FDA-Device2026-02-04Class II
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
NIPRO Technical Services, Inc.
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.
Sold states
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.
Affected count
499 units
Manufactured in
3110 N Oakland Ste 101, N/A, Mesa, AZ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1185-2026Don't want to check this manually?
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