Carefusion 303, Inc.
Carefusion 303, Inc. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2025, with 173 FDA device recalls on record.
Top product codes for Carefusion 303, Inc.
FDA recalls by Carefusion 303, Inc.
10 most recent of 173- Z-2303-2026 — BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
- Z-2301-2026 — BD Pyxis Mini Main REF: 349 Medication cabinet
- Z-2300-2026 — BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
- Z-2298-2026 — BD Pyxis MedStation ES REF: 323 Medication cabinet
- Z-2299-2026 — BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet
- Z-2297-2026 — BD Pyxis MedStation 4000 REF: 303 Medication cabinet
- Z-2304-2026 — BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet
- Z-2302-2026 — BD Pyxis MedStation ES Tower REF: 352 Medication cabinet
- Z-1645-2026 — BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
- Z-1028-2026 — BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Carefusion 303, Inc.
- K243855 — BD Alaris Infusion System with Guardrails Suite MX
- K211218 — BD Alaris System with Guardrails Suite MX v12.1.2
- K171957 — MaxZero Extension Sets with Needless Connector
- K163316 — Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
- K133532 — ALARIS SYSTEM WITH GUARDRAILS SUITE MX
- K110535 — ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
- K110809 — WIRELESS MONITORING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.