Recall Z-1185-2026 ยท FKH Solution-Test Standard-Conductivity, Dialysis
NIPRO Technical Services, Inc.
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
| Date | Jan 27, 2026 (initiated Dec 12, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by 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 |
| Quantity | 499 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041636 | H&S-CONDUCTIVITY STANDARD SOLUTION H & S Technical Services, Jul 2, 2004 |