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)
Check against the official notice below — it lists the full affected range.
Fresenius Medical Care is recalling AquaBplus water purification systems due to an error in the US Installation Guideline. The guideline incorrectly instructed that 3-ring mains could be installed instead of 2-ring mains with the AquaBplus 2000 device; however, when 3-ring mains are used, the heat disinfection process may not be as effective as with the correct 2-ring main installation. The affected products were distributed nationwide in North Carolina and West Virginia, with 2 units involved.
The recall affects systems with specific UDI-DI codes and serial numbers including 7BPS1621, 7BDS0783, 7BFS0517, 7BPS1611, 7BDS0776, and 7BFS0502. The source record does not specify a remedy or what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: US Nationwide distribution in the states of NC and WV. Quantity: 2 units Lot/code info: UDI-DI: (01)04251285200227, (01)04251285200289, (01)0425128520; Serial Numbers: 7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.