medical Class II Updated 2022-07-20

Fresenius Medical Care Holdings, Inc. recalls AquaBplus Water Purification System, Part Number 24-2000-0,

Recalled Product

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)


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: (01)04251285200227, (01)04251285200289, (01)0425128520; Serial Numbers: 7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502
View official government recall

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