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.
FDA Recall Z-2159-2017 · Posted 2017-05-16
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Recalling FirmMesa Laboratories, Inc.
Recall StatusTerminated
Product CodeFKH
Date Initiated2017-05-12
Date Terminated2017-12-19
Product Quantity9900
Reason for Recall
Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications.
Firm 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.
Root Cause
Process control
Distribution Pattern
USA (nationwide) Distribution and Internationally to one customer in Canada, and govt/VA/military
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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