09

Apr

2025

FDA Recall: Software bug, automated dispensing cabinet may result in a patient receiving more than the intended dose of medication

0

Company: CareFusion 303, Inc.
Date of Enforcement Report: 04/09/2025
Class II

PRODUCT

BD Pyxis” MedBank” Mini and BD Pyxis” MedBank” Tower, BD Pyxis” MedFlex, BD Pyxis” MedBank” MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.

Recall Number:

Z-1545-2025

REASON:

Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.

RECALLING FIRM/MANUFACTURER:

CareFusion 303, Inc.

VOLUME:

7357

DISTRIBUTION:

US Nationwide distribution: CA, TX, WI, CO, AK, VA, TN, WA, NC, NY, MS, FL, KS, MI, IN, MN, MT, KY, MO, UT, NJ, OH, PA, ND, OR, NE, SD, NV, OK, GA, MA, IA, HI, ME, AZ, IL, SC, LA, WV, AL, ID, NM, DC, NH, VT, CT, MD, AR, WY.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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