Data / Medical devices / United States / Baxter Healthcare Corporation

Baxter Healthcare Corporation: FDA-registered device maker in Round Lake, IL, United States, 106 510(k) clearances and 6 PMA approvals

Name: Baxter Healthcare Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Baxter Healthcare Corporation is registered with the FDA (registration 1416980) in Round Lake, IL, United States. It lists 58 device types. The FDA files 106 510(k) clearances and 6 PMA approvals under its listings, the newest dated July 28, 2025. 106 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Baxter Healthcare Corporation

FDA registration number: 1416980
Address: 25212 W. Illinois Route 120, Round Lake, IL, United States, 60073
Owner or operator: BAXTER HEALTHCARE CORPORATION (1417572)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: April 1, 1991
Registered through: 2026
Brand names listed: 3 Lead Ext w/2 Interlink Inject Sit, 3 Port Adapter, 719-3 Li-Ion Plus USB Handle for Desk Charger, 719-DSK Welch Allyn Universal Desk Charger, 719-USB USB POWER SUPPLY,5V,1.4A,USB-A, ADAPTACAP, ALTAPORE, ARS-530 Air Regulator System and more

Devices it lists

Device	Product code	Class	Role	Source
Absorbable Collagen Hemostatic Agent With Thrombin	PMX	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Accessories, Catheter	KGZ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Adaptor, Ureteral Catheter	EYI	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Administrations Sets With Neuraxial Connectors	PWH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Agent, Absorbable Hemostatic, Collagen Based	LMF	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Agent, Absorbable Hemostatic, Non-Collagen Based	LMG	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Applier, Surgical, Clip	GDO	1	Complaint file establishment	accessdata.fda.gov
Arthroscope	HRX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Barrier, Absorbable, Adhesion	MCN	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Block, Heating	JRG	1	Complaint file establishment	accessdata.fda.gov
Bone Grafting Material, Synthetic	LYC	2	Complaint file establishment	accessdata.fda.gov
Clamp, Vascular	DXC	2	Complaint file establishment	accessdata.fda.gov
Clip, Implantable	FZP	2	Complaint file establishment	accessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Complaint file establishment	accessdata.fda.gov
Container, I.V.	KPE	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Device, Anastomotic, Microvascular	MVR	2	Complaint file establishment	accessdata.fda.gov
Dilator, Vessel, Surgical	DWP	2	Complaint file establishment	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Dura Substitute	GXQ	2	Complaint file establishment	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Complaint file establishment	accessdata.fda.gov
Filter, Infusion Line	FPB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Flowmeter, Blood, Cardiovascular	DPW	2	Complaint file establishment	accessdata.fda.gov
Forceps	HTD	1	Complaint file establishment	accessdata.fda.gov
Infusion Safety Management Software	PHC	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Complaint file establishment	accessdata.fda.gov
Intracardiac Patch Or Pledget, Biologically Derived	PSQ	2	Complaint file establishment	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Mesh, Surgical	FTM	2	Complaint file establishment	accessdata.fda.gov
Mesh, Surgical, Collagen, Staple Line Reinforcement	OXE	2	Complaint file establishment	accessdata.fda.gov
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction	OXB	2	Complaint file establishment	accessdata.fda.gov
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	PAJ	2	Complaint file establishment	accessdata.fda.gov
Ophthalmoscope, Battery-Powered	HLJ	2	Complaint file establishment	accessdata.fda.gov
Otoscope	ERA	1	Complaint file establishment	accessdata.fda.gov
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	DXZ	2	Complaint file establishment	accessdata.fda.gov
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	KHJ	2	Complaint file establishment	accessdata.fda.gov
Pump, Infusion	FRN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Pump, Infusion, Elastomeric	MEB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Pump, Infusion, Enteral	LZH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Regulator, Pressure, Gas Cylinder	CAN	1	Complaint file establishment	accessdata.fda.gov
Sealant, Polymerizing	NBE	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Set, Blood Transfusion	BRZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Set, I.V. Fluid Transfer	LHI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stand, Infusion	FOX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Stand, Instrument, Ophthalmic, Battery Powered	NOI	1	Complaint file establishment	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Complaint file establishment	accessdata.fda.gov
Stopcock, I.V. Set	FMG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Syringe, Piston	FMF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment	accessdata.fda.gov
System, Irrigation, Urological	LJH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Processing For Frozen Blood	KSW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Skin Closure	MKY	1	Complaint file establishment	accessdata.fda.gov
System/Device, Pharmacy Compounding	NEP	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment	accessdata.fda.gov
Wax, Bone	MTJ	U	Complaint file establishment	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. Newest 100 of 106.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 28, 2025	K251640	SIGMA Spectrum Infusion Pump with Master Drug Library	FRN	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
July 28, 2025	K251636	Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)	FRN	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
March 14, 2025	K243529	Solution Administration Sets	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
February 28, 2025	K242339	Intravascular Extension Sets and Accessories	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
