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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 System see related information
Date Initiated by Firm August 03, 2021
Create Date July 11, 2022
Recall Status1 Terminated 3 on April 10, 2024
Recall Number Z-1364-2022
Recall Event ID 90411
510(K)Number K133829  
Product Classification Subsystem, water purification - Product Code FIP
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)
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 Contact Fresenius 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
Action 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.
Quantity in Commerce 2 units
Distribution US Nationwide distribution in the states of NC and WV.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FIP and Original Applicant = VIVONIC GMBH
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