and replacement motors units do not provide full thermal protection for both the main and starter coils resulting in the generation of smoke and/or potentially lead to fire.
  • Action
    Fresenius issued an Urgent - Medical Device Correction notification, dated October 21, 2015, on 10/27/15. The letter identified the affected device and the reason for the recall. It also contained instructions (on how to perform the required wiring modification) along with a Reply Form. Customers are to return the form after completing the modification. Inquiries regarding the correction should be directed to Fresenius Technical Services at 800-227-2572, referencing the Field Action number FA-2015-01-W.


  • Model / Serial
    All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution.
  • Product Description
    Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. || For Use in the Preparation of acid concentrate for hemodialysis.
  • Manufacturer


  • Manufacturer Address
    Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
  • Manufacturer Parent Company (2017)
  • Source