Z-2159-2017 Class II Terminated
FDA device recall Z-2159-2017 was initiated by Mesa Laboratories, Inc. on May 12, 2017 and is designated Class II. Reason for recall: Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications. The recall status is terminated (terminated December 19, 2017). Affected quantity: 9900.
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2017
- Initiation Date
- May 12, 2017
- Termination Date
- December 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9900
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.
Distribution Pattern
USA (nationwide) Distribution and Internationally to one customer in Canada, and govt/VA/military
Code Information
Lot number: ML-C14-1352