BEUDAMED
    FDA Recall 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 · Initiated May 12, 2017

    Recall

    Recall Number
    Z-2159-2017
    Event Number
    77290
    Firm
    Mesa Laboratories, Inc.
    FEI Number
    1720309
    Product Code
    FKH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 12, 2017
    Posted
    May 16, 2017
    Terminated
    December 19, 2017
    Address
    12100 W 6th Ave, Lakewood, CO, 80228-1252

    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.

    Action

    MesaLabs sent an Device Correction Notice dated May 12, 2017, via certified letter to destroy product by pouring it down the drain and free replacements will be shipped. For further questions, please call (303) 987-8000 ext. 120.

    Distribution

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

    Quantity

    9900