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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: Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

Agency Publication Date: November 4, 2019
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Affected Products

Product: Prismaflex Control Unit, software versions below 7.21

Product Code: 115269 (GTIN: 07332414117702), 955542 GTIN: 07332414124236); All Lot numbers

Lot Numbers:
115269
numbers
Product: Prismaflex Control Unit, software versions below 7.21

Product Code: 6023014700; All Lot numbers; GTIN: 07332414073718.

Lot Numbers:
6023014700
numbers
Product: Prismaflex Control Unit, software versions below 7.21

Product Code: 114870; All Lot numbers; GTIN: 07332414115395. Device not distributed in the US.

Lot Numbers:
114870
numbers
Product: Prismaflex Control Unit, software versions below 7.21

Product Code: 107493; All Lot numbers; GTIN: 07332414073718

Lot Numbers:
107493
numbers
Product: Prismaflex Control Unit, software versions below 7.21

Product Code: 113081; All Lot numbers; GTIN: 07332414105266

Lot Numbers:
113081
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83852
Status: Active
Manufacturer: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 5 products (2,760 units; 986 units; 988 units; 1,014 units; 336 units)

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.