Data / Medical devices / United States / Icu Medical, Inc.

Icu Medical, Inc.: FDA-registered device maker in San Clemente, CA, United States, 211 510(k) clearances

Name: Icu Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Icu Medical, Inc. is registered with the FDA (registration 2025816) in San Clemente, CA, United States. It lists 92 device types. The FDA files 211 510(k) clearances under its listings, the newest dated June 5, 2025. 45 recall events name it as the recalling firm (4 Class I). Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Icu Medical, Inc.

FDA registration number: 2025816
Address: 951 Calle Amanecer, San Clemente, CA, United States, 92673
Owner or operator: ICU MEDICAL, INC. (2025816)
Roles: Complaint file establishment, Specification developer
First device listed: August 4, 1999
Registered through: 2026
Brand names listed: ADAPTOR, CATHETER, AIRWAY, NASOPHARYNGEAL, AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY, ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE, APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED, Absorbent, carbon-dioxide, Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass, Additive Hinge Cap and more

Devices it lists

Device	Product code	Class	Role	Source
Absorbent, Carbon-Dioxide	CBL	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Adaptor, Catheter	GCE	1	Specification developer	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Administrations Sets With Neuraxial Connectors	PWH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Airway, Nasopharyngeal	BTQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Airway, Oropharyngeal, Anesthesiology	CAE	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Anesthesia Conduction Kit	CAZ	2	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
Arterial Blood Sampling Kit	CBT	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Attachment, Breathing, Positive End Expiratory Pressure	BYE	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Bag, Reservoir	BTC	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Bed, Rocking, Breathing Assist	CCO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Specification developer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Cap, Device Disinfectant	QBP	2	Specification developer	accessdata.fda.gov
Cardiograph, Apex (Vibrocardiograph)	DQH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Cholangiography	GBZ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Conduction, Anesthetic	BSO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Flow Directed	DYG	2	Specification developer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Oximeter, Fiber-Optic	DQE	2	Specification developer	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	ONB	2	Specification developer	accessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)	BYD	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Container, I.V.	KPE	2	Specification developer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Cuff, Tracheal Tube, Inflatable	BSK	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Device, Fixation, Tracheal Tube	CBH	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Filter, Conduction, Anesthetic	BSN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Filter, Infusion Line	FPB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Gauge, Measuring	JYJ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Hemodialysis Catheter Luer End Cap	PEH	2	Specification developer	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Mask, Oxygen, Low Concentration, Venturi	BYF	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Mask, Oxygen, Non-Rebreathing	KGB	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Meter, Airway Pressure (Inspiratory Force)	BXR	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass	DTW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	CAP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Needle, Emergency Airway	BWC	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Needle, Spinal, Short Term	MIA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Oximeter	DQA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Percussor, Powered-Electric	BYI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Port & Catheter, Implanted, Subcutaneous, Intravascular	LJT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Probe, Blood-Flow, Extravascular	DPT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Probe, Thermodilution	KRB	2	Specification developer	accessdata.fda.gov
Regulator, Pressure, Gas Cylinder	CAN	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Resuscitator, Manual, Non Self-Inflating	NHK	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Set, I.V. Fluid Transfer	LHI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Specification developer	accessdata.fda.gov
Spirometer, Therapeutic (Incentive)	BWF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Splint, Extremity, Noninflatable, External, Sterile	FYH	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Stethoscope, Esophageal	BZW	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Stethoscope, Esophageal, With Electrical Conductors	BZT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stopcock, I.V. Set	FMG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stylet, Tracheal Tube	BSR	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Support, Breathing Tube	JAY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Syringe, Piston	FMF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Thermal Regulating	DWJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System/Device, Pharmacy Compounding	NEP	2	Specification developer	accessdata.fda.gov
