Company ยท US
CareFusion 303, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2025. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
175recalls (13 in 12 months)
90recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BRY | Cabinet, Table And Tray, Anesthesia | 85 |
| FRN | Pump, Infusion | 65 |
| FPA | Set, Administration, Intravascular | 23 |
| PHC | Infusion Safety Management Software | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| MEA | Pump, Infusion, Pca | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 2025 | K243855 | BD Alaris Infusion System with Guardrails Suite MX Carefusion 303, Inc. | FRN |
| Jul 21, 2023 | K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 Carefusion 303, Inc. | FRN |
| Jul 19, 2017 | K171957 | MaxZero Extension Sets with Needless Connector Carefusion 303, Inc. | FPA |
| Jun 22, 2017 | K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System Carefusion 303, Inc. | DSA |
| Aug 21, 2014 | K133532 | ALARIS SYSTEM WITH GUARDRAILS SUITE MX Carefusion 303, Inc. | FRN |
| Mar 26, 2012 | K110535 | ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION Carefusion 303, Inc. | FRN |
| Jul 5, 2011 | K110809 | WIRELESS MONITORING SYSTEM Carefusion 303, Inc., GB | DRG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2026 | CareFusion 303, Inc. BD Pyxis MedBank Mini
REF: 1147-00
Medication cabinet Open, Classified |
BRY | None listed |
| Jun 3, 2026 | CareFusion 303, Inc. BD Pyxis MedBank Tower
REF: 1145-00
Medication cabinet Open, Classified |
BRY | None listed |
| Jun 3, 2026 | CareFusion 303, Inc. BD Pyxis MedStation ES Tower
REF: 352
Medication cabinet Open, Classified |
BRY | None listed |
| Jun 3, 2026 | CareFusion 303, Inc. BD Pyxis Mini Main
REF: 349
Medication cabinet Open, Classified |
BRY | None listed |
| Jun 3, 2026 | CareFusion 303, Inc. BD Pyxis Anesthesia Station 4000
REF: 338
Medication cabinet Open, Classified |
BRY | None listed |
| Jun 3, 2026 | CareFusion 303, Inc. BD Pyxis Anesthesia Station ES
REF: 327
Medication cabinet Open, Classified |
BRY | None listed |
| Jun 3, 2026 | CareFusion 303, Inc. BD Pyxis MedStation ES
REF: 323
Medication cabinet Open, Classified |
BRY | None listed |
| Jun 3, 2026 | CareFusion 303, Inc. BD Pyxis MedStation 4000
REF: 303
Medication cabinet Open, Classified |
BRY | None listed |
| Mar 26, 2026 | CareFusion 303, Inc. BD Alaris" System with Guardrails" Suite MX with Point of Care Unit Open, Classified |
FRN | K023264 K041241 +4 |
| Jan 29, 2026 | CareFusion 303, Inc. BD Alaris" Pump Module model 8100
UDI-DI code: 10885403810046
The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent admi Open, Classified |
FRN | K211218 |
| Jan 8, 2026 | CareFusion 303, Inc. 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, 1364 Open, Classified |
BRY | None listed |
| Dec 19, 2025 | CareFusion 303, Inc. BD Pyxis MedStation ES, REF: 323,
BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324,
BD Pyxis MedStation ES Tower, REF: 352,
BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00,
BD Pyxis Pro 7- Drawe Open, Classified |
BRY | None listed |
| Nov 20, 2025 | CareFusion 303, Inc. BD Alaris infusion Pump Module 8100, REF: 8100;
KIT, BEZEL ASSY 8100BD, REF: 49000437;
KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270.
Used with the following new and updated documents: BD Alaris Infu Open, Classified |
FRN | K211218 |
| Oct 27, 2025 | CareFusion 303, Inc. All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 Open, Classified |
BRY | None listed |
| Oct 27, 2025 | CareFusion 303, Inc. BD Pyxis Pro MedStation Main, REF: 1155-00 Open, Classified |
BRY | None listed |
| Oct 27, 2025 | CareFusion 303, Inc. Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and
1152-00 Open, Classified |
BRY | None listed |
| Oct 27, 2025 | CareFusion 303, Inc. Various models of BD Pyxis MedFlex, Reference numbers: 1119-00
1139-00
139038-01
139039-01
139040-01
139041-01
139043-01
139044-01
139045-01
139046-01
139049-01
139051-01
139052-01
139053-01
139054-0 Open, Classified |
BRY | None listed |
| Oct 27, 2025 | CareFusion 303, Inc. Various models of BD Pyxis Medbank: Reference numbers: 1137-00
1145-00
1146-00
1147-00
1148-00
138902-01
138903-01
138905-01
138906-01
138907-01
138908-01
138909-01
138910-01
138911-01
138912-01
138 Open, Classified |
BRY | None listed |
| Oct 8, 2025 | CareFusion 303, Inc. BD Alaris Pump Infusion Sets for the following reference numbers:
C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site
10015414, 180 Micron Filter
2447-0007, Ball Valve Smar Open, Classified |
FPA | K022209 |
| Aug 28, 2025 | CareFusion 303, Inc. BD Pyxis
Product Name / UDI-DI code / Catalog No.
BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303
BD Pyxis" MedStation" ES Tower / 10885403512674 / 352
BD Pyxis" Anesthesia Station ES / 10885 Open, Classified |
BRY | None listed |
| Aug 13, 2025 | CareFusion 303, Inc. Description/REF:
BD PYXIS MEDBANK MINI 1FH-1FM/169-137,
BD PYXIS MEDBANK MINI 4HM/169-113,
BD PYXIS MEDBANK MINI 4HH/169-112,
BD PYXIS MEDBANK MINI 3HH-1HM/169-111,
BD PYXIS MEDBANK MINI 3HH-1 Open, Classified |
BRY | None listed |
| Aug 6, 2025 | CareFusion 303, Inc. BD Alaris Pump Infusion Sets
REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV;
REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Val Open, Classified |
FRN | K022209 |
| Aug 6, 2025 | CareFusion 303, Inc. BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions Open, Classified |
FRN | K211218 |
| Jun 24, 2025 | CareFusion 303, Inc. Product Name [REF]:
Supply Server,
CCE Enterprise SW Site License (2-5),
BD Pyxis Logistics [806],
BD Pyxis MedStation 4000 Main 10885403512629 [303],
BD Pyxis MedStation ES Tower 10885403512674 [352] Open, Classified |
BRY | None listed |
| Apr 18, 2025 | CareFusion 303, Inc. BD PYXIS MEDBANK (Name, REF):
MEDPASS MODULE, 139088-01;
MINI 1FH-1FM, 169-137;
MINI 1HH-1FH-1HM, 169-101;
MINI 1HH-1HM-1FM, 169-102;
MINI 2FH, 138902-01;
MINI 2FH, 169-104;
MINI 2FM, 169-105;
MINI 2H Open, Classified |
BRY | None listed |
| Apr 11, 2025 | CareFusion 303, Inc. MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD P Open, Classified |
BRY | None listed |
| Apr 9, 2025 | CareFusion 303, Inc. BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qua Open, Classified |
BRY | None listed |
| Apr 9, 2025 | CareFusion 303, Inc. BD Pyxis MedBank CUBIE Replenishment Station
Product / Material ID
BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01
BD PYXIS MEDBANK TWR MN CR-12HH- Open, Classified |
BRY | None listed |
| Mar 17, 2025 | CareFusion 303, Inc. BD Pyxis:
Anesthesia Station ES, REF: 327,
MedStation ES, REF: 323,
MedStation ES Tower, REF: 352,
CII Safe ES, REF: 1116-00,
CII Safe ES Desktop PC, REF: 1156-00,
CII Safe ES Desktop PC, Wired SCNR, Open, Classified |
BRY | None listed |
| Mar 13, 2025 | CareFusion 303, Inc. BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software Open, Classified |
PHC | K211218 |
| Mar 13, 2025 | CareFusion 303, Inc. BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software Open, Classified |
PHC | K211218 |
| Feb 24, 2025 | CareFusion 303, Inc. BD Alaris Pump Module REF 8100
The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, ped Open, Classified |
FRN | K211218 |
| Feb 21, 2025 | CareFusion 303, Inc. 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK Open, Classified |
BRY | None listed |
| Feb 21, 2025 | CareFusion 303, Inc. 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX Open, Classified |
BRY | None listed |
| Feb 21, 2025 | CareFusion 303, Inc. 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1F Open, Classified |
BRY | None listed |
| Feb 21, 2025 | CareFusion 303, Inc. BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides. Open, Classified |
BRY | None listed |
| Feb 21, 2025 | CareFusion 303, Inc. 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 20 Open, Classified |
BRY | None listed |
| Feb 21, 2025 | CareFusion 303, Inc. BD Pyxis MedFlex 2.0 REF 1139-00
Bio-ID Spare Parts REF 353200-01
The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a Open, Classified |
BRY | None listed |
| Feb 11, 2025 | CareFusion 303, Inc. BD Pyxis MedStation 4000 REF: 303.
Intended to securely store and dispense medications to a qualified and authorized healthcare provider. Open, Classified |
BRY | None listed |
| Feb 11, 2025 | CareFusion 303, Inc. BD Pyxis MedStation Auxiliary 4000 REF: 306.
Intended to securely store and dispense medications to a qualified and authorized healthcare provider. Open, Classified |
BRY | None listed |
| Feb 11, 2025 | CareFusion 303, Inc. BD Pyxis MedStation Auxiliary ES REF: 324.
Intended to securely store and dispense medications to a qualified and authorized healthcare provider. Open, Classified |
BRY | None listed |
| Feb 11, 2025 | CareFusion 303, Inc. BD Pyxis MedStation ES (Med ES Main) REF: 323.
Intended to securely store and dispense medications to a qualified and authorized healthcare provider. Open, Classified |
BRY | None listed |
| Feb 7, 2025 | CareFusion 303, Inc. (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 Open, Classified |
BRY | None listed |
| Feb 7, 2025 | CareFusion 303, Inc. (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 Open, Classified |
BRY | None listed |
| Jan 30, 2025 | CareFusion 303, Inc. BD Pyxis MedStation ES AUX Tower REF 343
BD Pyxis " MedStation 4000 AUX Tower REF 314
The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended Open, Classified |
BRY | None listed |
| Jan 17, 2025 | CareFusion 303, Inc. BD Pyxis Med 4000 Auxiliary (AUX), REF 314 Open, Classified |
BRY | None listed |
| Jan 17, 2025 | CareFusion 303, Inc. BD Pyxis Med ES Auxiliary (AUX), REF 343 Open, Classified |
BRY | None listed |
| Jan 17, 2025 | CareFusion 303, Inc. BD Pyxis MedStation 4000 AUX, REF 306 Open, Classified |
BRY | None listed |
| Jan 17, 2025 | CareFusion 303, Inc. BD Pyxis MedStation 4000 Main, REF 303 Open, Classified |
BRY | None listed |
| Jan 17, 2025 | CareFusion 303, Inc. BD Pyxis MedStation ES AUX, REF 324 Open, Classified |
BRY | None listed |
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