fda
530 records
FDA Device Recall: ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Ph
2026-01-28
Class II — Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from th...
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FDA Device Recall: Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF:
2026-01-28
Class II — 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, sep...
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FDA Device Recall: ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 40001100
2026-01-28
Class II — Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from th...
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FDA Device Recall: ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003
2026-01-28
Class II — Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from th...
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FDA Device Recall: Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1
2026-01-21
Class II — Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling ...
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FDA Recall: ICU Medical, Inc. — Class II
20251231
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. | Product: LifeShield Drug Library Management (DL...
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FDA Recall: ICU Medical, Inc. — Class II
20251105
Port weld of drug transfer device may separate or break during use and potentially result in a leak. | Product: ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
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FDA Recall: ICU Medical Inc. — Class II
20250910
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic hous | Product: Smiths Medical CADD Medication Cassett...
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FDA Recall: ICU Medical, Inc. — Class II
20250723
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, whic | Product: SwabCap Disinfecting Cap for Needlefre...
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FDA Device Recall: LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software S
2025-12-31
Class II — For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to re...
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FDA Device Recall: LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Su
2025-12-31
Class II — Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentrat...
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FDA Device Recall: ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical ChemosafeLock Connecter REF: KL-FNU3
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL33
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF:
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock D
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock P
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical ChemoLock Port REF: CL2100
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Po
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Ant
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical ChemoLock Bag Spike REF: CL-10
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical ChemoLock Closed Vial Spike REF: CL-80
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector,
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock D
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connecto
2025-11-05
Class II — Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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FDA Device Recall: IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Cl
2025-10-29
Class I — 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 deli...
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FDA Device Recall: Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. N
2025-09-10
Class II — Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication l...
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FDA Device Recall: Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and fema
2025-09-10
Class II — Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication l...
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FDA Device Recall: Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connec
2025-09-10
Class II — Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication l...
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FDA Device Recall: Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. No
2025-09-10
Class II — Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication l...
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FDA Device Recall: Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and fem
2025-09-10
Class II — Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication l...
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FDA Device Recall: Plum Duo Infusion System, List Number: 400020401
2025-08-13
Class I — ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
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FDA Device Recall: SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-200
2025-07-23
Class II — 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 evapo...
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FDA Drug Recall: POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, R
2025-03-19
Class I — Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
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FDA Drug Recall: POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 20
2025-03-19
Class I — Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq...
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FDA Device Recall: ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Dev
2024-12-18
Class II — Due to finished goods incorrectly packaged and labeled.
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FDA Device Recall: Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plu
2024-08-21
Class I — Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may d...
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FDA Recall: ICU Medical Inc — Class I
20230524
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than ex | Product: Replacement Battery List Number SUB000...
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FDA Recall: ICU Medical Inc — Class I
20230524
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than ex | Product: ASM Replacement Battery, Component Num...
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FDA Device Recall: Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, L
2023-05-24
Class I — Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may d...
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FDA Device Recall: ASM Replacement Battery, Component Number SUB0000864
2023-05-24
Class I — Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may d...
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FDA Device Recall: ASM Replacement Battery, Component Number SUB0000594
2023-05-24
Class I — Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may d...
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FDA Recall: ICU Medical, Inc. — Class II
20220921
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. | Product: 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros...
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FDA Recall: ICU Medical, Inc. — Class II
20220914
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside t | Product: Product Description/Item: ChemoLock Ba...
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU
2022-11-23
Class II — Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
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FDA Device Recall: 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros
2022-09-21
Class II — Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
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FDA Device Recall: MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave
2022-09-21
Class II — Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
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FDA Device Recall: 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check
2022-09-21
Class II — Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
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FDA Device Recall: MicroClave Clear Neutral Connector. A bidirectional connector used as an accesso
2022-09-21
Class II — Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
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FDA Device Recall: 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv
2022-09-21
Class II — Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
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FDA Device Recall: Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG
2022-09-14
Class II — 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 thera...
