Data / Medical devices / United States / CareFusion 303, INC

CareFusion 303, INC: FDA-registered device maker in San Diego, CA, United States, 6 510(k) clearances

Name: CareFusion 303, INC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

CareFusion 303, INC is registered with the FDA (registration 3003879246) in San Diego, CA, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 25, 2025. 12 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3003879246
Address: 3750 Torrey View Ct, San Diego, CA, United States, 92130
Owner or operator: CareFusion 303, INC. (9068764)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: September 10, 2007
Registered through: 2027
Brand names listed: Alaris PC Unit, Alaris PCA, Alaris/Medley EtCO2 Module, Alaris/Medley SpO2 Module, Alaris Auto-ID Module, Alaris Guardrails Editor Software, Alaris PCA Module, Model 8120, Alaris PCA Module, Model 8120, Software and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Cabinet, Table And Tray, Anesthesia	BRY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Infusion Safety Management Software	PHC	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Oximeter	DQA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Pump, Infusion	FRN	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Pump, Infusion, Pca	MEA	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 25, 2025	K243855	BD Alaris Infusion System with Guardrails Suite MX	FRN	Substantially Equivalent	Carefusion 303, Inc.	accessdata.fda.gov
July 21, 2023	K211218	BD Alaris System with Guardrails Suite MX v12.1.2	FRN	Substantially Equivalent	Carefusion 303, Inc.	accessdata.fda.gov
October 20, 2005	K051641	ALARIS SYSTEM PC UNIT, MODEL 8001	FRN	Substantially Equivalent	Cardinal Health, Alaris Products	accessdata.fda.gov
December 10, 2004	K043299	MEDLEY PCA MODULE, MODEL 8120	MEA	Substantially Equivalent	Alaris Medical Systems, Inc.	accessdata.fda.gov
February 9, 2004	K031741	MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300	CCK	Substantially Equivalent	Alaris Medical Systems, Inc.	accessdata.fda.gov
June 8, 2001	K010966	MEDLEY SP02 MODULE, MODEL 8220	DQA	Substantially Equivalent	Alaris Medical Systems, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 6, 2013	64728	Class I	Terminated	Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.	The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.	accessdata.fda.gov
March 6, 2013	64653	Class II	Terminated	Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System	The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of	accessdata.fda.gov
December 20, 2012	64204	Class II	Terminated	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.	CareFusion is recalling the SmartSite Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing. The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.	accessdata.fda.gov
December 24, 2008	52767	Not yet classified	Terminated	Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA. The Pyxis Anesthesia Station 3500 is a medication dispensing product that provides medication and inventory management for	Cardinal Health has sent out a Safety Alert Notification to inform its customers that the SR2b Software for the Pyxis Anesthesia System 3500 (PAS 3500) has received several customer reports of system "non-responsiveness" (lock ups) during the use of the product since its release in September 2008.	accessdata.fda.gov
March 5, 2008	47335	Not yet classified	Terminated	U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8100 built on or before September 8, 2005. CardinalHealth, San Diego, CA 92130	A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failures of the U19 Socketed Integrated Circuits (U19 IC) on the logic board of the Alaris Pump module ("Pump module"). The user will be required to replace the affected module.	accessdata.fda.gov
October 29, 2007	45504	Not yet classified	Terminated	Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100, Cardinal Health, San Diego, CA. (All Alaris Pump modules shipped prior to December 23, 2007 are subject to this recall)	Inaccurate flow rate; related to misassembled (missing, bent or broken) springs during the manufacturing or servicing of the mechanism assembly	accessdata.fda.gov
August 30, 2007	44826	Not yet classified	Terminated	Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.	Leaks: there is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or on syringes are not affected by this issue)	accessdata.fda.gov
August 13, 2007	39378	Not yet classified	Terminated	Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA	System lock up; mini-drawers -under certain circumstances during use, are not accessable, delaying the user from accessing critical medications.	accessdata.fda.gov
June 18, 2007	38225	Not yet classified	Terminated	All IV Administration Infusion Sets intended for use with the Gemini Infusion Pump and Alaris Pump module (a.k.a. Medley Pump module) including: Alaris SmartSite Low Sorbing Set, Alaris Vented Syringe Adapter Set, Alaris	It has been determined that with low probability, over-infusion may occur as a result of an open safety clamp fitment (a.k.a. Flo-Stop fitment) on the pumping segment, whether opened intentionally in the course of expected clinical practice, or as a result of inadvertent action. The over-infusion occurrence is dependent on the user not closing the roller cla	accessdata.fda.gov
June 5, 2007	38215	Not yet classified	Terminated	Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013	The sterility of the product may be compromised as the packaging used for the sterility barrier was not designed for the sterility process used by the firm.	accessdata.fda.gov
August 10, 2006	36064	Not yet classified	Terminated	Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232	This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce.	accessdata.fda.gov
November 10, 2004	30451	Not yet classified	Terminated	Model 8100 Series Medley Medication Safety System Pump Module	The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from three (3) different customer locations.	accessdata.fda.gov

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Updated April 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.