BEUDAMED
    FDA Enforcement Class II Terminated

    MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and do not come into contact with the patient.

    Recall: Z-2159-2017 · Reported May 31, 2017

    Enforcement

    Recall Number
    Z-2159-2017
    Event ID
    77290
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mesa Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2017
    Initiation Date
    May 12, 2017
    Classification Date
    May 24, 2017
    Termination Date
    December 19, 2017
    Address
    12100 W 6th Ave, Lakewood, CO, 80228-1252, United States

    Description

    MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and do not come into contact with the patient.

    Reason

    Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications.

    Code Info

    Lot number: ML-C14-1352

    Distribution

    USA (nationwide) Distribution and Internationally to one customer in Canada, and govt/VA/military

    Quantity

    9900