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FDA Device Recall: Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag
2022-09-14
Class II — 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 thera...
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FDA Recall: ICU Medical, Inc. — Class II
20210519
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 t | Product: REF CL3946 Oncology Kit w/5" (13 cm) A...
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FDA Recall: ICU Medical, Inc. — Class II
20210519
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 t | Product: REF CH2060 60mL Syringe w/Spinning Spi...
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FDA Recall: ICU Medical, Inc. — Class II
20210519
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 t | Product: REF CH3011 30" (76 cm) Appx 3.3 mL, 2...
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FDA Drug Recall: AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible conta
2021-09-22
Class I — Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
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FDA Device Recall: REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vente
2021-05-19
Class II — 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.
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FDA Device Recall: REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides acc
2021-05-19
Class II — 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.
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FDA Device Recall: REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave D
2021-05-19
Class II — 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.
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FDA Device Recall: REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoL
2021-05-19
Class II — 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.
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FDA Device Recall: REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT
2021-05-19
Class II — 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.
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FDA Device Recall: REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 512
2021-05-19
Class II — 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.
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FDA Device Recall: REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip
2021-05-19
Class II — 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.
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FDA Device Recall: REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock
2021-05-19
Class II — 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.
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FDA Device Recall: REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for th
2021-05-19
Class II — 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.
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FDA Device Recall: REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUS
2021-05-19
Class II — 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.
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FDA Device Recall: REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spi
2021-05-19
Class II — 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.
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FDA Device Recall: REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT,
2021-05-19
Class II — 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.
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FDA Device Recall: REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip C
2021-05-19
Class II — 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.
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FDA Device Recall: REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinn
2021-05-19
Class II — 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.
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FDA Device Recall: REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vente
2021-05-19
Class II — 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.
View Source
FDA Device Recall: REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock D
2021-05-19
Class II — 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.
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FDA Device Recall: REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Pr
2021-05-19
Class II — 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.
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FDA Drug Recall: 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufac
2021-03-31
Class II — Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
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FDA Device Recall: 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filt
2021-02-17
Class II — Due to the incorrect filter assembly.
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FDA Device Recall: 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: Th
2021-02-17
Class II — Due to the incorrect filter assembly.
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FDA Device Recall: 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product U
2021-02-17
Class II — Due to the incorrect filter assembly.
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FDA Device Recall: icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for p
2021-01-20
Class II — Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
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FDA Recall: ICU Medical, Inc. — Class II
20201230
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contami | Product: 30" (76 cm) Appx 3.3 ml, 20 Drop Admin...
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FDA Recall: ICU Medical, Inc. — Class II
20201230
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contami | Product: 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD...
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FDA Recall: ICU Medical, Inc. — Class II
20201230
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contami | Product: 42 IN (107 cm) Appx 5.0 ml, 20 Drop Ad...
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FDA Recall: ICU Medical, Inc. — Class II
20201028
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibi | Product: APPX 0.75ml, 6-Port NanoClave Manifold...
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FDA Recall: ICU Medical, Inc. — Class II
20201028
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibi | Product: 126" (320 cm) 16.4 ml, 15 Drop Primary...
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FDA Recall: ICU Medical, Inc. — Class II
20201028
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibi | Product: 7" (18 cm) Appx 0.29 ml, Smallbore Ext...
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FDA Recall: ICU Medical, Inc. — Class II
20201028
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibi | Product: 112" (284 cm) 60 Drop 150ml Burette Se...
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FDA Recall: ICU Medical, Inc. — Class II
20201028
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibi | Product: 7 IN (18CM) APPX 0.26ml, SMALLBORE EXT...
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FDA Recall: ICU Medical, Inc. — Class II
20201028
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibi | Product: Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ ...
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FDA Recall: ICU Medical, Inc. — Class II
20201028
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibi | Product: 83" (211 cm) Smallbore Ext Set w/Remv ...
