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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

NxStage Medical, Inc.: Certain lots were mislabeled with incorrect product number.

Agency Publication Date: June 2, 2019
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Affected Products

Product: NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Lot Number: Q1811792 Exp Date: 11/1/2020

Lot Numbers:
Number
Product: NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Lot Number: Q1811789 & Q1811790 Exp Date: 11/1/2020

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82693
Status: Resolved
Manufacturer: NxStage Medical, Inc.
Manufactured In: United States
Units Affected: 2 products (1998 units; 3,940 units)

Were You Affected by This Recall?

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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 · 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.