FDA recall Z-1185-2026

NIPRO Technical Services, Inc. · Class II · device

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 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.

Key facts

Status
Ongoing
Initiation date
2025-12-12
Report date
2026-02-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mesa, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1185-2026