BEUDAMED
    FDA Enforcement Class II Terminated

    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

    Recall: Z-1536-2021 · Reported May 19, 2021

    Enforcement

    Recall Number
    Z-1536-2021
    Event ID
    87659
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 19, 2021
    Initiation Date
    March 18, 2021
    Classification Date
    May 7, 2021
    Termination Date
    April 10, 2024
    Address
    920 Winter St Bld 950, Waltham, MA, 02451-1521, United States

    Description

    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

    Reason

    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

    Code Info

    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

    Distribution

    US Nationwide distribution in the states of FL, MA, MD, MI, MO, NC, NJ, NY, PA, PR, SC, TN, TX.

    Quantity

    27 units