Fresenius Medical Care Holdings, Inc. Recall 90411
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)
Fresenius Medical Care Holdings, Inc. Recall 90411 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1364-2022 |
| Event ID | 90411 |
| Event 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) |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of NC and WV. |
| Quantity | 2 units |
| Recall Reason | 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 Classification | 20220720 |
| Device Code Info | UDI-DI: (01)04251285200227, (01)04251285200289, (01)0425128520; Serial Numbers: 7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502 |
| Center Classification Date | 20220711 |
| Recall Initiation Date | 20210803 |
| Recalling Firm | Fresenius Medical Care Holdings, Inc. |
| Initial Notification | Telephone |
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