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CareFusion 303 Recalls
173 recalls on record · August 1, 2012 to June 10, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 12, 2020Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Hazard: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
August 12, 2020Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Hazard: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
August 12, 2020Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Hazard: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
August 12, 2020Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
Hazard: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
August 12, 2020Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Hazard: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
March 11, 2020Medical DevicesFDA
CareFusion 303, Inc. recalls CareFusion Alaris PCA Module, Model 8120
Hazard: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
March 11, 2020Medical DevicesFDA
CareFusion 303, Inc. recalls CareFusion Alaris Syringe Module, Model 8110
Hazard: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
March 11, 2020Medical DevicesFDA
CareFusion 303, Inc. recalls CareFusion Alaris Pump Module, Model 8100
Hazard: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
March 11, 2020Medical DevicesFDA
CareFusion 303, Inc. recalls CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Hazard: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
September 11, 2019Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Hazard: Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
July 24, 2019Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following produ
Hazard: The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.
November 14, 2018Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusi
Hazard: Complaints where users were unable to prime the administration set.
June 13, 2018Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a
Hazard: Reports of incorrect priming volume due to manufacturing with incorrect tubing.
January 17, 2018Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA
Hazard: The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
January 17, 2018Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris
Hazard: The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
October 25, 2017Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP
Hazard: The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
August 23, 2017Medical DevicesFDA
CareFusion 303, Inc. recalls VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a
Hazard: Punctures in blister packaging that was detected during the packaging process.
July 19, 2017Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Pump Module model 8100
Hazard: There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.
July 12, 2017Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris PC Unit, Model 8015
Hazard: BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.
May 3, 2017Medical DevicesFDA
CareFusion 303, Inc. recalls SmartSite Add-On Bag Access Device, Model No. 10013365
Hazard: CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion.
March 29, 2017Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the
Hazard: Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.
March 22, 2017Medical DevicesFDA
CareFusion 303, Inc. recalls MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer f
Hazard: CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.
March 22, 2017Medical DevicesFDA
CareFusion 303, Inc. recalls MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
Hazard: CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.
January 25, 2017Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a
Hazard: During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
October 5, 2016Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris Syst
Hazard: A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.
July 6, 2016Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply
Hazard: A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.
May 11, 2016Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for t
Hazard: The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.
March 30, 2016Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
Hazard: CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).
March 23, 2016Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
Hazard: CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.
February 24, 2016Medical DevicesFDA
CareFusion 303, Inc. recalls Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesth
Hazard: Customers reported issues when scanning medications with the scanners. When a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the Pyxis product.