CareFusion 303, Inc.

FDA Regulatory Profile

Summary

Total Recalls
164 (38 Class I)
510(k) Clearances
7
Inspections
13
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1028-2026Class IIBD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 13December 3, 2025
Z-0962-2026Class IIBD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD PyxisNovember 20, 2025
Z-1217-2026Class IIBD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with GuardrNovember 6, 2025
Z-0430-2026Class IBD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY OOctober 17, 2025
Z-0368-2026Class IIVarious models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 1390September 30, 2025
Z-0369-2026Class IIVarious models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00September 30, 2025
Z-0370-2026Class IIBD Pyxis Pro MedStation Main, REF: 1155-00September 30, 2025
Z-0367-2026Class IIVarious models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00September 30, 2025
Z-0371-2026Class IIAll Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00September 30, 2025
Z-0035-2026Class IBD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 MicronSeptember 11, 2025
Z-2321-2025Class IIIDescription/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYJuly 10, 2025
Z-2180-2025Class IBD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmarJuly 8, 2025
Z-2179-2025Class IBD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versionsJuly 8, 2025
Z-2477-2025Class IIBD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629May 8, 2025
Z-2017-2025Class IIProduct Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BMay 8, 2025
Z-1639-2025Class IIBD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM,March 11, 2025
Z-1550-2025Class IIBD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10March 11, 2025
Z-1545-2025Class IIBD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass March 11, 2025
Z-1304-2025Class IBD Alaris Systems Manager , REF 9601 Infusion Safety Management SoftwareFebruary 18, 2025
Z-1305-2025Class IBD Care Coordination Engine (CCE) Infusion Adapter, Safety Management SoftwareFebruary 18, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K243855BD Alaris Infusion System with Guardrails Suite MXApril 25, 2025
K211218BD Alaris System with Guardrails Suite MX v12.1.2July 21, 2023
K171957MaxZero Extension Sets with Needless ConnectorJuly 19, 2017
K163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemJune 22, 2017
K133532ALARIS SYSTEM WITH GUARDRAILS SUITE MXAugust 21, 2014
K110535ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTIONMarch 26, 2012
K110809WIRELESS MONITORING SYSTEMJuly 5, 2011