Feb

2025

FDA Recall: Software Issue Leading to Wrong Therapy or Unauthorized Access

Company: CareFusion 303, Inc.
Date of Enforcement Report: 2/07/2025
Class II

PRODUCT

(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00

Recall Number:

Z-1119-2025

REASON:

Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues

RECALLING FIRM/MANUFACTURER:

CareFusion 303, Inc.

VOLUME OF PRODUCT IN COMMERCE:

137,741 total

DISTRIBUTION:

Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.

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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FDA Recall: Software Issue Leading to Wrong Therapy or Unauthorized Access

Allison Pate

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