Transducer, Blood-Pressure, Extravascular	DRS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Tube Tracheostomy And Tube Cuff	JOH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	CBI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)	BTO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Valve, Non-Rebreathing	CBP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)	BTM	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)	BTL	2	Complaint file establishment, 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. Newest 100 of 211.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 5, 2025	K250616	Clave Neutral-Displacement Needlefree Connectors	FPA	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
January 22, 2025	K243985	Rio Drug Reconstitution Transfer Device	LHI	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
November 26, 2021	K210833	Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula	JOH	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
August 26, 2021	K211634	Hypodermic Needle-Pro EDGE Safety Device	FMI	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
April 20, 2020	K192154	Rio Vial-to-Bag Drug Reconstitution Device	LHI	Substantially Equivalent	Icu Medical	accessdata.fda.gov
March 6, 2020	K190918	SwabTip Male Disinfectant Cap	QBP	Substantially Equivalent	Icu Medical	accessdata.fda.gov
October 24, 2019	K181660	Acapella Choice Blue Vibratory PEP Device	BWF	Substantially Equivalent	Smiths Medical	accessdata.fda.gov
July 25, 2019	K183066	The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model	DYB	Substantially Equivalent	Access Scientific, LLC	accessdata.fda.gov
August 31, 2018	K173477	ChemoCLAVE Cytotoxic Medication Preparation and Delivery System	ONB	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
July 26, 2018	K181699	Level 1 Convective Warmer	DWJ	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
June 14, 2018	K172800	Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors	MIA	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
June 12, 2018	K172823	Portex NRFit Epidural Needles	BSP	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
June 1, 2018	K172410	Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters	BSP	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
May 25, 2018	K180111	ClearGuard HD Antimicrobial Barrier Cap	PEH	Substantially Equivalent	Pursuit Vascular, Inc.	accessdata.fda.gov
May 8, 2018	K173912	BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube	JOH	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
April 10, 2018	K173384	BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube	BTO	Substantially Equivalent	Smiths Medical Ads, Inc.	accessdata.fda.gov
January 25, 2018	K171968	EchoGlo Needle	BSP	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
December 7, 2017	K170720	Portex Blue Line Ultra Paediatric Tracheosomy Tube	JOH	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
November 9, 2017	K172458	HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit	DRS	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
July 20, 2017	K162219	CADD® Infusion Disposables Portfolio with NRFit connectors	PWH	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
May 24, 2017	K163172	HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit	DRS	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
June 30, 2016	K160235	ViaValve Safety I.V. Catheter	FOZ	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
May 5, 2016	K152006	Cogent Hemodynamic Monitoring System	DXQ	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
March 11, 2016	K160374	20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System	FOZ	Substantially Equivalent	Tangent Medical Technologies, Inc.	accessdata.fda.gov
July 2, 2014	K140129	PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER	DQE	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
September 16, 2013	K123957	PNEUPAC PARAPAC PLUS	BTL	Substantially Equivalent	Smiths Medical International , Ltd.	accessdata.fda.gov
August 2, 2012	K121525	PERIFUSE CATHETER	CAZ	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
July 20, 2012	K120839	NOVACATH SECURE IV CATHETER SYSTEM-18G	FOZ	Substantially Equivalent	Tangent Medical Technologies, Inc.	accessdata.fda.gov
March 14, 2012	K113700	VIAVALVE SAFETY IV CATHETER	FOZ	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
February 9, 2012	K112407	SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS	DYB	Substantially Equivalent	Smiths Medical MD, Inc.	accessdata.fda.gov
August 3, 2010	K101180	GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,	FPA	Substantially Equivalent	Smiths Medical MD, Inc.	accessdata.fda.gov
March 1, 2010	K093414	PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS	LJT	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
November 4, 2009	K092657	EPIFUSE CATHETER CONNECTOR, MODEL: 4909E	CAZ	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
August 18, 2009	K083031	PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT	BTO	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
June 3, 2009	K083336	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	DWJ	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
May 1, 2009	K090261	PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G	BSP	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
May 1, 2009	K083557	BCI WW1030 PULSE OXIMETER	DQA	Substantially Equivalent	Smiths Medical Pm, Inc.	accessdata.fda.gov
April 28, 2009	K090205	BCI WW1021 PC APPLICATION	DQA	Substantially Equivalent	Smiths Medical Pm, Inc.	accessdata.fda.gov
