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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

Baxter Healthcare Corporation: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

Agency Publication Date: December 22, 2022
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Affected Products

Product: Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

UDI-DI: 07332414123055; Product Code: 114745L; All lot numbers from C419128801-C422128401

Lot Numbers:
114745L
numbers
Product: Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

a. UDI-DI: 07332414124076; Product Code: 114746L; All lot numbers from C421221401-C422228501. b. UDI-DI: 07332414126209; Product Code: 114746M; All lot numbers from C422218601-C422219901

Lot Numbers:
114746L
numbers
114746M
numbers
Product: Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

No distribution in the USA. Product Code: 114749M; All lot numbers from C422202401 C422227201

Lot Numbers:
114749M
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91223
Status: Active
Manufacturer: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 3 products (14,053,824 units; 6,338,280 units; 1,140,096 units)

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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.