RecallDepth

Conductivity 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

Company
Nipro Technical Services, Inc.
Recall Initiated
December 12, 2025
Posted
January 27, 2026
Recall Number
Z-1185-2026
Quantity
499 units
Firm Location
Mesa, AZ

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.

Distribution

U.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.

Lot / Code Info

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

Root Cause

Under Investigation by firm

Action Taken

On 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.