FDA Device recall Z-0098-2021
AquaBplus and AquaBplus B2 Water Purification System
- FDA Device
- Class II
- terminated
- Published 2020-10-21
On 2020-10-21 the FDA classified a Class II recall of AquaBplus and AquaBplus B2 Water Purification System by Fresenius Medical Care Holdings, citing 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 connection….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0098-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-01 |
| Published | 2020-10-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | DE, NC, OK, PA, TX |
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
Reason
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.
Identifiers
| code_info | 9BDS1515 08D51544 OBDS1596 OBPS2864 9BDS1529 OBDS1545 OBPS2799 OBPS2884 9BPS2735 O…9BDS1515 08D51544 OBDS1596 OBPS2864 9BDS1529 OBDS1545 OBPS2799 OBPS2884 9BPS2735 OBDS1551 OBPS2800 OBPS2903 9BPS2767 08D51590 OBPS2810 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0098-2021%22
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