CareFusion 303, Inc. recalls (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedSt…

Recall date

January 8, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1120-2025

FDA classification

Class II

Brand / firm

CareFusion 303, Inc.

Sold / distributed

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

Why it was recalled

Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.

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) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338