April 15, 2009	K083787	BCI WW1000 PULSE OXIMETER, MODEL WW1000	DQA	Substantially Equivalent	Smiths Medical Pm, Inc.	accessdata.fda.gov
April 9, 2009	K083705	BCI WW1020 PULSE OXIMETER, MODEL WW1020	DQA	Substantially Equivalent	Smiths Medical Pm, Inc.	accessdata.fda.gov
March 4, 2009	K083451	PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS	BSN	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
February 25, 2009	K082836	ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES	FMG	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
February 23, 2009	K083641	BIVONA TRACHEOSTOMY TUBES	JOH	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
September 12, 2008	K081440	BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES	JOH	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
August 28, 2008	K081361	CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX	FPA	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
August 13, 2008	K081086	PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0	BTR	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
July 21, 2008	K081229	SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING	JKA	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
May 2, 2008	K080989	UNIVERSAL VIAL ACCESS SPIKE	FMF	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
December 14, 2007	K072657	POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS	LJT	Substantially Equivalent	Smiths Medical MD, Inc.	accessdata.fda.gov
October 4, 2007	K071527	PNEUPAC VR1 AIR MIX	BTL	Substantially Equivalent	Smiths Medical International , Ltd.	accessdata.fda.gov
August 2, 2007	K071785	HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE	FMI	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
August 1, 2007	K071269	HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM	CBT	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
July 9, 2007	K070732	BCI AUTOCON 3304 DIGITAL PULSE OXIMETER	DQA	Substantially Equivalent	Smiths Medical Pm, Inc.	accessdata.fda.gov
June 5, 2007	K070633	GENIE, MODEL CH-200	FMF	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
March 15, 2007	K070340	SECURE ARTERIAL BLOOD SAMPLING SYSTEM	CBT	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
February 27, 2007	K063755	PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE	MEG	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
October 18, 2006	K062005	PORTEX EPIDURAL CATHETER	BSO	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
August 24, 2006	K061194	PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558	MEG	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
August 4, 2006	K061450	HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS	DQE	Substantially Equivalent	Hospira, Inc.	accessdata.fda.gov
June 19, 2006	K060945	PORTEX PERCUTANEOUS TRACHEOSTOMY KIT	BTO	Substantially Equivalent	Smiths Medical International	accessdata.fda.gov
January 10, 2006	K053106	TEGO, MODEL D1000	FPA	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
December 22, 2005	K052865	HOSPIRA CATH LAB CONVENIENCE KITS	DQO	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
August 5, 2005	K051322	PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS	BTL	Substantially Equivalent	Smiths Medical International , Ltd.	accessdata.fda.gov
July 7, 2005	K051524	LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216	BSO	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
May 26, 2005	K050166	PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT	BWC	Substantially Equivalent	Smiths Medical	accessdata.fda.gov
April 22, 2005	K043495	BABYPAC	BTL	Substantially Equivalent	Smiths Medical International Ltd., Luton	accessdata.fda.gov
February 18, 2005	K042683	WELL LEAD ENDOTRACHEAL TUBE	BTR	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
October 7, 2004	K042172	CLEO 90 INFUSION SET	FPA	Substantially Equivalent	Smiths Medical MD, Inc.	accessdata.fda.gov
September 1, 2004	K042182	Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432	FPA	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
July 28, 2004	K041399	HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE	FMI	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
July 13, 2004	K041348	PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA	JOH	Substantially Equivalent	Smiths Medical	accessdata.fda.gov
May 13, 2004	K033008	AIR SAFETY HEPA AND NON-HEPA FILTERS	CAH	Substantially Equivalent	Air Safety, Ltd.	accessdata.fda.gov
February 13, 2004	K040014	PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY	JOH	Substantially Equivalent	Portex , Ltd.	accessdata.fda.gov
January 26, 2004	K032112	P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)	BTR	Substantially Equivalent	Portex , Ltd.	accessdata.fda.gov
November 28, 2003	K032716	PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)	CAH	Substantially Equivalent	Portex , Ltd.	accessdata.fda.gov
September 17, 2003	K030570	BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE	BTO	Substantially Equivalent	Portex , Ltd.	accessdata.fda.gov
August 27, 2003	K030381	PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA	BTO	Substantially Equivalent	Portex , Ltd.	accessdata.fda.gov
August 19, 2003	K030407	ADVISOR, MODEL 9200	CCK	Substantially Equivalent	Bci, Inc.	accessdata.fda.gov
August 18, 2003	K031742	BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER	DQA	Substantially Equivalent	Bci, Inc.	accessdata.fda.gov
July 18, 2003	K031057	PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT	JOH	Substantially Equivalent	Portex, Inc.	accessdata.fda.gov
