NIPRO Technical Services recalled 499 units of Conductivity Standard Solutions on December 12, 2025. A defect affects the conductivity values, leading to incorrect readings for dialysate. Patients and healthcare providers must stop using the product immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact NIPRO Technical Services, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled products include Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041. These solutions calibrated conductivity meters and were distributed nationwide across multiple states.
The defect in the conductivity values can lead to incorrect readings, which pose a significant risk for patients relying on accurate measurements for dialysate. This discrepancy can affect treatment decisions.
Stop using the Conductivity Standard Solutions immediately. Follow the manufacturer's recall instructions and contact NIPRO Technical Services or your healthcare provider for further guidance.
For more information, contact NIPRO Technical Services at their official website or through the link provided in the FDA notice.
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