| 30 Apr 2026 | BD Pyxis MedStation 4000 REF: 303 Medication cabinet | Device | Class II | 8 | Ongoing |
| 11 Feb 2026 | BD Alaris" System with Guardrails" Suite MX with Point of Care Unit | Device | Class II | 1 | Ongoing |
| 3 Dec 2025 | 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,… | Device | Class II | 1 | Ongoing |
| 20 Nov 2025 | 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- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main, REF: 1155-00, BD Pyxis CII Safe ES, REF: 1116-00 | Device | Class II | 1 | Ongoing |
| 6 Nov 2025 | 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 administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration:… | Device | Class II | 1 | Ongoing |
| 17 Oct 2025 | 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 Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part:… | Device | Class I | 1 | Ongoing |
| 30 Sep 2025 | 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 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 138919-01 138920-01 138921-01 138922-01 138923-01 138924-01… | Device | Class II | 5 | Ongoing |
| 11 Sep 2025 | 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 SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites 10012645, Back Check Valve, Non-vented,… | Device | Class I | 1 | Ongoing |
| 10 Jul 2025 | 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-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-2HM/169-108, BD PYXIS MEDBANK MINI… | Device | Class III | 1 | Ongoing |
| 8 Jul 2025 | BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions | Device | Class I | 2 | Ongoing |
| 8 May 2025 | 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], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (Main) 10885403512667 [323], MD BD Pyxis… | Device | Class II | 1 | Ongoing |
| 8 May 2025 | 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 / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323 BD Pyxis" CII Safe ES / 10885403512605 / 1116-00… | Device | Class II | 1 | Ongoing |
| 11 Mar 2025 | 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 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI 2HH-1FM, 138906-01; MINI 3HH-1FG, 169-110; MINI… | Device | Class II | 1 | Ongoing |
| 11 Mar 2025 | 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 qualified and authorized user in a clinical settings. | Device | Class II | 1 | Ongoing |
| 11 Mar 2025 | 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-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD PYXIS MEDBANK TWR MN CR-14HH-P / 155144-01 BD… | Device | Class II | 1 | Ongoing |
| 18 Feb 2025 | BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software | Device | Class I | 2 | Ongoing |
| 6 Feb 2025 | 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, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00… | Device | Class II | 1 | Ongoing |
| 23 Jan 2025 | 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, pediatric, and neonatal patients through clinically accepted routes of administration | Device | Class II | 1 | Ongoing |
| 23 Jan 2025 | 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 qualified and authorized user in a clinical setting. | Device | Class II | 1 | Ongoing |
| 10 Jan 2025 | 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. | Device | Class II | 1 | Ongoing |
| 8 Jan 2025 | (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 | Device | Class II | 1 | Ongoing |
| 8 Jan 2025 | (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 | Device | Class II | 1 | Ongoing |
| 8 Jan 2025 | 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 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS MEDBANK MN 200 CR-4HH-P 139020-01 BD… | Device | Class II | 4 | Ongoing |
| 14 Nov 2024 | BD Pyxis MedStation ES, REF: 323 | Device | Class II | 3 | Ongoing |
| 15 Aug 2024 | Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system | Device | Class II | 5 | Ongoing |
| 9 Jul 2024 | BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system | Device | Class II | 2 | Ongoing |
| 24 Jun 2024 | BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9 | Device | Class II | 19 | Ongoing |
| 21 May 2024 | BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units | Device | Class II | 1 | Ongoing |
| 13 May 2024 | BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEDBANK MINI 2FH/ 169-104, MEDBANK MINI 2FM/ 169-105, MEDBANK MINI 2HH-1FH/ 169-106, MEDBANK MINI 2HH-1FM/ 169-107, MEDBANK… | Device | Class II | 2 | Ongoing |
| 2 May 2024 | BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII… | Device | Class II | 1 | Ongoing |
| 15 Apr 2024 | BD Pyxis MedStation ES, REF: 323, Medication Cabinet | Device | Class II | 6 | Ongoing |
| 23 Feb 2024 | BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provider. | Device | Class II | 4 | Ongoing |
| 1 Feb 2024 | BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352; | Device | Class II | 1 | Ongoing |
| 5 Oct 2023 | 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 PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1FH- 1HM, REF: 169-101; BD PYXIS MEDBANK… | Device | Class II | 1 | Ongoing |
| 15 Sep 2023 | BD Alaris PCU REF 8015 | Device | Class I | 3 | Ongoing |
| 6 Sep 2023 | BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01 | Device | Class II | 1 | Ongoing |
| 18 Aug 2023 | BD Pyxis MedBank MedPass Software, REF: 139088-01 | Device | Class II | 1 | Ongoing |
| 22 May 2023 | BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-203-01, 111-204-01, 111-205-01,… | Device | Class II | 1 | Ongoing |
| 5 Apr 2023 | BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01 | Device | Class II | 1 | Ongoing |
| 5 Apr 2023 | BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352 | Device | Class II | 1 | Ongoing |
| 14 Feb 2023 | BD Pyxis MedStation ES (Med ES Main), REF 323 | Device | Class II | 6 | Ongoing |
| 14 Feb 2023 | BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system… | Device | Class II | 1 | Ongoing |
| 14 Feb 2023 | 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 to securely store and dispense medications to a qualified and authorized healthcare provider. | Device | Class II | 1 | Ongoing |
| 24 Jan 2023 | Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255 | Device | Class II | 1 | Ongoing |
