FDA-Device2025-02-19Class II
(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
CareFusion 303, Inc.
Hazard
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
Sold states
Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia.
Affected count
193067
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
(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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1120-2025Don't want to check this manually?
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