Recall Z-2159-2017
Mesa Laboratories, Inc. · initiated May 12, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot number: ML-C14-1352
Reason for recall
Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2159-2017
- Initiated
- May 12, 2017
- Posted by FDA
- May 16, 2017
- Terminated
- December 19, 2017
- Product code
- FKH – Solution-Test Standard-Conductivity, Dialysis
- Quantity
- 9900
- Distribution
- USA (nationwide) Distribution and Internationally to one customer in Canada, and govt/VA/military
- Recalling firm
- Mesa Laboratories, Inc., Lakewood, CO