CLASS II Device recall · Reported 21 Oct 2020 · FDA Enforcement Report
AquaBplus and AquaBplus B2 Water Purification System recalled
Fresenius Medical Care Holdings is recalling AquaBplus and AquaBplus B2 Water Purification System, distributed in Delaware, North Carolina, Oklahoma, Pennsylvania, Texas. The recall was initiated on 1 Sep 2020 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-0098-2021
- FDA event ID
- 86410
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Sep 2020
- FDA classified
- 13 Oct 2020
- Reported
- 21 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Sep 2020 | Recall initiated by company | |
| 13 Oct 2020 | Classified by FDA | +42 days |
| 21 Oct 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
US distribution to DE, NC, OK, PA, and TX.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
9BDS1515 08D51544 OBDS1596 OBPS2864 9BDS1529 OBDS1545 OBPS2799 OBPS2884 9BPS2735 OBDS1551 OBPS2800 OBPS2903 9BPS2767 08D51590 OBPS2810
Where was it sold?
US distribution to DE, NC, OK, PA, and TX.
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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