BEUDAMED
    FDA Recall Open, Classified

    Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters

    Recall: Z-1185-2026 · Initiated December 12, 2025

    Recall

    Recall Number
    Z-1185-2026
    Event Number
    98030
    Firm
    NIPRO Technical Services, Inc.
    FEI Number
    3003145976
    Product Code
    FKH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 12, 2025
    Posted
    January 27, 2026
    Address
    3110 N Oakland, Ste 101, Mesa, AZ, 85215-1168

    Description

    Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters

    Reason

    due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.

    Action

    On 12/12/2025, the firm mailed/emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that specific lots of Conductivity Standard Solutions have been identified as not meeting specification requirements which potentially could result with inaccurate calibration leading to electrolyte imbalances consistent with hypo- or hypernatremia. Customer are instructed to" 1. Immediately stop using the affected products 2.Segregate and quarantine all affected units 3. Return the affected product for replacement or dispose of the product For questions associated with this recall or if further assistance is needed, contact Customer Service at 800-923-2486 or email [email protected].

    Distribution

    U.S. Nationwide distribution in the states of AL, AR, AZ, CA, DE, FL, GA. IL, IN, KS, MI, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN TX, UT, VA, and WA.

    Quantity

    499 units