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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: Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

Agency Publication Date: April 30, 2020
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Affected Products

Product: Prismaflex System, Prismaflex Control Unit

Product Code: 107493 GTIN 07332414073718

Lot Numbers:
107493
Product: Prismaflex System, Prismaflex Control Unit

Product Code: 113081; GTIN 07332414105266

Lot Numbers:
113081
Product: Prismaflex System, Prismaflex Control Unit

Product Code: 114870; GTIN 07332414115395

Lot Numbers:
114870
Product: Prismaflex System, Prismaflex Control Unit

Product Code:115269; GTIN 07332414117702

Lot Numbers:
115269
Product: Prismaflex System, Prismaflex Control Unit

Product Code:955542; GTIN 07332414124236

Lot Numbers:
955542
Product: Prismaflex System, Prismaflex Control Unit

Product Code:955792; GTIN 07332414126766

Lot Numbers:
955792

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85007
Status: Resolved
Manufacturer: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 6 products (4946 units; 1225 units; 2471; 555; 626; 133)

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.

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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.