FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
- Recall number
- Z-2141-2024
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
- Status
- Open, Classified
- Initiated
- 2024-05-16
- Posted
- 2024-06-13
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of AL, IN, AK, WI.
- Lot, serial or model codes
- UDI-DI: 04251285200357 Serial Numbers: 2AAV0003 2AAV0029 2AAV0037 3AAV0087
- 510(k) numbers
- ["K143617"]
- PMA numbers
- not on file
- Product code
- FIP
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28