Recall Z-1119-2025— CareFusion 303, Inc.
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) 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. Reason: 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.
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-08
- Firm location
- San Diego, CA, United States
Product description
(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
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.