BEUDAMED
    FDA Recall Open, Classified

    Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;

    Recall: Z-2321-2026 · Initiated May 12, 2026

    Recall

    Recall Number
    Z-2321-2026
    Event Number
    98877
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KPO
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    May 12, 2026
    Posted
    June 5, 2026
    Address
    920 Winter St, Bld 920, Waltham, MA, 02451-1521

    Description

    Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;

    Reason

    Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.

    Action

    On 5/12/2026 an IMPORTANT MEDICAL DEVICE INFORMATION letters were sent to customers to inform them that manipulation of the luer-lock location during treatment preparation may result in fluid spillage onto the user and floor. This occurs prior to treatment and renders the product unusable. Direct contact with the fluid does not present any risk to the user as frangible manipulation only occurs after the peal seam has been broken and the two fluid compartments have been mixed. The potential risk associated with the affected Bicarby Dialysate product is a slip and fall hazard due to the presence of fluid on the floor.

    Distribution

    US Nationwide distribution in the states of NY, TN and TX.

    Quantity

    1,756,108 units