BEUDAMED
    FDA Enforcement Class II Ongoing

    Bicarby Dialysate; Model number: RFP-400-G;

    Recall: Z-2401-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2401-2026
    Event ID
    98892
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2026
    Initiation Date
    May 7, 2026
    Classification Date
    June 11, 2026
    Address
    920 Winter St Bld 920, N/A, Waltham, MA, 02451-1521, United States

    Description

    Bicarby Dialysate; Model number: RFP-400-G;

    Reason

    There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.

    Code Info

    Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;

    Distribution

    Domestic: TX.

    Quantity

    4752