NIPRO Technical Services, Inc. recalls Conductivity Standard Solution Catalog/Model Numbers: 10001

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.

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 sales@niprotechnical.com.

• FDA enforcement recordOfficial FDA database entry for Z-1185-2026
• FDA 510(k) clearance · K041636The device's official FDA premarket clearance record
• FDA device classification · FKHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5820The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find NIPRO Technical Services, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.