January 15, 2025	K242541	GEM ZIPCLIP	FZP	Substantially Equivalent	Synovis Micro Companies Alliance A Subsidiary of Baxter Int	accessdata.fda.gov
September 5, 2024	K242390	Novum IQ Syringe Pump (40800BAXUS)	FRN	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
August 2, 2024	K241564	Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS	MQV	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
March 29, 2024	K230665	Dose IQ Safety Software	PHC	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
March 29, 2024	K211122	Novum IQ Large Volume Pump	FRN	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
January 28, 2024	K233394	Gem Flow Now (GEM2770-FN)	IYN	Substantially Equivalent	Synovis Micro Companies Alliance	accessdata.fda.gov
April 7, 2023	K223052	Peri-Guard and Supple Peri-Guard	FTM	Substantially Equivalent	Synovis Life Technologies, Inc.	accessdata.fda.gov
March 10, 2023	K223175	lntravascular Administration Sets with Stopcock and Manifold	FMG	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
November 17, 2022	K220558	Blood Administration Sets	BRZ	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
October 19, 2022	K221032	Vascu-Guard Vascular Repair Patch	PSQ	Substantially Equivalent	Synovis Life Technologies, Inc.	accessdata.fda.gov
October 19, 2022	K221029	PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch	PSQ	Substantially Equivalent	Synovis Life Technologies, Inc.	accessdata.fda.gov
October 3, 2022	K212262	PCA Syringe Sets	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
September 14, 2022	K221843	GEM Biover Microvascular Clamps	DXC	Substantially Equivalent	Synovis Micro Companies Alliance, Inc.	accessdata.fda.gov
November 23, 2021	K211649	PCEA Syringe Set	PWH	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
October 27, 2021	K213125	PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology	FTM	Substantially Equivalent	Synovis Life Technologies. Inc. (A Subsidiary of Baxter	accessdata.fda.gov
September 30, 2021	K203609	Intravascular Administration Sets	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
June 18, 2021	K210430	Intravascular Extension Set	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
June 10, 2021	K210335	Blood Administration Set	BRZ	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
June 30, 2020	K201464	Altapore MIS	MQV	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
May 8, 2020	K200640	ALTAPORE SHAPE	MQV	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
January 9, 2020	K192363	Altapore	MQV	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
January 8, 2020	K193137	EASYGRIP FLO-41 Precision MIS Delivery System	GCJ	Substantially Equivalent	Baxter Healthcare Corportation	accessdata.fda.gov
December 17, 2019	K192615	Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)	FTM	Substantially Equivalent	Synovis Life Technologies, Inc. (Baxter International Inc.)	accessdata.fda.gov
September 6, 2019	K190499	Gem FlowCoupler System	MVR	Substantially Equivalent	Baxter/ Synovis Micro Companies Alliance, Inc.	accessdata.fda.gov
July 9, 2019	K191252	Gem FlowCoupler System	MVR	Substantially Equivalent	Baxter/ Synovis Micro Companies Alliance, Inc.	accessdata.fda.gov
May 28, 2019	K180739	Clearlink System Solution Set	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
August 17, 2018	K181306	Actifuse Flow	MQV	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
May 11, 2018	K173084	Spectrum IQ Infusion System, Dose IQ Safety Software	FRN	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
September 22, 2017	K172544	IV Fat Emulsion Administration Sets	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
November 30, 2016	K161323	Solution Set for Epidural Use	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
December 28, 2015	K153158	Solution Administration Sets with 0.2 Micron Filter	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
April 16, 2015	K150860	Nitroglycerin Sets with DUO-VENT Spike	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
January 16, 2015	K143589	GEM Flow COUPLER Device and System	MVR	Substantially Equivalent	Synovis Life Technologies, Inc.	accessdata.fda.gov
November 19, 2014	K142600	VIAL-MATE Adaptor	LHI	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
September 16, 2014	K142309	GEM Flow COUPLER Device and System	MVR	Substantially Equivalent	Synovis Life Technologies, Inc.	accessdata.fda.gov
August 18, 2014	K142011	SOLUTION SET/EXTENSION SET	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
May 7, 2014	K133801	BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY	FRN	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
October 22, 2013	K132727	GEM FLOW COUPLER DEVICE AND SYSTEM	MVR	Substantially Equivalent	Synovis Life Technologies, Inc.	accessdata.fda.gov
October 8, 2013	K132734	NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
April 24, 2013	K130896	VASCULAR PROBE, VASCULAR PROBE ES	DWP	Substantially Equivalent	Synovis Life Technologies, Inc.	accessdata.fda.gov
March 1, 2013	K130245	LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO	FMG	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
January 10, 2013	K123874	INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
January 8, 2013	K123868	INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
June 29, 2012	K121634	INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
December 8, 2011	K113227	NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER	FPB	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
October 18, 2011	K112893	CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
June 14, 2011	K111217	ADDITIVE CAP	KPE	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
October 8, 2010	K102071	OSTENE CT, AOC CT, OSTEOTENE, CERETENE	MTJ	Substantially Equivalent	Ceremed , Inc.	accessdata.fda.gov
July 2, 2010	K101487	CHEETAH NICOM SYSTEM	DXG	Substantially Equivalent	Cheetah Medical, Inc.	accessdata.fda.gov
February 1, 2010	K093310	GEM FLOW COUPLER DEVICE AND SYSTEM	MVR	Substantially Equivalent	Synovis Micro Companies Alliance, Inc.	accessdata.fda.gov
July 30, 2009	K090850	ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE	LYC	Substantially Equivalent	Apatech , Ltd.	accessdata.fda.gov
