Recall Z-2159-2017 ยท FKH Solution-Test Standard-Conductivity, Dialysis
Mesa Laboratories, Inc.
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 calibra
| Date | May 16, 2017 (initiated May 12, 2017) |
| Status | Terminated |
| Reason | Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications. |
| 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 | 9900 |
| Distribution | USA (nationwide) Distribution and Internationally to one customer in Canada, and govt/VA/military |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033330 | CONDUCTIVITY/TDS CALIBRATOR SOLUTION Mesa Laboratories, Inc., Feb 27, 2004 |