Recall Z-1120-2025— CareFusion 303, Inc.

Name: FDA recall Z-1120-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-08

Class II · Ongoing

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2025-01-08. FDA's recall record names no specific 510(k) clearance for this event. Product: (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. Reason: Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-01-08
Firm location: San Diego, CA, United States

Product description

(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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.