FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0
- Recall number
- Z-0098-2021
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0
- Status
- Terminated
- Initiated
- 2020-09-01
- Posted
- not on file
- Terminated
- 2021-01-20
- Reason
- Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff.
- Root cause
- Process control
- Action
- Fresenius Medical Care issued letter dated 9/1/20 stating reason for recall, health risk and action to take: A Fresenius Medical Care Renal Therapies Group Water Systems Service Specialist will be contacting you to schedule an appointment to check the connection and replace if necessary. In the meantime, we ask that you do not perform any repairs or maintenance on the machine and wait for your scheduled service date. For questions or concerns or if you need service prior to your scheduled service date, please contact Technical Support Services at 888-553-1109.
- Quantity
- 15 units
- Distribution
- US distribution to DE, NC, OK, PA, and TX.
- Lot, serial or model codes
- 9BDS1515 08D51544 OBDS1596 OBPS2864 9BDS1529 OBDS1545 OBPS2799 OBPS2884 9BPS2735 OBDS1551 OBPS2800 OBPS2903 9BPS2767 08D51590 OBPS2810
- 510(k) numbers
- ["K133829"]
- 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