FDA-Device2017-05-31Class II
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 equipme
Mesa Laboratories, Inc.
Hazard
Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications.
Sold states
USA (nationwide) Distribution and Internationally to one customer in Canada, and govt/VA/military
Affected count
9900
Manufactured in
12100 W 6th Ave, Lakewood, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2017Don't want to check this manually?
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