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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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Critical RiskFDA Device

Smiths Medical ASD Inc.: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

Agency Publication Date: August 6, 2020
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Affected Products

Product: Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

Product: Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.

Model Numbers: 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82. Software Version V6.0

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85912
Status: Active
Manufacturer: Smiths Medical ASD Inc.
Manufactured In: United States
Units Affected: 2 products (35616 units; 17019 units)
Agency Last Updated: September 12, 2020

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.