US AquaA 900H Water Purifier (Fresenius) – Concentrate Flow Error (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.

Recommended Action

Per FDA guidance

Fresenius Medical issued Urgent Medical Device Correction letter on 5-16-2024. Letter states reason for recall, health risk and action to take: A Fresenius Medical Care Water Systems Service Specialist will be contacting you to schedule an evaluation of your Water Treatment system and provide feedback on your system. For questions or concerns, please contact Fresenius Medical Care Technical Services at 800-227-2572, OPTION 4. " Please provide this letter to your Biomedical Technician " Report any complaints or adverse events to product.complaints@fmc-na.com or FDA MedWatchathttps://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting. " Provide this Customer Notice to all those who need to be aware within your organization. " Complete and return the attached reply form.