AquaBplus Water Purification System, Part Number 24-2000-0… recallZ-1364-2022 · Fresenius Medical Care Holdings, Inc. · initiated Aug 3, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-1364-2022
- Status
- Terminated
- Initiated by the company
- Aug 3, 2021
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 2 units
- Product code
- FIP
- FDA submissions
- K133829
- Distribution
- US Nationwide distribution in the states of NC and WV.
Product description
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)
Code information (models, lots, serial numbers)
UDI-DI: (01)04251285200227, (01)04251285200289, (01)0425128520; Serial Numbers: 7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- AquaBplus & AquaBplus B2 & AquaBplus HF 2500VIVONIC GmbH · Subsystem, Water Purification1 recall0 reports
- AquaBplus AquaBplus B2 2500VIVONIC GmbH · Subsystem, Water Purification1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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