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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
Medical Devices/Monitoring Devices

CareFusion 303, Inc.: BD Alaris System Manager Recalled Due to Server Connection Software Issue

Agency Publication Date: July 3, 2024
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Summary

CareFusion 303, Inc. has recalled 168 units of the BD Alaris System Manager (Model REF: 9601) due to a software issue that prevents the PC unit from connecting to the server. This defect disrupts wireless data transmission both to and from the server, which is critical for managing the Alaris infusion system. Consumers should contact their healthcare provider or the manufacturer for specific instructions on addressing this software failure.

Risk

The software failure prevents the Alaris PC unit from communicating with the central server, which could lead to delays or errors in wireless data transmission and impact infusion system monitoring. This connectivity issue may hinder the delivery of updated medical information or monitoring data required for patient care.

What You Should Do

  1. Identify your device by checking for the BD Alaris System Manager (REF: 9601) and verify the software version is 12.5.1.
  2. Check the Universal Device Identifier (UDI) on your software or documentation to see if it matches 10885403960123.
  3. If you have the affected software version, contact CareFusion 303, Inc. at their San Diego headquarters or your facility's technical support team for instructions on software updates or patches.
  4. Contact your healthcare provider or the manufacturer for further instructions regarding the safe continued use of the device and any potential remedies.
  5. For more information or to report additional issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer software correction or instruction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BD Alaris System Manager (Software versions 12.5.1)
Model / REF:
REF: 9601
UPC Codes:
10885403960123

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94718
Status: Active
Manufacturer: CareFusion 303, Inc.
Sold By: Medical facilities; Direct distribution
Manufactured In: United States
Units Affected: 168 software version
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin
Agency Last Updated: August 29, 2024

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.