| 12 Dec 2022 | BD Pyxis MedBank System - Product Label/labeling pending | Device | Class II | 1 | Ongoing |
| 24 May 2022 | BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 . MedBank 200 Main operating with Windows 7 . MedBank 500 Main operating with Windows 7. An automated dispensing cabinet intended to securely store and dispense medications to… | Device | Class II | 1 | Ongoing |
| 3 Mar 2021 | BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439. | Device | Class I | 1 | Ongoing |
| 4 Aug 2020 | BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and… | Device | Class II | 1 | Ongoing |
| 4 Aug 2020 | BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652 | Device | Class I | 1 | Ongoing |
| 4 Aug 2020 | Alaris System PC Unit Model 8015 | Device | Class I | 2 | Ongoing |
| 4 Aug 2020 | BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump. | Device | Class I | 1 | Ongoing |
| 30 Jun 2020 | Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. | Device | Class II | 5 | Ongoing |
| 30 Jun 2020 | Alaris System PC Unit Model 8000 modular infusion pump and monitoring system | Device | Class I | 2 | Terminated |
| 30 Jun 2020 | Alaris Pump Module Model 8100 | Device | Class I | 1 | Terminated |
| 30 Jun 2020 | Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system | Device | Class I | 8 | Terminated |
| 4 Feb 2020 | CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) | Device | Class I | 4 | Ongoing |
| 1 Jul 2019 | Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933 | Device | Class II | 1 | Terminated |
| 20 Apr 2018 | Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00 -VersaSafe… | Device | Class II | 1 | Terminated |
| 13 Apr 2018 | Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alaris Pump Module serviced with LVP Mechanism… | Device | Class I | 1 | Terminated |
| 17 Nov 2017 | Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The modules are… | Device | Class II | 2 | Terminated |
| 6 Nov 2017 | Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components… | Device | Class II | 1 | Terminated |
| 9 Aug 2017 | Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module… | Device | Class II | 1 | Ongoing |
| 30 Jun 2017 | VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patient’s artery or vein. | Device | Class II | 1 | Terminated |
| 12 Jun 2017 | Alaris PC Unit, Model 8015 | Device | Class II | 1 | Terminated |
| 12 Jun 2017 | Alaris Pump Module model 8100 | Device | Class II | 1 | Terminated |
| 20 Feb 2017 | MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305 | Device | Class II | 1 | Terminated |
| 20 Feb 2017 | MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention… | Device | Class II | 1 | Terminated |
| 2 Dec 2016 | Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through… | Device | Class I | 1 | Terminated |
| 17 Nov 2016 | SmartSite Add-On Bag Access Device, Model No. 10013365 | Device | Class II | 1 | Terminated |
| 1 Nov 2016 | Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System. | Device | Class II | 1 | Terminated |
| 8 Aug 2016 | Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central… | Device | Class II | 1 | Terminated |
| 12 May 2016 | Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System. | Device | Class II | 1 | Terminated |
| 24 Mar 2016 | Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. | Device | Class II | 1 | Terminated |
| 15 Feb 2016 | Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007 | Device | Class II | 1 | Terminated |
| 12 Feb 2016 | Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 | Device | Class II | 1 | Terminated |
| 15 Jan 2016 | Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000… | Device | Class II | 1 | Terminated |
| 12 Nov 2015 | Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). | Device | Class II | 1 | Terminated |
| 5 Nov 2015 | Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. | Device | Class II | 1 | Terminated |
| 9 Oct 2015 | SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. | Device | Class II | 1 | Terminated |
| 21 Jul 2015 | Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100. | Device | Class I | 1 | Terminated |
| 13 May 2015 | Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit. | Device | Class II | 1 | Terminated |
| 12 Mar 2015 | Alaris PC units, Model No. 8015. Infusion pump. | Device | Class II | 1 | Terminated |
| 13 Jan 2015 | SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It… | Device | Class II | 1 | Terminated |
| 17 Jun 2014 | SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458 | Device | Class II | 1 | Terminated |
| 23 Apr 2014 | Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous… | Device | Class I | 1 | Terminated |
| 19 Mar 2014 | SmartSite Extension Set, Model No. 20029E, intravascular administration set. | Device | Class II | 1 | Terminated |
| 22 Jan 2014 | SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle. | Device | Class II | 1 | Terminated |
| 16 Jan 2014 | Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230. | Device | Class II | 1 | Terminated |
| 5 Dec 2013 | Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under… | Device | Class I | 1 | Terminated |
| 8 Nov 2013 | VersaSafe Extension Set, Model No. 21000M-007 | Device | Class II | 1 | Terminated |
| 8 Nov 2013 | SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. | Device | Class II | 1 | Terminated |
| 30 Aug 2013 | CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It… | Device | Class II | 1 | Terminated |
| 30 Aug 2013 | SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets… | Device | Class II | 1 | Terminated |
| 30 Aug 2013 | SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. | Device | Class II | 1 | Terminated |
| 17 Jun 2013 | Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in today’s growing professional healthcare… | Device | Class I | 1 | Terminated |
| 20 Dec 2012 | CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein. | Device | Class II | 1 | Terminated |
| 29 Jun 2012 | Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV),… | Device | Class I | 1 | Terminated |
| 15 Jun 2012 | Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of… | Device | Class I | 1 | Terminated |
| 25 May 2012 | Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only. | Device | Class I | 1 | Terminated |