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ICU Medical, Inc. FDA Recalls

124 recalls on file across devices, drugs, 13 of them Class I and 122 still open. Matched by name to ICUI.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS ProducClass IIAug 20, 2026Reservoirs may exhibit medication leakage at the joint betwe
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the pClass IIJun 24, 2026ICU Medical became aware of an increased likelihood of leaka
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pumpClass IIJun 10, 2026In a specific scenario, the pump will not decrement the Volu
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pumpClass IIJun 10, 2026In a specific scenario, the pump will not decrement the Volu
Plum administration setsClass IIMay 12, 2026Intravascular administration tubing set drip chambers may ha
IV Sets with drip chambersClass IIMay 12, 2026Intravascular administration tubing set drip chambers may ha
IV Sets with drip chambersClass IIMay 12, 2026Intravascular administration tubing set drip chambers may ha
Oncology sets with drip chambersClass IIMay 12, 2026Intravascular administration tubing set drip chambers may ha
IV Sets with drip chambersClass IIMay 12, 2026Intravascular administration tubing set drip chambers may ha
Oncology sets with drip chambersClass IIMay 12, 2026Intravascular administration tubing set drip chambers may ha
IV Non-Dedicated Gravity Administration Sets with drip chambersClass IIMay 12, 2026Intravascular administration tubing set drip chambers may ha
IV Sets with drip chambersClass IIMay 12, 2026Intravascular administration tubing set drip chambers may ha
Plum Duo Infusion Pump, 40002-0401Class IIApr 29, 2026Under certain conditions, the pump may not display a soft li
Plum Solo Precision IV Pump, 40001-0401Class IIApr 29, 2026Under certain conditions, the pump may not display a soft li
Plum Duo Precision IV Pump, 40002-0403Class IIApr 29, 2026Under certain conditions, the pump may not display a soft li
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLockClass IIMar 24, 2026Oncology sets/closed system transfer devices with extension
Portex Spinal Tray, Item No. A3729-24 A3595Class IIDec 19, 2025Affected lots of syringes may have a crack on the syringe co
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PGClass IIDec 19, 2025Affected lots of syringes may have a crack on the syringe co
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000Class IIDec 19, 2025Needle free access device intended as accessory to vascular
Plum Duo Infusion System, List Number 40002-04-01Class IIDec 15, 2025ICU Medical received one lot of defective primary speakers f
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)Class IIDec 15, 2025Plum Solo and Duo Infusion pumps include a feature, that whe
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)Class IIDec 15, 2025Plum Solo and Duo Infusion pumps include a feature, that whe
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)Class IIDec 15, 2025Plum Solo and Duo Infusion pumps include a feature, that whe
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02Class IINov 24, 2025For certain customers, the Change Summary review option ceas
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02Class IINov 24, 2025Software issue only allows Concentration Limits to be define
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cmClass IOct 2, 2025IV Gravity burette administration set burette component is m
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, HangerClass IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NSClass IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ChemoLock Bag Spike, 01 units REF: CL-10-10Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemosafeLock Connecter REF: KL-FNU3Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock Closed Vial Spike REF: CL-80Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock Bag Spike REF: CL-10Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70SClass IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In ReClass IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock Port REF: CL2100Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemClass IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80SClass IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900Class IISep 8, 2025Port weld of drug transfer device may separate or break dur
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/CheClass IISep 8, 2025Port weld of drug transfer device may separate or break dur
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 10Class IIAug 6, 2025Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubinClass IIAug 6, 2025Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 5Class IIAug 6, 2025Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, ProductClass IIAug 6, 2025Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs
Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper inclClass IIAug 6, 2025Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, ProduClass IIAug 6, 2025Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs
Plum Duo Infusion System, List Number: 400020401Class IJul 11, 2025ICU Medical identified two sequences of programming events a
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-200Class IIJun 3, 2025Due to a manufacturing issue, disinfecting cap for needle-fr
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2Class IIMay 2, 2025Firm has identified Drug Library Management defects in the s
ICU Medical Plum Solos, Item number 400011001; infusion pumpClass IIApr 22, 2025Internal testing found that Plum Duo pumps with software ver
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pumpClass IIApr 22, 2025Internal testing found that Plum Duo pumps with software ver
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Class IFeb 13, 2025Labeling: Label Error on Declared Strength. Overwrap labeled
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., LakClass IFeb 13, 2025Labeling: Label Error on Declared Strength. Cases labeled PO
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmentClass IINov 6, 2024Due to finished goods incorrectly packaged and labeled.
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" InfusionClass IOct 22, 2024ICU Medical has received reports of allegedly counterfeit CS
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List NumberClass IMay 7, 2024Due to a manufacturing defect from the battery supplier, aff
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description isClass IMay 7, 2024Due to a manufacturing defect from the battery supplier, aff
Plum 360/A+ spare batteries. Item Number: SUB0000864.Class IMay 7, 2024Due to a manufacturing defect from the battery supplier, aff
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 30Class IIJul 13, 2023Due to a manufacturing defect of a supplier provided compone
ASM Replacement Battery, Component Number SUB0000594Class IMar 22, 2023Due to a manufacturing defect from the battery supplier, aff
ASM Replacement Battery, Component Number SUB0000864Class IMar 22, 2023Due to a manufacturing defect from the battery supplier, aff
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 1197Class IMar 22, 2023Due to a manufacturing defect from the battery supplier, aff
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010Class IMar 22, 2023Due to a manufacturing defect from the battery supplier, aff
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 6Class IINov 9, 2022Lack of assurance of sterility: Bags have the potential to l
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed iClass IIAug 1, 2022Due to a manufacturing defect which results in a visible gap
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx PrimingClass IIAug 1, 2022Due to a manufacturing defect which results in a visible gap
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascuClass IIAug 1, 2022Due to a manufacturing defect which results in a visible gap
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;Class IIAug 1, 2022Due to a manufacturing defect which results in a visible gap
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, RotatClass IIAug 1, 2022Due to a manufacturing defect which results in a visible gap
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;Class IIAug 1, 2022Due to a manufacturing defect which results in a visible gap
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag SpikeClass IIJun 27, 2022Ports have a potential for unintended disconnection, inabili
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12Class IIJun 27, 2022Ports have a potential for unintended disconnection, inabili
AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake ForeClass ISep 3, 2021Presence of Particulate Matter: Particulate matter identifie
REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides aClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the adminiClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: providClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a contaiClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3Class IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag HangClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/ReClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides accesClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a coClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the Class IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides aClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, SpirClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids froClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the admClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Class IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/ReClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a Class IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Class IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a containerClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros Class IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 514297Class IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids froClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluidClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple CaClass IIMar 16, 2021Due to molding defect, there is a potential that certain lot
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake ForestClass IIMar 9, 2021Presence of particulate matter.one confirmed customer repor

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