Z-1364-2022Class II

AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US)...

Name: Z-1364-2022 AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US)...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2021-08-03
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2021-08-03 / Terminated / root cause: labeling and UDI

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ... on 2021-08-03. FDA classified it as Class II and gives the reason as "AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1364-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-03
Posted: 2022-07-11
Terminated: 2024-04-10
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)
Product code: FIP Subsystem, Water Purification
Reason for recall: AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Customers were notified via telephone beginning 8/3/21. An FMCRTG, LLC Water Systems Specialist contacted the two consignees via phone and scheduled a time to perform the inspection on the AquaBplus 2000 devices. No formal written communication will be sent since calls and inspections have already performed.
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the states of NC and WV.
Product codes and lots: UDI-DI: (01)04251285200227, (01)04251285200289, (01)0425128520; Serial Numbers: 7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1364-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1364-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-20	2022-07-11

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)