CareFusion 303, Inc.: BD Pyxis MedBank MedPass Software Recalled for Duplicate Medication Risk

Agency Publication Date: September 28, 2023

Summary

CareFusion 303, Inc. is recalling 37 units of BD Pyxis MedBank MedPass Software (REF: 139088-01) due to a software defect that may incorrectly show a medication as available for dispensing after it has already been given to a patient. This error affects software versions prior to v1.2.3.23 and can lead to healthcare providers accidentally administering a double dose of medication. This recall was initiated voluntarily by the firm to address the safety risk associated with automated dispensing cabinets.

Risk

The software fails to update the patient's record immediately after a timed dose is dispensed, which could cause a patient to receive a duplicate dose of medication, potentially leading to serious adverse health consequences or overdose.

What You Should Do

Identify your software version by checking the system information on your BD Pyxis MedBank MedPass unit for versions prior to v1.2.3.23.
Locate the UDI-DI 10885403513817 and REF: 139088-01 on your device documentation to confirm it is part of the affected 37 units.
Carefully monitor medication administration logs manually to ensure that timed doses are not duplicated while using the affected software versions.
Contact CareFusion 303, Inc. or your BD representative immediately to arrange for a software update to version v1.2.3.23 or later.
Healthcare providers with questions regarding the safety or functionality of their dispensing cabinets should contact CareFusion 303, Inc. directly at their San Diego headquarters.
For additional information or to report any adverse events, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Software update and manufacturer notification

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

Affected Products

Product: BD Pyxis MedBank MedPass Software

Model / REF:

REF: 139088-01

UPC Codes:

10885403513817

Lot Numbers:

Software versions prior to v1.2.3.23

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92967

Status: Active

Manufacturer: CareFusion 303, Inc.

Sold By: Direct distribution to healthcare facilities

Manufactured In: United States

Units Affected: 37

Distributed To: Florida, Michigan, Kansas

Agency Last Updated: May 5, 2025

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 · 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.

Summary

What You Should Do

Identify your software version by checking the system information on your BD Pyxis MedBank MedPass unit for versions prior to v1.2.3.23.

Locate the UDI-DI 10885403513817 and REF: 139088-01 on your device documentation to confirm it is part of the affected 37 units.

Carefully monitor medication administration logs manually to ensure that timed doses are not duplicated while using the affected software versions.

Contact CareFusion 303, Inc. or your BD representative immediately to arrange for a software update to version v1.2.3.23 or later.

Healthcare providers with questions regarding the safety or functionality of their dispensing cabinets should contact CareFusion 303, Inc. directly at their San Diego headquarters.

For additional information or to report any adverse events, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.