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U.S. Department of Health and Human Services

Class 2 Device Recall AquaBplus Water Purification System

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 Class 2 Device Recall AquaBplus Water Purification Systemsee related information
Date Initiated by FirmAugust 03, 2021
Create DateJuly 11, 2022
Recall Status1 Terminated 3 on April 10, 2024
Recall NumberZ-1364-2022
Recall Event ID 90411
510(K)NumberK133829 
Product Classification Subsystem, water purification - Product Code FIP
ProductAquaBplus 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)
Code Information UDI-DI: (01)04251285200227, (01)04251285200289, (01)0425128520; Serial Numbers: 7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502
Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
For Additional Information ContactFresenius Medical Care Technical Service
800-553-1109
Manufacturer 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
FDA Determined
Cause 2
Labeling Change Control
ActionCustomers 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.
Quantity in Commerce2 units
DistributionUS Nationwide distribution in the states of NC and WV.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FIP
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