Class II

Medical Device Recall: 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 calibrat

NIPRO Technical Services, Inc. · December 12, 2025

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.

Product Description

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

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.

States Affected

NATIONWIDE

Quantity Affected

499 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1185-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.