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U.S. Department of Health and Human Services

Class 2 Device Recall Conductivity Standard Solution

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 Class 2 Device Recall Conductivity Standard Solutionsee related information
Date Initiated by FirmDecember 12, 2025
Date PostedJanuary 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1185-2026
Recall Event ID 98030
510(K)NumberK041636 
Product Classification Solution-test standard-conductivity, dialysis - Product Code FKH
ProductConductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters
Code Information Catalog/Model Numbers/ Lot Numbers / UDI codes: 10001 14250616-1019106 (01) 0 0850016 97600 0 (17) 251030 (10) SHOWCASE 10011 14250616-1019107 (01) 0 0850016 97609 3 (17) 251030 (10) SHOWCASE 10040c 50250624-1019120 (01) 0 0850016 97636 9 (17) 251030 (10) SHOWCASE 10040 50250624-1019119 (01) 0 0850016 97635 2 (17) 251030 (10) SHOWCASE 10032 14250616-1019108 (01) 0 0850016 97631 1 (17) 251030 (10) SHOWCASE 10041 50250522-1018643 (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10041 50250624-1019121 (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10021 15F250603-1018834 (01) 0 0850016 97619 2 (17) 251030 (10) SHOWCASE
FEI Number 3003145976
Recalling Firm/
Manufacturer		 NIPRO Technical Services, Inc.
3110 N Oakland Ste 101
Mesa AZ 85215-1168
For Additional Information ContactJaclyn Maiorana
480-517-4918
Manufacturer Reason
for Recall		due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 12/12/2025, the firm mailed/emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that specific lots of Conductivity Standard Solutions have been identified as not meeting specification requirements which potentially could result with inaccurate calibration leading to electrolyte imbalances consistent with hypo- or hypernatremia. Customer are instructed to" 1. Immediately stop using the affected products 2.Segregate and quarantine all affected units 3. Return the affected product for replacement or dispose of the product For questions associated with this recall or if further assistance is needed, contact Customer Service at 800-923-2486 or email sales@niprotechnical.com.
Quantity in Commerce499 units
DistributionU.S. Nationwide distribution in the states of AL, AR, AZ, CA, DE, FL, GA. IL, IN, KS, MI, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN TX, UT, VA, and WA.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FKH
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