BEUDAMED
    FDA Recall 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 · Initiated March 18, 2021

    Recall

    Recall Number
    Z-1536-2021
    Event Number
    87659
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    FIP
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    March 18, 2021
    Terminated
    April 10, 2024
    Address
    920 Winter St, Bld 950, Waltham, MA, 02451-1521

    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

    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.

    Distribution

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

    Quantity

    27 units