February 11, 2003	K023793	1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR	BTM	Substantially Equivalent	Portex, Inc.	accessdata.fda.gov
December 13, 2002	K020899	PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D	BTL	Substantially Equivalent	Pneupac , Ltd.	accessdata.fda.gov
August 13, 2002	K021999	GRIPPER PLUS NEEDLE	FPA	Substantially Equivalent	Deltec, Inc.	accessdata.fda.gov
June 3, 2002	K020739	BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR	DQA	Substantially Equivalent	Bci, Inc.	accessdata.fda.gov
April 30, 2002	K020350	BCI 3180 PULSE OXIMETER	DQA	Substantially Equivalent	Bci, Inc.	accessdata.fda.gov
February 27, 2002	K014115	1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX	BTM	Substantially Equivalent	Portex, Inc.	accessdata.fda.gov
February 13, 2002	K014073	HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE	FMF	Substantially Equivalent	Portex, Inc.	accessdata.fda.gov
January 3, 2002	K013171	3420 DIGIT PULSE OXIMETER, MODEL 3420	DQA	Substantially Equivalent	Bci, Inc.	accessdata.fda.gov
March 8, 2001	K010426	PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER	LJT	Substantially Equivalent	Sims Deltec, Inc.	accessdata.fda.gov
December 14, 2000	K002506	BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT	CAH	Substantially Equivalent	Sims Portex, Inc.	accessdata.fda.gov
December 5, 2000	K002768	ACAPELLA	BWF	Substantially Equivalent	Dhd Healthcare Corp.	accessdata.fda.gov
November 21, 2000	K003146	CLINIFLO INCENTIVE SPIROMETER	BWF	Substantially Equivalent	Dhd Healthcare Corp.	accessdata.fda.gov
September 18, 2000	K993282	IPI HUMIDIFIER CHAMBER	BTT	Substantially Equivalent	I.P.I. Medical Products	accessdata.fda.gov
April 28, 2000	K993619	CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK	BSP	Substantially Equivalent	Sims Portex, Inc.	accessdata.fda.gov
January 18, 2000	K991861	1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE	BTM	Substantially Equivalent	Sims Portex, Inc.	accessdata.fda.gov
October 22, 1999	K992471	SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18	BSO	Substantially Equivalent	Sims Portex, Inc.	accessdata.fda.gov
August 20, 1999	K990236	MODIFICATION OF JELCO,JELCO-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT	FOZ	Substantially Equivalent	Johnson & Johnson Medical, Div. of Ethicon, Inc.	accessdata.fda.gov
July 12, 1999	K991300	BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE	BWF	Substantially Equivalent	Dhd Healthcare Corp.	accessdata.fda.gov
June 9, 1999	K991086	CAPNOCHECK II, MODEL 8400	CCK	Substantially Equivalent	Bci Intl., Inc.	accessdata.fda.gov
April 2, 1999	K983467	THERAPEP	BWF	Substantially Equivalent	Dhd Healthcare Corp.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
May 12, 2026	99058	Class II	Ongoing	Plum administration sets	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.	accessdata.fda.gov
March 24, 2026	98622	Class II	Ongoing	Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960	Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiv	accessdata.fda.gov
December 19, 2025	98150	Class II	Ongoing	Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000	Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological	accessdata.fda.gov
October 2, 2025	97698	Class I	Ongoing	IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave	IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.	accessdata.fda.gov
September 8, 2025	97583	Class II	Ongoing	ChemoLock Bag Spike, 01 units REF: CL-10-10	Port weld of drug transfer device may separate or break during use and potentially result in a leak.	accessdata.fda.gov
June 3, 2025	96903	Class II	Ongoing	SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000	Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.	accessdata.fda.gov
November 6, 2024	95649	Class II	Ongoing	ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in pr	Due to finished goods incorrectly packaged and labeled.	accessdata.fda.gov
August 1, 2022	90726	Class II	Ongoing	MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.	Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.	accessdata.fda.gov
June 27, 2022	90606	Class II	Ongoing	Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 U	Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.	accessdata.fda.gov
March 16, 2021	87703	Class II	Ongoing	REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.	accessdata.fda.gov
December 2, 2020	86973	Class II	Terminated	60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of	Due to the incorrect filter assembly.	accessdata.fda.gov
November 9, 2020	86816	Class II	Terminated	icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognosti	Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.	accessdata.fda.gov
August 31, 2020	86426	Class II	Ongoing	42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml,	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.	accessdata.fda.gov
July 6, 2020	86054	Class II	Terminated	NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101(30)100(10)4447754 CLAVE Neutron is a normally closed, bidirectional co	Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.	accessdata.fda.gov
July 1, 2020	86075	Class II	Terminated	REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravascular administration	Incorrect filter assemblies in IV administration set.	accessdata.fda.gov
February 14, 2020	85329	Class II	Terminated	The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for w	Firm identified software issues which leads to the patient ID and patient information not being stored in the system.	accessdata.fda.gov