June 22, 2009	K091636	OSTENE CT, AOC CT, OSTEOTENE, CERETENE	MTJ	Substantially Equivalent	Ceremed , Inc.	accessdata.fda.gov
November 26, 2008	K083039	VERITAS COLLAGEN MATRIX (DRY)	FTM	Substantially Equivalent	Synovis Surgical Innovations	accessdata.fda.gov
November 25, 2008	K082575	ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES	MQV	Substantially Equivalent	Apatech , Ltd.	accessdata.fda.gov
November 6, 2008	K081979	ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE	MQV	Substantially Equivalent	Apatech , Ltd.	accessdata.fda.gov
September 24, 2008	K082491	OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE	MTJ	Substantially Equivalent	Ceremed , Inc.	accessdata.fda.gov
September 11, 2008	K082073	ACTIFUSE FLOW BONE GRAFT SUBSTITUTE	MQV	Substantially Equivalent	Apatech , Ltd.	accessdata.fda.gov
September 9, 2008	K071783	VERSAPOD (TM) INSTRUMENT TRAYS	KCT	Substantially Equivalent	Containmed, Inc.	accessdata.fda.gov
April 16, 2008	K080736	ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE	MQV	Substantially Equivalent	Apatech , Ltd.	accessdata.fda.gov
May 31, 2007	K071206	ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE	MQV	Substantially Equivalent	Apatech , Ltd.	accessdata.fda.gov
January 24, 2007	K070093	OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE	KHJ	Substantially Equivalent	Ceremed , Inc.	accessdata.fda.gov
December 11, 2006	K062280	OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE	KHJ	Substantially Equivalent	Ceremed , Inc.	accessdata.fda.gov
December 6, 2006	K062915	VERITAS COLLAGEN MATRIX	FTM	Substantially Equivalent	Synovis Surgical Innovations	accessdata.fda.gov
March 29, 2006	K060074	INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
October 11, 2005	K052528	AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE	MTJ	Substantially Equivalent	Ceremed , Inc.	accessdata.fda.gov
May 2, 2005	K050495	EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)	FMF	Substantially Equivalent	Baxter Healthcare Corp., Bioscience	accessdata.fda.gov
March 24, 2005	K050440	AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12	MTJ	Substantially Equivalent	Ceremed , Inc.	accessdata.fda.gov
October 27, 2004	K041669	VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD	FTM	Substantially Equivalent	Synovis Surgical Innovations	accessdata.fda.gov
August 4, 2004	K040082	PORE-SI BONE GRAFT SUBSTITUTE	MQV	Substantially Equivalent	Apatech , Ltd.	accessdata.fda.gov
July 27, 2004	K041363	AOC BONE WAX	MTJ	Substantially Equivalent	Ceremed , Inc.	accessdata.fda.gov
August 12, 2002	K022523	RAPID-FILL TUBESET, MODEL 90005	LHI	Substantially Equivalent	Baxa Corp.	accessdata.fda.gov
June 24, 2002	K020666	DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML	FMF	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
June 7, 2002	K014088	DUPLOREACH	FMF	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
June 28, 2001	K011317	MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM	MEB	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
March 28, 2001	K002705	EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400	LHI	Substantially Equivalent	Baxa Corp.	accessdata.fda.gov
December 20, 2000	K003730	CHEMO-AIDE DISPENSING PIN	LHI	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
July 5, 2000	K981089	TISSOMAT AND SPRAY SET	FMF	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
November 17, 1999	K993120	MODIFIED BLOOD RECIPIENT SET	BRZ	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
November 12, 1998	K983602	CV PERI-GUARD AND VASCU-GUARD	DXZ	Substantially Equivalent	Bio-Vascular, Inc.	accessdata.fda.gov
October 9, 1998	K983162	PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC	FTM	Substantially Equivalent	Bio-Vascular, Inc.	accessdata.fda.gov
August 4, 1998	K981624	FLO-THRU	DXC	Substantially Equivalent	Bio-Vascular, Inc.	accessdata.fda.gov
July 30, 1998	K982282	DURA-GUARD - DURAL REPAIR PATCH	GXQ	Substantially Equivalent	Bio-Vascular, Inc.	accessdata.fda.gov
December 8, 1997	K973510	DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)	FMF	Substantially Equivalent	Immuno-U.S., Inc.	accessdata.fda.gov
March 31, 1997	K964853	INTRAVIA CONTAINER, EMPTY	KPE	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
June 21, 1996	K961225	CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
May 14, 1996	K960787	TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS	LJH	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
July 27, 1995	K952074	SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
August 3, 1993	K925058	BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET	FPA	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
June 18, 1993	K925126	INTERLINK(TM) INJECTION SITE	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
April 21, 1993	K924064	INTERLINK UNIVERSAL VIAL ADAPTER	LHI	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
April 20, 1993	K921899	INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
March 12, 1992	K915390	3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
September 23, 1991	K913627	3 PORT ADAPTER	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
February 7, 1991	K905159	FLO-RESTER(R) VESSEL SIZER	DWP	Substantially Equivalent	Bio-Vascular, Inc.	accessdata.fda.gov
November 7, 1990	K903159	VALVE CONTROLLER FOR MICROMACRO COMPOUNDER	LHI	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.	accessdata.fda.gov
April 18, 1990	K900585	TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP	LHI	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
May 19, 2023	P210036	PerClot® Polysaccharide Hemostatic System	LMG	7	August 7, 2026	accessdata.fda.gov
March 1, 2013	P100030	ARTERX SURGICAL SEALANT	NBE	18	July 10, 2025	accessdata.fda.gov
July 28, 2006	P050011	ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION	MCN	9	August 23, 2024	accessdata.fda.gov
December 12, 2003	P030039	COSEAL SURGICAL SEALANT	NBE	28	December 18, 2025	accessdata.fda.gov
December 8, 1999	P990009	FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT	PMX	74	November 13, 2025	accessdata.fda.gov
August 12, 1996	P950034	SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE	MCN	52	December 19, 2024	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 106.

