CLASS II Device recall · Reported 20 Jul 2022 · FDA Enforcement Report
AquaBplus Water Purification System recalled by Fresenius Medical Care
Fresenius Medical Care Holdings is recalling AquaBplus Water Purification System, distributed nationwide in the US. The recall was initiated on 3 Aug 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1364-2022
- FDA event ID
- 90411
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Aug 2021
- FDA classified
- 11 Jul 2022
- Reported
- 20 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 3 Aug 2021 | Recall initiated by company | |
| 11 Jul 2022 | Classified by FDA | +342 days |
| 20 Jul 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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)
Where it was distributed
US Nationwide distribution in the states of NC and WV.
Questions about this recall
Why was it 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
Which lots are affected?
UDI-DI: (01)04251285200227, (01)04251285200289, (01)0425128520; Serial Numbers: 7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502
Where was it sold?
US Nationwide distribution in the states of NC and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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