January 2, 2020	85361	Class II	Terminated	Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not	Inability for the guidewire to pass through the needles included with the catheter kits.	accessdata.fda.gov
October 4, 2019	85053	Class II	Terminated	REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475	There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to ser	accessdata.fda.gov
July 12, 2019	85300	Class II	Terminated	ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499	Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.	accessdata.fda.gov
February 21, 2019	82291	Class I	Terminated	icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental c	There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.	accessdata.fda.gov
January 3, 2019	81942	Class I	Terminated	icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and t	There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate	accessdata.fda.gov
November 27, 2018	81743	Class II	Terminated	ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO	Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.	accessdata.fda.gov
October 5, 2018	81210	Class II	Terminated	Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090	Potential for leakage due to defect in the thermoset check valve component.	accessdata.fda.gov
August 20, 2018	80946	Class II	Completed	ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of	Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.	accessdata.fda.gov
February 5, 2018	79077	Class II	Terminated	6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intr	The infusion sets were manufactured with an incorrect spin collar.	accessdata.fda.gov
January 5, 2018	79814	Class II	Terminated	Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac	When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.	accessdata.fda.gov
August 31, 2017	78191	Class II	Terminated	SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; 10" E	ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.	accessdata.fda.gov
July 31, 2017	80427	Class II	Terminated	119" Blood Set w/200 Micron Filter, Clave, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or veni	Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.	accessdata.fda.gov
May 30, 2017	77560	Class II	Terminated	18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration o	The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.	accessdata.fda.gov
November 30, 2016	75895	Class II	Terminated	133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which provides a	ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.	accessdata.fda.gov
September 27, 2016	75491	Class II	Terminated	4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.	accessdata.fda.gov
August 24, 2016	75093	Class II	Terminated	Tego Connector, Item No. D1000, NM1000 The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administrat	ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.	accessdata.fda.gov
August 10, 2016	74966	Class II	Terminated	Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.	accessdata.fda.gov
March 8, 2016	73528	Class II	Terminated	Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusi	ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.	accessdata.fda.gov
February 25, 2016	73391	Class II	Terminated	74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Bag Hanger, Item No. 011	ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.	accessdata.fda.gov
April 20, 2015	71028	Class II	Terminated	119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Admin	ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.	accessdata.fda.gov
August 19, 2014	69088	Class I	Terminated	STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdra	ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.	accessdata.fda.gov
August 5, 2014	68973	Class II	Terminated	CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch	ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.	accessdata.fda.gov
July 18, 2014	68971	Class II	Terminated	Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling por	ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.	accessdata.fda.gov
December 24, 2013	67166	Class II	Terminated	NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular ad	ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.	accessdata.fda.gov
September 28, 2012	63362	Class II	Terminated	3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.	ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.	accessdata.fda.gov
April 17, 2012	62538	Class II	Terminated	High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.	The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.	accessdata.fda.gov
March 1, 2011	60524	Not yet classified	Terminated	Orbit and Orbit Micro Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our devices within an oute	The recall was initiated because ICU Medical Inc. has become aware of the market recall of the Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names. The Triad alcohol prep pads have the potential contamination of the bacteria, Bacillus cereus. The Triad Group	accessdata.fda.gov
June 11, 2008	48681	Not yet classified	Terminated	Hospira Intralock Lipid Compatible 3-Way Stopcock, Item Number 423830401 Indicated for fluid flow directional control and for providing access port(s) for administration of solutions.	Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.	accessdata.fda.gov
September 26, 2006	38209	Not yet classified	Terminated	Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291	The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.	accessdata.fda.gov

Compare with other makers

Updated September 11, 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.