Initiated	Event	Class	Status	Product	Reason	Source
June 30, 2021	88219	Class II	Terminated	Sharesource Connectivity Platform for Use with the Amia Automated PD System	Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the	accessdata.fda.gov
September 3, 2014	69122	Class II	Terminated	SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.	One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.	accessdata.fda.gov
October 16, 2013	66737	Class II	Terminated	The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of	The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2) blade may separate from the back plate and cause Slow / No Flow alarm requiring therapy termination.	accessdata.fda.gov
June 7, 2013	65365	Class II	Terminated	Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications.	Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains	accessdata.fda.gov
June 7, 2013	65364	Class II	Terminated	Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposab	Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.	accessdata.fda.gov
December 14, 2012	63898	Class II	Terminated	Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a p	Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.	accessdata.fda.gov
September 7, 2012	63059	Class I	Terminated	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into	Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.	accessdata.fda.gov
July 13, 2012	62558	Class I	Terminated	AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admix	After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experi	accessdata.fda.gov
December 6, 2011	60608	Not yet classified	Terminated	Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 3-Way Stopcock Manifold, Extension Set, 44" (112 cm), Vol. 6.6 mL, Injection Site, Male Luer Lock Ad	During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.	accessdata.fda.gov
August 26, 2011	60168	Not yet classified	Terminated	Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8064. The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intrave	The Flo-Gard infusion Pump was released to the customer with OOS values for the Air Sensor Calibrations with the Air in Tubing test.	accessdata.fda.gov
August 15, 2011	59734	Not yet classified	Terminated	LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in managem	There is the potential for an order entry error during use of the LOGIX Order Entry (OE) software. When adding ingredients to a TPN order, the user can accept the pre-populated "per units" of "Bag" or select other "per units". A dosing error may occur if the user does not select the prescribed "per units" for the added ingredient.	accessdata.fda.gov
July 22, 2011	59449	Not yet classified	Terminated	Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. Product Usage: Intended for use in a wi	Baxter's Service Center tested and returned to the user the Colleague infusion pump that did not meet PSIG (Pounds-force per Square Inch) specifications	accessdata.fda.gov
July 22, 2011	59448	Not yet classified	Terminated	Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Deerfield, IL. Product Code: 2M8161. Intended for use in a wide variety of patient environments for adult, pediat	The Colleague infusion pump may not have met certain Air in Line (AIL) specifications after testing by the Baxter Global Technical Service Center. This issue could potentially cause a delay in initiation of therapy.	accessdata.fda.gov
July 22, 2011	59445	Not yet classified	Terminated	Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Deerfield, IL; product code 2M8161	A review of Baxter service records indicates that the Baxter Colleague CX Infusion Pump has not met certain voltage specifications. This issue could potentially cause a delay in initiation of therapy.	accessdata.fda.gov
July 21, 2011	59419	Not yet classified	Terminated	Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare Corporation. A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvented and flexible contai	The Solution Sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.	accessdata.fda.gov
July 6, 2011	59263	Not yet classified	Terminated	Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per case; Baxter Healthcare	Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.	accessdata.fda.gov
July 5, 2011	59270	Not yet classified	Terminated	Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient	While replacing a defective pump head mechanism and performing calibration, Baxter's Service center may have failed to apply GLYPTOL (a red insulating varnish) on a potentiometer that helps maintain pump accuracy for detecting an air bolus.	accessdata.fda.gov
May 31, 2011	58913	Not yet classified	Terminated	Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use, nonpyrogenic fluid pathway for use with 6200 and 6300 series Flo-Gard Volumetric Infusion Pumps; Baxter Healthcare corpor	The lot of Baxter Solution Set for Epidural Use is being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than fro	accessdata.fda.gov
May 17, 2011	58834	Not yet classified	Terminated	Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site, Rotating Male Luer Lock; a sterile, nonpyrogenic fluid pathway; product code 2N5601. Intended use: For the administration of drugs and so	There is the potential for pinholes and tears in the individual packaging of the stopcocks, compromising the sterility of the product.	accessdata.fda.gov
May 4, 2011	58806	Not yet classified	Terminated	Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2 M8153 and 2M8163. Intended for use in a wide variety of	The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.	accessdata.fda.gov
April 14, 2011	58586	Not yet classified	Terminated	Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161 and 2M9161. Intended f	The Hi-Pot safety testing may not have been conducted on the affected pumps during service, prior to being returned to the end user.	accessdata.fda.gov
March 29, 2011	58420	Not yet classified	Terminated	LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in managem	The LOGIX OE automated backup does not retain the three most recent backup files and instead will only retain the last three backups of the previous year. The software stores backup files in numeric order rather than chronological date order.	accessdata.fda.gov
