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U.S. Department of Health and Human Services

Class 2 Device Recall Conductivity/TDS Calibrator Solution

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  Class 2 Device Recall Conductivity/TDS Calibrator Solution see related information
Date Initiated by Firm May 12, 2017
Date Posted May 16, 2017
Recall Status1 Terminated 3 on December 19, 2017
Recall Number Z-2159-2017
Recall Event ID 77290
510(K)Number K033330  
Product Classification Solution-test standard-conductivity, dialysis - Product Code FKH
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.
Code Information Lot number: ML-C14-1352
Recalling Firm/
Manufacturer		 Mesa Laboratories, Inc.
12100 W 6th Ave
Lakewood CO 80228-1252
For Additional Information Contact
303-987-8000 Ext. 120
Manufacturer Reason
for Recall		 Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FKH and Original Applicant = MESA LABORATORIES, INC.
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