Mesa Laboratories, Inc. recalls MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02…

Recall date

May 12, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2159-2017

FDA classification

Class II

Brand / firm

Mesa Laboratories, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.