March 24, 2011	58482	Not yet classified	Terminated	Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063 The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intra	Pumps submitted for service may not have been properly serviced before being returned to the customer.	accessdata.fda.gov
March 15, 2011	58181	Not yet classified	Terminated	Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; Baxter Healthcare Corporation, Deerfield, IL 60015; REF 2C1071KJP The Infusor device is indicated for	Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054.	accessdata.fda.gov
March 4, 2011	62881	Class III	Terminated	Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume	Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not operate. The reason being that the Mini-Infuser Battery Spring has a flat contact that measures.53 inches.01 inches on the inner diameter of the spring coil. The IEC 60086-2 an	accessdata.fda.gov
January 27, 2011	57790	Not yet classified	Terminated	AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 The Automix Compounder Systems are electromechanical p	The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when entering order numbers to download from host software (MAN ID Mode). It is possible that an incorrect volume and/or an incorrect solution could be admixed into t	accessdata.fda.gov
January 10, 2011	57666	Not yet classified	Terminated	InfusO.R. Infusion Pump, an Rx syringe infusion pump; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; product codes 2L3100, 2L3100R, 2L3100U, 6461500 and 6461500R. These product codes includes refurbished unit	Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the InfusOR will not operate. The reason being that the InfusOR (2L3100) Battery Spring has a flat contact that measures.53 inches.01 inches on the inner diameter of the spring coil. The IEC 60086-2 and	accessdata.fda.gov
December 1, 2010	57516	Not yet classified	Terminated	Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8161 and 2M9161. Intended for use in a wide variety of p	The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.	accessdata.fda.gov
December 1, 2010	57515	Not yet classified	Terminated	Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161	While the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection.	accessdata.fda.gov
November 17, 2010	57334	Not yet classified	Terminated	Baxter FloGard 6201 Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product code 2M8063 For delivery of intravenous solutions, drug solutions, enteral feedings and blood.	The FloGard Infusion Pump was released from service without having the Current Leakage test performed. This could lead to the patient/user to receive an electrical shock.	accessdata.fda.gov
October 28, 2010	57089	Not yet classified	Terminated	Baxter Three-Way Large Bore Stopcock with Rotating Male Luer Lock Adapter; a sterile, nonpyrogenic fluid pathway; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 2C6201. Intended use: For the administrat	Rotating the handle on the 3-Way Large Bore Stopcock past the stop can cause the stopcock to leak. A leak can lead to under-infusion or interruption of critical life-sustaining therapy.	accessdata.fda.gov
October 21, 2010	56892	Not yet classified	Terminated	Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3 injection sites, volume per injection site 0.1 mL, priming volume 0.8 mL, length 8.7 cm. Product code 2N3410 and A2N34	If the manifolds are connected in series, there may be a risk of the manifolds loosening or disconnecting at the luer connection between them.	accessdata.fda.gov
September 17, 2010	56792	Not yet classified	Terminated	Baxter V-Link Luer Activated Device with Vitalshield Protective Coating Non-DEHP Catheter Extension Set Kit; 7.6" (19.3 cm), Vol. 1.0 mL, 1 Catheter Extension Set with Luer Activated Device with Silver for IV Access and	The removable paper liner covering the adhesive strip that is used to secure the catheter stabilization device to the patient is pyrogenic. The device is labeled as nonpyrogenic.	accessdata.fda.gov
September 9, 2010	56718	Not yet classified	Terminated	Baxter Clearlink System Non-DEHP Y-Type Catheter Extension Set, 6.5" (16.5 cm), Vol 1.2 mL, Luer Activated Valve for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile device; Manufactured by an a	During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch.	accessdata.fda.gov
September 3, 2010	56699	Not yet classified	Terminated	Baxter Interlink System Buretrol Solution Set, 83" (2.1 m), 150 mL Burette Drip Chamber Filter Valve, 2 Injection Sites, Male Luer Lock Adapter, Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set, 38" (	There are leaks in the Drip Chamber Check Valve Subassembly of the Solution Set. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection.	accessdata.fda.gov
August 4, 2010	56425	Not yet classified	Terminated	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.	The FDA sent a letter to Baxter on April 30, 2010, ordering the company to recall and destroy all models of its Colleague Volumetric Infusion Pumps currently in use in the United States. FDA determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague pumps still in use	accessdata.fda.gov
July 14, 2010	60520	Not yet classified	Terminated	Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. Product Usage: Intended for use in a wi	Baxter's Service Center did not perform the ground impedance and leakage current test which verify if any power overflow occurs and that it is properly discharged through the device electrical system.	accessdata.fda.gov
February 15, 2010	55016	Not yet classified	Terminated	Baxter RenAmin (Amino Acid) Injection; Pharmacy Bulk Package Not for Direct Infusion, Rx Only, 250 mL type II glass bottles; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, Made in USA	Routine stability testing of the evacuated container product, along with trending of results, indicates that the pH will exceed the upper specification limit prior to the expiration date of this product. Baxter decided to remove all potentially affected products even though there have been no out-of-specification pH results at the 0, 6 and 12 month intervals	accessdata.fda.gov
