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CareFusion 303, Inc.

159 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP a recall (Z-1192-2023)CareFusion 303, Inc.2023-03-01
BD Pyxis MedBank System - Product Label/labeling pending recall (Z-0928-2023)CareFusion 303, Inc.2023-01-10
BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers inc recall (Z-1785-2022)CareFusion 303, Inc.2022-09-23
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Mo recall (Z-2882-2020)CareFusion 303, Inc.2020-09-04
Alaris System PC Unit Model 8015 recall (Z-2909-2020)CareFusion 303, Inc.2020-09-04
PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015L recall (Z-2910-2020)CareFusion 303, Inc.2020-09-04
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare c recall (Z-2822-2020)CareFusion 303, Inc.2020-08-19
Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcar recall (Z-2823-2020)CareFusion 303, Inc.2020-08-19
Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare ca recall (Z-2824-2020)CareFusion 303, Inc.2020-08-19
Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare recall (Z-2825-2020)CareFusion 303, Inc.2020-08-19
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide train recall (Z-2826-2020)CareFusion 303, Inc.2020-08-19
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system recall (Z-2716-2020)CareFusion 303, Inc.2020-08-06
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system recall (Z-2717-2020)CareFusion 303, Inc.2020-08-06
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system recall (Z-2718-2020)CareFusion 303, Inc.2020-08-06
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system recall (Z-2719-2020)CareFusion 303, Inc.2020-08-06
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system recall (Z-2720-2020)CareFusion 303, Inc.2020-08-06
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system recall (Z-2721-2020)CareFusion 303, Inc.2020-08-06
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring syste recall (Z-2722-2020)CareFusion 303, Inc.2020-08-06
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system recall (Z-2723-2020)CareFusion 303, Inc.2020-08-06
Alaris Pump Module Model 8100 recall (Z-2736-2020)CareFusion 303, Inc.2020-08-06
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system recall (Z-2740-2020)CareFusion 303, Inc.2020-08-06
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system recall (Z-2741-2020)CareFusion 303, Inc.2020-08-06
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) recall (Z-1359-2020)CareFusion 303, Inc.2020-03-05
CareFusion Alaris Pump Module, Model 8100 recall (Z-1360-2020)CareFusion 303, Inc.2020-03-05
CareFusion Alaris Syringe Module, Model 8110 recall (Z-1361-2020)CareFusion 303, Inc.2020-03-05
CareFusion Alaris PCA Module, Model 8120 recall (Z-1362-2020)CareFusion 303, Inc.2020-03-05
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic recall (Z-1768-2019)CareFusion 303, Inc.2019-07-16
Alaris PC Unit, Model 8015 recall (Z-2671-2017)CareFusion 303, Inc.2017-06-19
Alaris Pump Module model 8100 recall (Z-2700-2017)CareFusion 303, Inc.2017-06-19
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305 recall (Z-1464-2017)CareFusion 303, Inc.2017-02-28
MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension recall (Z-1482-2017)CareFusion 303, Inc.2017-02-28
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. T recall (Z-0950-2017)CareFusion 303, Inc.2017-01-18
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 recall (Z-1239-2016)CareFusion 303, Inc.2016-03-24
Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accesso recall (Z-0814-2016)CareFusion 303, Inc.2016-02-16
Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon recall (Z-0455-2016)CareFusion 303, Inc.2015-12-21
Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medi recall (Z-0445-2016)CareFusion 303, Inc.2015-12-17
SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications throug recall (Z-0221-2016)CareFusion 303, Inc.2015-11-05
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Hou recall (Z-2362-2015)CareFusion 303, Inc.2015-08-14
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris recall (Z-1811-2015)CareFusion 303, Inc.2015-06-16
Alaris PC units, Model No. 8015. Infusion pump. recall (Z-1311-2015)CareFusion 303, Inc.2015-03-23
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are use recall (Z-1053-2015)CareFusion 303, Inc.2015-02-04
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 recall (Z-2025-2014)CareFusion 303, Inc.2014-07-09
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay recall (Z-1567-2014)CareFusion 303, Inc.2014-05-14
SmartSite Extension Set, Model No. 20029E, intravascular administration set. recall (Z-1459-2014)CareFusion 303, Inc.2014-04-16
Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230 recall (Z-0931-2014)CareFusion 303, Inc.2014-02-04
SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are st recall (Z-0925-2014)CareFusion 303, Inc.2014-02-03
Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode s recall (Z-0534-2014)CareFusion 303, Inc.2013-12-20
SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The recall (Z-0450-2014)CareFusion 303, Inc.2013-12-04
VersaSafe Extension Set, Model No. 21000M-007 recall (Z-0435-2014)CareFusion 303, Inc.2013-12-03
SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets a recall (Z-2279-2013)CareFusion 303, Inc.2013-09-26
CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer recall (Z-2281-2013)CareFusion 303, Inc.2013-09-26
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. recall (Z-2285-2013)CareFusion 303, Inc.2013-09-26
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly recall (Z-1835-2013)CareFusion 303, Inc.2013-08-02
CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood pr recall (Z-0832-2013)Carefusion 303 Inc2013-02-15
Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. recall (Z-2205-2012)CareFusion 303, Inc.2012-08-17
Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended fo recall (Z-2185-2012)CareFusion 303, Inc.2012-08-15
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only. recall (Z-2076-2012)CareFusion 303, Inc.2012-07-26
Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and p recall (Z-0876-2012)CareFusion 303, Inc.2012-01-26
MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Prod recall (Z-2707-2011)Carefusion 303, Inc.2011-06-29
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