CareFusion 303, Inc. recalls (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES…
- Recall date
- January 8, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1119-2025
- FDA classification
- Class II
- Brand / firm
- CareFusion 303, Inc.
- Sold / distributed
- Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.
Why it was recalled
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
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
(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
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