November 3, 2009	53751	Not yet classified	Terminated	Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Retractable Collar;	The tubing may separate from the distal Clearlink Y-site of the set, which could result in patient injury if the separation occurs during patient use.	accessdata.fda.gov
July 2, 2009	52560	Not yet classified	Terminated	Baxter Minicap Extended Life PD Transfer Set (6") with Twist Clamp; six sets per carton; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 5C4482 The set is used in disconnect applications and cycler a	The peritoneal dialysis transfer set has a defective white sleeve twist clamp. The twist clamp will not open or close completely, which could cause leakage and lead to peritonitis.	accessdata.fda.gov
May 8, 2009	60521	Not yet classified	Terminated	Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.	There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.	accessdata.fda.gov
January 23, 2009	50839	Not yet classified	Terminated	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore. Product Codes: 2M8151, 2M8161, 2M9161, DNM8151, DNM91	Baxter has identified failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps.	accessdata.fda.gov
September 5, 2008	49443	Not yet classified	Terminated	Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A. Indicated for infusion via intravenous, intra-arterial, epidural or sub	Non-conforming Electrostatic Discharge (ESD) grounding squares may cause the pump to be susceptible to shorting-out of circuitry, resulting in a loss of audio, and/or interruption of therapy.	accessdata.fda.gov
March 28, 2008	47441	Not yet classified	Terminated	Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number o	Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly.	accessdata.fda.gov
February 28, 2008	46912	Not yet classified	Terminated	Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL vial, 25 Pack, NDC 0641-0392-25 (NDC 0641-0392-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015	Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which used the same active pharmaceutical ingredient (API) source as the HEP LOCK products	accessdata.fda.gov
November 29, 2007	45919	Not yet classified	Terminated	Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case; Baxter Healthcare Corporation, Deerfield, IL 60015	Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.	accessdata.fda.gov
August 15, 2007	39415	Not yet classified	Terminated	Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product code 2M8161	Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.	accessdata.fda.gov
June 21, 2007	38221	Not yet classified	Terminated	Baxter Flo-Gard 6201, SIngle Channel, Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063	Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.	accessdata.fda.gov
June 20, 2007	38219	Not yet classified	Terminated	Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8163, 2M9163	A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels simultaneously infusing fluids. In reported cases, the pump stopped infusing and both an audible and a visual alarm notification were activate	accessdata.fda.gov
February 16, 2007	37362	Not yet classified	Terminated	Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP 12 inch pump segment, 0.22 micron downstream high pressure filter, Luer activated valve, male Luer lock adap	Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.	accessdata.fda.gov
December 6, 2006	36928	Not yet classified	Terminated	Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R	Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user.	accessdata.fda.gov
November 27, 2006	36872	Not yet classified	Terminated	Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015	There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter.	accessdata.fda.gov
February 8, 2006	34579	Not yet classified	Terminated	Baxter Auto Syringe AS40 and AS40A Infusion Pump, product code 1M8565 (pumps with drug library option) and product codes 1M8560 and 1M8560R (pumps without drug library option); Baxter Healthcare Corporation, Medication D	The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.	accessdata.fda.gov
February 7, 2006	34580	Not yet classified	Terminated	Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.	A non-conforming gasket was used in manufacturing of the specific pumps, causing the pumps to be more susceptible to electro-static discharge, which could increase the potential for the pump to fail during use and alarm.	accessdata.fda.gov
January 10, 2006	34381	Not yet classified	Terminated	Baxter Continuous Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing an epidural needle, epidural catheter, glass LOR syringe and non-latex components for the preparat	The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.	accessdata.fda.gov
December 21, 2005	34244	Not yet classified	Terminated	Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015	Delivery of unrequested PCA doses of medication due to damaged PCA cords, partial sticking of PCA button, and fluid ingress into the pump or PCA button.	accessdata.fda.gov
December 15, 2005	34290	Not yet classified	Terminated	Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N8371; An Rx sterile, nonpyrogenic fluid pathway, 6.0'', 1.0 mL Vol., with 2 Luer Activated Valves and a male Luer Lock adapter; Baxter Health	The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.	accessdata.fda.gov
December 13, 2005	34096	Not yet classified	Terminated	Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, BRM8151(Brazilian Port	Interruption of therapy due to battery undercharging, the generation of air-in-line alarms due to IV administration set tugging, and gearbox wear; and underinfusion due to misalignment of the pump head components.	accessdata.fda.gov
November 14, 2005	34020	Not yet classified	Terminated	Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured by an affiliate of B	Failures within the PCA profile as well as incidents resulting in interruptions of therapy in various profiles.	accessdata.fda.gov
November 7, 2005	33999	Not yet classified	Terminated	Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured by an affiliate of B	Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the Power-On Self Test.	accessdata.fda.gov
October 27, 2005	33916	Not yet classified	Terminated	Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015	When infusing at flow rates below 0.5 mL/hr, the upstream occlusion alarm of the pumps may not detect the occlusion.	accessdata.fda.gov
