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.