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FDA Recall: ICU Medical, Inc. — Class II
20201028
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibi | Product: 13 IN (33cm) APPX 0.96 ml, PENTAFUSE S...
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FDA Recall: ICU Medical, Inc. — Class II
20201028
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibi | Product: 13 IN(33cm) APPX 1.0 ml, SMALLBORE SET...
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FDA Recall: ICU Medical, Inc. — Class II
20201028
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibi | Product: 7" (18cm) Appx 0.31 ml, Smallbore Ext ...
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FDA Recall: ICU Medical, Inc. — Class II
20200520
Inability for the guidewire to pass through the needles included with the catheter kits. | Product: Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial
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FDA Recall: ICU Medical, Inc. — Class II
20200513
Firm identified software issues which leads to the patient ID and patient information not being stored in the system. | Product: The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 0084061909...
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FDA Recall: ICU Medical, Inc. — Class II
20200513
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. | Product: REF: Z2812, 121" 10 Drop Primary Set w...
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FDA Device Recall: 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber,
2020-12-30
Class II — 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 h...
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FDA Device Recall: 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z279
2020-12-30
Class II — 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 h...
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FDA Device Recall: 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm
2020-12-30
Class II — 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 h...
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FDA Device Recall: Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") A
2020-12-30
Class II — 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 h...
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FDA Device Recall: 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2
2020-12-30
Class II — 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 h...
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FDA Device Recall: 5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm)
2020-12-30
Class II — 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 h...
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FDA Device Recall: Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
2020-12-30
Class II — 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 h...
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FDA Device Recall: 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Cha
2020-12-30
Class II — 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 h...
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FDA Device Recall: 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spir
2020-12-30
Class II — 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 h...
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FDA Device Recall: Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5
2020-12-30
Class II — 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 h...
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FDA Device Recall: 31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber,
2020-12-30
Class II — 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 h...
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FDA Device Recall: REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave C
2020-12-09
Class II — Incorrect filter assemblies in IV administration set.
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FDA Device Recall: APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BC
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-W
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp,
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit
2020-10-28
Class II — 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 spik...
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FDA Device Recall: Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ Stopcock w/Basepla
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clea
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Fi
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroCla
2020-10-28
Class II — 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 spik...
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FDA Device Recall: DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotat
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit pe
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Valve.
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv
2020-10-28
Class II — 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 spik...
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FDA Device Recall: Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)108877
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouc
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating L
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 un
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 C
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit pe
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yello
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-I
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClav
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2
2020-10-28
Class II — 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 spik...
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FDA Device Recall: NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)1
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, F
2020-10-28
Class II — 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 spik...
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FDA Device Recall: NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case.
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 un
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouc
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 u
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Cla
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector, N
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 uni
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Cla
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per p
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 un
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv Mi
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPC
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. 1 u
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroC
2020-10-28
Class II — 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 spik...
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FDA Device Recall: NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)1
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clam
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave.
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 C
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port Nan
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Micr
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouc
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pou
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per p
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 C
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 m
2020-10-28
Class II — 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 spik...
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FDA Device Recall: NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)108
2020-10-28
Class II — 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 spik...
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FDA Device Recall: 135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stop
2020-10-28
Class II — 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 spik...
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FDA Drug Recall: LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, I
2020-05-27
Class I — Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
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FDA Device Recall: Central Venous Catheters are indicated for the assessment of hemodynamic status
2020-05-20
Class II — Inability for the guidewire to pass through the needles included with the catheter kits.
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FDA Device Recall: Central Venous Catheters are indicated for the assessment of hemodynamic status
2020-05-20
Class II — Inability for the guidewire to pass through the needles included with the catheter kits.
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FDA Device Recall: The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF
2020-05-13
Class II — Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
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FDA Device Recall: REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks
2020-05-13
Class II — 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 ...
