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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
Medical Devices

BD Alaris Systems Manager and CCE Software Recalled for Software Bug

Agency Publication Date: March 13, 2025
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Summary

CareFusion 303, Inc. (BD) is recalling the BD Alaris Systems Manager and BD Care Coordination Engine (CCE) Infusion Adapter software. This recall is caused by a software bug that can result in outdated automated programming requests being sent to the pump's progressive care unit. No injuries or incidents have been reported in connection with this issue.

Risk

The software issue may cause the infusion pump to receive and execute outdated programming instructions. This could lead to incorrect medication doses or fluid delivery rates, which may result in patient harm if not corrected during the clinician's manual confirmation step.

What You Should Do

  1. This recall affects BD Alaris Systems Manager (REF 9601) Infusion Safety Management Software and BD Care Coordination Engine (CCE) Infusion Adapter software.
  2. Check your system to determine if you are using an affected software version. Affected versions include Alaris Systems Manager versions 12.5.1, 12.5.2, and several prior versions, as well as Care Coordination Engine version 1.7.2. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled software. Contact the manufacturer or your distributor to arrange for a software update, replacement, or correction.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BD Alaris Systems Manager, REF 9601 Infusion Safety Management Software
Model / REF:
9601
UDI:
10885403960123
10885403519666
10885403960116

Software versions: v12.5.1, v12.5.2, 4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3

Product: BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
UDI:
10885403510472

Software version: v1.7.2

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96323
Status: Active
Manufacturer: CareFusion 303, Inc.
Sold By: Hospital supply channels; Medical device distributors
Manufactured In: United States
Distributed To: Arizona, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 ยท 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.