Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-2159-2017

May 12, 2017

Class II

Product summary

Firm
Mesa Laboratories, Inc.
Event
Event 77290
Status
Terminated
Classification
Class II
Quantity
9900
Official record key
device-enforcement:Z-2159-2017

Official wording

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

Code information: Lot number: ML-C14-1352

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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