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NIPRO Technical Services, Inc.: Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Soluti

Medical DevicesSource: FDA (device) · Date: 2026-02-04

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
NIPRO Technical Services, Inc.
Product
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
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2025-12-12
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
Product quantity
499 units
Voluntary mandated
Voluntary: Firm initiated
City
Mesa
State
AZ
Country
United States
Event id
98030
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