Recall Z-2159-2017— Mesa Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Mesa Laboratories, Inc., initiated 2017-05-12, terminated 2017-12-19. It names one FDA 510(k) clearance: K033330. 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.. Reason: Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications..
- Recalling firm
- Mesa Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-12
- Terminated
- 2017-12-19
- Firm location
- Lakewood, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.