Device Recall Conductivity/TDS Calibrator Solution

  • Model / Serial
    Lot number: ML-C14-1352
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution and Internationally to one customer in Canada, and govt/VA/military
  • Product 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Mesa Laboratories, Inc., 12100 W 6th Ave, Lakewood CO 80228-1252
  • Manufacturer Parent Company (2017)
  • Source
    USFDA