—#194345

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)

FDA product code: FIP — Subsystem, Water Purification
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K133829
Affected lot / code info: UDI-DI: (01)04251285200227, (01)04251285200289, (01)0425128520; Serial Numbers: 7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Customers were notified via telephone beginning 8/3/21. An FMCRTG, LLC Water Systems Specialist contacted the two consignees via phone and scheduled a time to perform the inspection on the AquaBplus 2000 devices. No formal written communication will be sent since calls and inspections have already performed.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Bld 950, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: US Nationwide distribution in the states of NC and WV.

Timeline

Recall initiated: 2021-08-03
Terminated: 2024-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194345. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.