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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

NIPRO Conductivity Standard Solution Recalled for Incorrect Calibration Values

Agency Publication Date: January 27, 2026
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Summary

NIPRO Technical Services, Inc. has recalled approximately 499 units of Conductivity Standard Solution due to a defect that reports incorrect conductivity values. These solutions are used to calibrate meters that measure dialysate used in medical procedures. This recall affects catalog numbers 10001, 10011, 10021, 10032, 10040, 10040c, and 10041. Using an incorrectly calibrated meter could result in reporting inaccurate dialysate conductivity, potentially affecting patient treatment.

Risk

If the solution provides incorrect conductivity values during calibration, the meters used to monitor dialysate will report inaccurate readings. This could lead to the preparation of improper dialysis fluid, which may result in serious health complications or injury for patients undergoing dialysis.

What You Should Do

  1. This recall involves NIPRO Technical Services Conductivity Standard Solutions with catalog numbers 10001, 10011, 10021, 10032, 10040, 10040c, and 10041.
  2. Check the bottle label or packaging for the catalog number, lot number, or Unique Device Identifier (UDI) to determine if your product is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact NIPRO Technical Services or your medical supply distributor to arrange for the return, replacement, or correction of the solutions.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Conductivity Standard Solution
Model / REF:
10001
10011
10021
10032
10040
10040c
10041
Lot Numbers:
14250616-1019106
14250616-1019107
50250624-1019120
50250624-1019119
14250616-1019108
50250522-1018643
50250624-1019121
15F250603-1018834
UDI:
00850016976000
00850016976093
00850016976369
00850016976352
00850016976311
00850016976376
00850016976192

Secondary standard solution used for the calibration of conductivity cells together with conductivity meters.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98030
Status: Active
Manufacturer: NIPRO Technical Services, Inc.
Sold By: Medical supply distributors
Manufactured In: United States
Units Affected: 499 units
Distributed To: Alabama, Arkansas, Arizona, California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Missouri, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.