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FDA Device Recall: REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Press
2020-05-13
Class II — 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 ...
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FDA Device Recall: REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pr
2020-05-13
Class II — 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 ...
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FDA Device Recall: REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifol
2020-05-13
Class II — 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 ...
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FDA Recall: ICU Medical Inc — Class II
20191023
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | Product: Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets wit...
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FDA Drug Recall: 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, I
2019-11-13
Class I — Presence of Particulate Matter.
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FDA Drug Recall: LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, I
2019-11-13
Class I — Presence of Particulate Matter.
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FDA Device Recall: Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets wit
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
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FDA Device Recall: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
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FDA Device Recall: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
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FDA Device Recall: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets wit
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets wit
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets wit
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets wit
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets wit
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets wit
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets
2019-10-23
Class II — Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
View Source
FDA Device Recall: icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b
2019-04-24
Class I — 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.
View Source
FDA Device Recall: SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administrati
2019-04-24
Class I — 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.
View Source
FDA Device Recall: icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administr
2019-04-24
Class I — 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.
View Source
FDA Device Recall: icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administ
2019-04-24
Class I — 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.
View Source
FDA Device Recall: icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduate
2019-04-24
Class I — 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.
View Source
FDA Device Recall: ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samplin
2019-04-03
Class II — 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 therap...
View Source
FDA Device Recall: ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samplin
2019-04-03
Class II — 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 therap...
View Source
FDA Drug Recall: 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospir
2019-02-27
Class II — CGMP Deviations
View Source
FDA Device Recall: Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit
2019-01-02
Class II — Potential for leakage due to defect in the thermoset check valve component.
View Source
FDA Device Recall: Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Ca
2019-01-02
Class II — Potential for leakage due to defect in the thermoset check valve component.
View Source
FDA Device Recall: Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit
2019-01-02
Class II — Potential for leakage due to defect in the thermoset check valve component.
View Source
FDA Recall: ICU Medical, Inc. — Class II
20180815
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. | Product: 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Sto...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20180815
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. | Product: 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿,...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20180815
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. | Product: 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-W...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20180815
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. | Product: Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Conn...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20180815
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. | Product: 132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Rem...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20180418
The infusion sets were manufactured with an incorrect spin collar. | Product: 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Lue
View Source
FDA Device Recall: SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch
2018-12-26
Class II — There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
View Source
FDA Drug Recall: 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 m
2018-11-14
Class II — Lack of Assurance of Sterility; bags have the potential to leak
View Source
FDA Drug Recall: 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 04
2018-11-14
Class II — Lack of Assurance of Sterility; bags have the potential to leak
View Source
FDA Device Recall: ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 1
2018-10-10
Class II — 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 ...
View Source
FDA Device Recall: 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopco
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Ro
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connect
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿,
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopc
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Rem
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿,
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Port
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿,
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports,
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile Th
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 C
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Mi
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 2
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave¿,
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Lu
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Clear,
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Ste
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Sto
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, St
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a si
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Device Recall: 135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-
2018-08-15
Class II — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
View Source
FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake For
2018-06-27
Class II — Lack of assurance of sterility: Bags have potential to leak.
View Source
FDA Drug Recall: 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 6
2018-06-27
Class II — Lack of assurance of sterility: Bags have potential to leak.
View Source
FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake For
2018-06-27
Class II — Lack of assurance of sterility: Bags have potential to leak.
View Source
FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake For
2018-06-27
Class II — Lack of assurance of sterility: Bags have potential to leak.
View Source
FDA Drug Recall: 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Fo
2018-06-27
Class II — Lack of assurance of sterility: Bags have potential to leak.
View Source
FDA Device Recall: 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector,
2018-04-18
Class II — The infusion sets were manufactured with an incorrect spin collar.
View Source
FDA Device Recall: 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp,
2018-04-18
Class II — The infusion sets were manufactured with an incorrect spin collar.
