Z-0098-2021Class II

AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic...

Name: Z-0098-2021 AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2020-09-01
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2020-09-01 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants... on 2020-09-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0098-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-01
Posted: 2020-10-13
Terminated: 2021-01-20
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
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
Product code: FIP Subsystem, Water Purification
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 15 units
Distribution: US distribution to DE, NC, OK, PA, and TX.
Product codes and lots: 9BDS1515 08D51544 OBDS1596 OBPS2864 9BDS1529 OBDS1545 OBPS2799 OBPS2884 9BPS2735 OBDS1551 OBPS2800 OBPS2903 9BPS2767 08D51590 OBPS2810

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0098-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0098-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-21	2020-10-13

Product code FIP

K133829Class IIAquabplus,aquabplus & Aquabplus B2,aquabplus&aquabplus Hf,aquabplus& Aquabplus B2& Aquablus HFVivonic GmbH / cleared 2014-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)