FDA-Device2025-02-19Class II

(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

CareFusion 303, Inc.
Hazard

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

Sold states
Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.
Affected count
137,741 total
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
(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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1119-2025

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