View Source
FDA Device Recall: 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating
2018-04-18
Class II — The infusion sets were manufactured with an incorrect spin collar.
View Source
FDA Recall: ICU Medical, Inc. — Class II
20170719
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak. | Product: 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Ye...
View Source
FDA Device Recall: ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbe
2017-12-13
Class II — Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) w...
View Source
FDA Device Recall: SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Dro
2017-11-29
Class II — ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.
View Source
FDA Drug Recall: 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, H
2017-08-23
Class II — Presence of Particulate Matter; stainless steel
View Source
FDA Device Recall: 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Y
2017-07-19
Class II — The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
View Source
FDA Device Recall: 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating
2017-07-19
Class II — The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
View Source
FDA Device Recall: 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold
2017-07-19
Class II — The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
View Source
FDA Device Recall: 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 Nano
2017-07-19
Class II — The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
View Source
FDA Device Recall: 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Nan
2017-07-19
Class II — The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
View Source
FDA Device Recall: 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Lu
2017-01-18
Class II — 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.
View Source
FDA Device Recall: Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is
2017-01-18
Class II — ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: CATH LAB KIT, Item No. 46096-25 The Tran...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: Transpac¿ IV Bifurcated Monitoring Kit w/...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: TRIFURCATED MK W/03ML FLUSH DEVICE FOR UN...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: TRANSPAC¿ IV MONITORING KIT WITH SAFESET"...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: TRANSPAC¿ IV MONITORING KIT NEONATAL, 24...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: MONITORING KIT W/03ML FLUSH DEVICE FOR PI...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: MONITORING KIT WITH 03ML FLUSH DEVICE FOR...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: TRANSPAC¿ IV MONITORING KIT, DISPOSABLE ...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: TRANSPAC¿ IV MONITORING KIT, 60", DISPOSA...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: MONITORING KIT W/30 ML FLUSH DEVICE FOR E...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACK...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: Cath Lab Kit w/3 Port "ON" Manifold (600 ...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: TRANSPAC¿ IV MONITORING KIT, 9", DISPOSA...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: BIFURCATED KIT W/03ML FLUSH DEVICE FOR DU...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLIN...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: Monitoring Kit #3 w/03 ml Flush Device fo...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: TRANSPAC¿ IV MONITORING KIT , 60", DISPOS...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: PERFUSION KIT FOR UNIV. OF IOWA, Item No....
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: CATH LAB KIT w/4 PORT "ON" MANIFOLD, WAST...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FL...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: TRANSPAC¿ IV MONITORING KIT, 60", DISPOSA...
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FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR O...
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FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: OPEN HEART KIT W/03ML FLUSH DEVICE FOR CU...
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FDA Recall: ICU Medical, Inc. — Class II
20161123
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: Transpac¿ IV Monitoring Kit, 60", Disposa...
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FDA Recall: ICU Medical, Inc. — Class II
20160921
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: Monitoring Kit with 30mL Flush Device, I...
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FDA Recall: ICU Medical, Inc. — Class II
20160921
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: Transpac IV Monitoring Kit with SafeSet ...
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FDA Recall: ICU Medical, Inc. — Class II
20160921
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: Monitoring Kit with TP4, 30 ml Squeeze F...
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FDA Recall: ICU Medical, Inc. — Class II
20160921
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: Transpac IV Monitoring Kit with 2 SafeSe...
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FDA Recall: ICU Medical, Inc. — Class II
20160921
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Product: Transpac IV Monitoring Kit with SafeSet ...
