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
FDA Recall Z-1185-2026 · Posted 2026-01-27
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Recalling FirmNIPRO Technical Services, Inc.
Recall StatusOpen, Classified
Product CodeFKH
Date Initiated2025-12-12
Product Quantity499 units
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.
Firm Action
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 [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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