BEUDAMED
    FDA Recall Terminated

    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)

    Recall: Z-1364-2022 · Initiated August 3, 2021

    Recall

    Recall Number
    Z-1364-2022
    Event Number
    90411
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    FIP
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    August 3, 2021
    Terminated
    April 10, 2024
    Address
    920 Winter St, Bld 950, Waltham, MA, 02451-1521

    Description

    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)

    Reason

    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

    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.

    Distribution

    US Nationwide distribution in the states of NC and WV.

    Quantity

    2 units