Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1364-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: August 3, 2021

Date Posted: July 20, 2022

Recall Number: Z-1364-2022

Event ID: 90411

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

Status: Terminated

Product Quantity: 2 units

Code Information:

UDI-DI: (01)04251285200227, (01)04251285200289, (01)0425128520; Serial Numbers: 7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502

Distribution Pattern:

US Nationwide distribution in the states of NC and WV.

Voluntary or Mandated:

Voluntary: Firm initiated