Z-2159-2017Class II

MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton...

Name: Z-2159-2017 MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton...
Creator: Mesa Laboratories, Inc.
Published: 2017-05-12
License: https://open.fda.gov/license/

Mesa Laboratories Inc / initiated 2017-05-12 / Terminated / root cause: manufacturing process

FDA source

Mesa Laboratories, Inc. began a recall of MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle... on 2017-05-12. FDA classified it as Class II and gives the reason as "Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2159-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-12
Posted: 2017-05-16
Terminated: 2017-12-19
Recalling firm: Mesa Laboratories Inc
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.
Product code: FKH Solution-Test Standard-Conductivity, Dialysis
Reason for recall: Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 9900
Distribution: USA (nationwide) Distribution and Internationally to one customer in Canada, and govt/VA/military
Product codes and lots: Lot number: ML-C14-1352

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2159-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2159-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-24

Product code FKH

K033330Class IIConductivity/tds Calibrator SolutionMesa Laboratories, Inc. / cleared 2004-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)