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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius

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  Class 2 Device Recall Fresenius see related information
Date Initiated by Firm March 18, 2021
Create Date May 07, 2021
Recall Status1 Terminated 3 on April 10, 2024
Recall Number Z-1536-2021
Recall Event ID 87659
510(K)Number K133829  
Product Classification Subsystem, water purification - Product Code FIP
Product AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies.
Fresenius P/N 24-2500-0

All 3 units make up the AquaBplus 2500Fresenius Part Number:
G02040109-US AquaBplus 3000 - Typ USA
G02040115-US AquaBplus 2500 - Typ USA
G02040120FMC-US AquaBplus HF- Typ USA
Code Information Serial number first stage (AquaBplus): 5BPS0601 6BPS0933 7BPS1457 7BPS1526 7BPS1458 7BPS1527 8BPS1801 8BPS1800 8BPS1870 8BPS1883 8BPS1898 8BPS1885 8BPS1884 8BPS1918 7BPS14443 8BPS1930 8BPS1928 8BPS1929 8BPS1937 8BPS1927 8BPS2052 8BPS2081 8BPS2108 8BPS2157 9BPS2234 7BPS1441 9BPS2512.  Serial number second ¿stage(B2): 5BDS0194 6BDS067 7BDS0692 7BDS0726 7BDS0643 7BDS0722 8BDS0907 8BDS0909 8BDS0958 8BDS0960 8BDS0964 8BDS0963 8BDS0965 8BDS0978 7BDS0684 8BDS0989 8BDS0997 8BDS0995 8BDS0998 8BDS0992 8BDS1075 8BDS1087 8BDS1102 8BDS1139 9BDS1181 7BDS0683 9BDS1373.  Serial number HF option: 5BFS0125 6BFS0241 7BFS0413 7BFS0456 7BFS0446 7BFS0486 8BFS0541 8BFS0609 8BFS0644 8BFS0665 8BFS0663 8BFS0577 8BFS0621 8BFS0616 7BFS0439 8BFS0686 8BFS0702 8BFS0703 8BFS0695 8BFS0676 8BFS0727 8BFS0757 8BFS0776 8BFS0805 9BFS0845 7BFS0477 9BFS0997 
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
781-6999580
Manufacturer Reason
for Recall		 AquaBplus HF module on the AquaBplus 2500 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 2500 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 Fresenius issued Urgent Medical Device Alert (FA-2021-07-C) to customers on 03/18/2021 via First Class Mail. Letter states reason for recall, health risk and action to take: Please note that all installed AquaBplus 2500 osmosis systems are validated for chemical disinfection upon installation. You may continue to use your HF module, since the chemical disinfection remains the primary disinfection method. The system will continue to provide dialysis water that meets Association for the Advancement of Medical Instrumentation (AAMI) standards; thus, there is no risk introduced. You should continue to perform all microbiological testing per clinical policies and procedures. In the event your ring mains endotoxin or microbiological results are above action limits, please inform your Fresenius Medical Care Renal Therapies Group (FMCRTG) Water Systems Service Specialist. An FMCRTG Water Systems Service Specialist will be contacting you to schedule an evaluation of your Water Treatment system and provide feedback on your system. For questions or concerns, please contact FMCRTG Technical Support Services at 888-553-1109.
Quantity in Commerce 27 units
Distribution US Nationwide distribution in the states of FL, MA, MD, MI, MO, NC, NJ, NY, PA, PR, SC, TN, TX.
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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