August 29, 2005	33250	Not yet classified	Terminated	Baxter''s Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and Point of Care - product code 2M5014; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, mad	If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached to a medication in the drug file, a Point of Care end user will be unable to enter monitoring parameter results on the handheld.	accessdata.fda.gov
August 17, 2005	33032	Not yet classified	Terminated	Epidural Infusion Pumps sold under the following labels; a) Baxter 6060E Epidural Infusion Pump, product code 2L9351, 2L9351P and 2L9351R; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA,	Potential overinfusion in the Auto-Ramp mode with software versions 3.00 or higher	accessdata.fda.gov
August 3, 2005	32812	Not yet classified	Terminated	Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N3371; An Rx sterile, nonpyrogenic fluid pathway, 5.7'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare C	The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.	accessdata.fda.gov
July 20, 2005	32678	Not yet classified	Terminated	Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R	A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes.	accessdata.fda.gov
July 6, 2005	32589	Not yet classified	Terminated	Baxter Healthcare Corporation, Medication Delivery Division, Syndeo PCA Syringe Pump, product codes 2L3113 and 2L3113R	During an infusion in the 'Basal + PCA' or 'PCA only' modes, the SYNDEO pump may generate false Service Code 919 or Service Code 920, which will cause the pump to stop the infusion. Also, while attempting to turn on the device by pressing the On/Off key, the pump may not power up properly.	accessdata.fda.gov
July 6, 2005	32588	Not yet classified	Terminated	Baxter Interlink System Minivolume Extension Set, product code 1C8290; 11'', 0.86 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.	Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.	accessdata.fda.gov
June 16, 2005	32449	Not yet classified	Terminated	Baxter''s Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and Management Reports - product code 2M5015; Baxter Healthcare Corpor	If a pharmacy end user alters the Administration Unit of Measure (AUOM) of an ordered drug, the AUOM will display incorrectly on the Medication Administration Record for the patient, possibly leading to medication errors.	accessdata.fda.gov
June 13, 2005	32254	Not yet classified	Terminated	Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832, 606000-40, 606000-40L, 606000-40I; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore	There is an overinfusion condition in the Intermittent mode where the pump may continue to deliver at the higher dose rate instead of switching to the lower keep open rate once the first dose is completed.	accessdata.fda.gov
May 31, 2005	32191	Not yet classified	Terminated	Baxter Interlink System Huber Needle Extension Set; a sterile 10'' fluid pathway with an Interlink Y-Injection Site and 3/4'' x 22 gauge needle; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.;	Some of the product code 2N3709 extension sets with Y-injections sites were placed in packages labeled as product code 2N3703 extension sets which do not have Y-injection sites.	accessdata.fda.gov
May 6, 2005	31992	Not yet classified	Terminated	Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.	A 'Check Flange' alarm may occur even though the syringe has been properly loaded into the AS50 Infusion Pump. The false alarm may occur during the syringe loading process or while an infusion is running. Also, the occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.	accessdata.fda.gov
May 4, 2005	31969	Not yet classified	Terminated	Baxter Sabraset 6060 Administration Set with Pre-attached 250 mL Bag and Cassette, product code 560500-250; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Mexico	The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.	accessdata.fda.gov
May 3, 2005	31965	Not yet classified	Terminated	Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished), 2M8063G (global), 2M8063U, 2M8063F, 2M8063A, 2M8063D & 2M8063B; Baxter Healthcare Corporation, Deerfield, IL 60015	The mounting screws of the pole clamp may come loose, allowing the pole clamp assembly to detach from the rear pump housing, if they are not maintained on at least an annual basis.	accessdata.fda.gov
April 21, 2005	31800	Not yet classified	Terminated	Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid pathway for administration of IV fluids; Manufactured by an	There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set.	accessdata.fda.gov
March 28, 2005	31491	Not yet classified	Terminated	Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25G x 8.9 cm (3-1/2'') Whitacre Spinal Needles; Assembled by Baxter Healthcare Corporation, Deerfield, IL 60015	The anesthesia trays contain BD 25G Spinal Needles which which have leakage at the plastic hub of the needle.	accessdata.fda.gov
March 17, 2005	31469	Not yet classified	Terminated	Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball Valve, 2 injection sites and male luer lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A	The Buretrol solution sets are currently labeled as acceptable for use with the Colleague Volumertric Pump, but there is a potential for a non-detection of an upstream occlusion under certain conditions.	accessdata.fda.gov
March 15, 2005	31490	Not yet classified	Terminated	Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R	The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11.	accessdata.fda.gov
March 10, 2005	31467	Not yet classified	Terminated	Clinician Workstation Software, product code 2M5042	The medication administration results displayed in the 'View Results' link may be inaccurate.	accessdata.fda.gov
March 3, 2005	31275	Not yet classified	Terminated	Baxter PosiFlow Access Device for IV Access; product code 2N9050; a single use, sterile device with PosiFlow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL; Baxter Healthcare Corp., Deerfield, IL 60015	Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.	accessdata.fda.gov
March 2, 2005	31266	Not yet classified	Terminated	Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155; Baxter Healthcare Corporation, Deerfield, IL	The Configuration Tranfer Cable for the Colleague Infusion Pumps has incorrect thumb screws on it., not allowing firm connections of the cable to the pump to transfer data to the biomedical engineer's diagnostic device.	accessdata.fda.gov
February 28, 2005	31245	Not yet classified	Terminated	Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe; Baxter	Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.	accessdata.fda.gov
February 25, 2005	31188	Not yet classified	Terminated	Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8151, 2M8151R, 2M8161, 2M8161R	Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of time after teh Battery Depleted alarm occurs.	accessdata.fda.gov
February 10, 2005	31191	Not yet classified	Terminated	Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015	Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump.	accessdata.fda.gov
January 20, 2005	31019	Not yet classified	Terminated	Baxter Posiflow Access Device for IV Access; product code 2N9050; a single use, sterile device with Posiflow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL; Baxter Healthcare Corp., Deerfield, IL 60015	Product older than three years may not operate as intended.	accessdata.fda.gov
December 20, 2004	30715	Not yet classified	Terminated	Anesthesia Set, product code 2C9216; a sterile fluid path consisting of a 72'' long PVC with DEHP tubing with a green stripe, inner diameter of 0.040'', priming volume 1.7 mL, with a luerlock connector with fixed collar;	The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component.	accessdata.fda.gov
December 20, 2004	30714	Not yet classified	Terminated	Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073	Logix-CM software version 3.0.4 has not completed its official release process.	accessdata.fda.gov
December 8, 2004	30609	Not yet classified	Terminated	Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073	A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in Logix and another order entry program being used with the Logix software.	accessdata.fda.gov
November 19, 2004	30506	Not yet classified	Terminated	Baxter labeled 6060 Solution Sets with AutoClamp; For use with model 6060 multi-therapy pumps only; a prescription, sterile, non-pyrogenic fluid pathway; Manufactured by an affiliate of Baxter Healthcare Corporation, Dee	A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient.	accessdata.fda.gov
November 4, 2004	30381	Not yet classified	Terminated	Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151and 2M8151R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display screen	A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.	accessdata.fda.gov
September 1, 2004	29958	Not yet classified	Terminated	Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product code 2L9354 and previously marketed by Sabratek under product code 606194, Baxter Healthcare Corporation, Deerfield, IL 60015	The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm 'Door Open', but if the pump is turned off to silence the alarm while remaining in the lock box, the fluid will free-flow.	accessdata.fda.gov
April 30, 2004	29017	Not yet classified	Terminated	Compounding Brochure titled ''Nutrition Compounding Simplified'', Lit #800415, print date January 2002; the brochure is applicable to the Automix Plus High Speed Compounder System, product 2M8075, the Automix High Speed	The promotional material for the Automix/Accusource and Micromix compounders and Micromix Compounder Implementation Guide contain an incomplete accuracy statement regarding the delivery of each ingredient by the compounders.	accessdata.fda.gov
April 28, 2004	29014	Not yet classified	Terminated	Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, extension sets and blood sets that have a luer activated valve for IV access, which allows the administration of medications/soluti	Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device.	accessdata.fda.gov
April 26, 2004	28921	Not yet classified	Terminated	Clintec Micromix Compounder, an I.V. solution compounder; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA; product code 2M8290 - 1.0 mL accuracy, and product code 2M8290L - less than 1.	The Micromix compounder may have ingredient delivery outside of the stated accuracy limits if the Vlier pin is not properly adjusted	accessdata.fda.gov
April 13, 2004	28824	Not yet classified	Terminated	Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151and 2M8151K (United Kingdom); Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display screen	Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.	accessdata.fda.gov
December 17, 2003	28037	Not yet classified	Terminated	Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore	Premature motor failure.	accessdata.fda.gov
December 16, 2003	28038	Not yet classified	Terminated	Micromix BCR Compounder, product code 2M8297; a pharmacy automation device with a barcode reader used in preparation of parenteral solutions; Baxter Healthcare Corporation, Clintec Nutriiton Division, Deerfield, IL 60015	The compounder may omit an ingredient during the compounding process.	accessdata.fda.gov
December 5, 2003	27896	Not yet classified	Terminated	Baxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q (English) and N5C4479Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 30 units per case	Reports of loosening of the connections and disconnection of the device.	accessdata.fda.gov
October 30, 2003	27605	Not yet classified	Terminated	CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Japan; 24 units per case	Use of the dialyzers may cause iritis (red-eye) patient reactions.	accessdata.fda.gov
July 16, 2003	26772	Not yet classified	Terminated	Continu-Flo Solution Set, 10 drops/mL, 113'', 2 Luer Activated Valves, Male Luer Lock Adapter, catalog 2C9907; Baxter Healthcare Corporation, Deerfield, IL 60015 USA	There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.	accessdata.fda.gov
March 20, 2003	25818	Not yet classified	Terminated	Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield,	The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.	accessdata.fda.gov

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Updated August 7, 2026. 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.