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FDA Device Recall: CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Trans
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings,
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 T
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84"
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19 T
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 Th
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Dispo
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRI
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MIC
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 The T
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. 460
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HO
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 The
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac¿ IV, 2 Admin Sets and 8
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MA
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 The T
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpa
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 Th
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT , 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH,
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: PERFUSION KIT FOR UNIV. OF IOWA, Item No. 46091-51 The Transpac Disposable Stra
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: CATH LAB KIT w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MA
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-4
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-0
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo¿ Flush,
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ IV Monitoring Kit w/Safeset 72" Pressure Tubing, Reservoir, 03 ml Sque
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER, Item No
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-2
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 460
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQU
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Trifurcated Transpac¿ IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoir a
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Bifurcated Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blu
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Cath Lab Kit w/3 Port "ON" Manifold, 03 ml Flush Device, Waste Bag, HPT, Syringe
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 The Transpac D
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The Tr
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MAC
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressu
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: 2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOP
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: CATH LAB KIT FOR GENESIS HEALTH CARE, Item No. 46089-74 The Transpac Disposable
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, B
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: CATH LAB KIT W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-N
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 The Transpac Dispos
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Trans
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial S
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 M
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Monitoring Kit w/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way St
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Str
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE,
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-0
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" T
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transp
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 460
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV DISPOSABLE TRANSDUCER, Item No. 42582-05 The Transpac Disposable S
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 Th
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM ST
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: SINGLE LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-2
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Cath Lab Kit w/Waste Bag, dyePod¿, Sosa Spike & Syringe, Item No. 46098-11 The
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Trifurcated Monitoring Kit w/84" Safeset" Reservoir, TP4, 03 ml Squeeze Flush an
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device,
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-1
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT WITH 2 SAFESET" BLOOD SAMPLING PORTS, 60" TUBING, DI
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 The Transpac Disposabl
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HO
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No. 4
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: BIFURCATED TRANSPAC¿ 4 WITH 03ML FLUSH DEVICE FOR BUFFALO GENERAL HOSP., Item No
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ 4 kit w/72" Macrodrip¿ Admin Set, Item No. 46099-77 The Transpac Disp
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK, Item
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV TRIFURCATED MONITORING KIT 72", 3 DISPOSABLE TRANSDUCERS, 3 3 ML IN
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML IN
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCERS, 2 3 ML
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: RIGHT HEART CATH LAB KIT FOR BAPTIST MEM. HOSP., Item No. 46071-40 The Transpac
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84"
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Mac
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRIPLE PRESSURE KIT WITH 03ML FLUSH DEVICE FOR METHODIST M.C. OF ILLINOIS, Item
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP, Item No. 46095-22 The Trans
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18 The Transpac D
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush and Macrodrip, Item No. 46106-
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: Transpac¿ IV Bifurcated Monitoring Kit 48", 2 Disposable Transducers, 2 03 ml In
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: CATH LAB KIT FOR BAPTIST M. C., Item No. 46078-52 The Transpac Disposable Strai
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposa
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19 The Transpac Disposabl
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-0
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13 The
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac¿ IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Rese
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHO
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60"
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: TRANSPAC¿ IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STO
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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FDA Device Recall: LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure Tr
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 The
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: TRANSPAC¿ IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 STO
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: TRANSPAC¿ IV DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3mL
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, Item No. 4
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: DOUBLE LINE KIT WITH 03ML FLUSH DEVICE FOR UNIVERSITY OF MICHIGAN HOSP., Item No
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac¿ IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pr
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: TRANSPAC¿ IV MONITORING KIT WITH 2 BONDED STOPCOCKS, 72", DISPOSABLE TRANSDUCER
2016-11-23
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: Th
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservo
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 4610
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disp
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" T
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 8
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: 5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpa
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoi
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Need
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needle
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Us
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir,
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product U
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampli
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml S
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports,
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usa
2016-09-21
Class II — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
View Source
FDA Device Recall: Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana
2016-04-20
Class II — 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.
View Source
FDA Device Recall: Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH
2016-04-20
Class II — 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.
View Source
FDA Device Recall: Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Di
2016-04-20
Class II — 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.
View Source
FDA Device Recall: 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber
2016-04-06
Class II — 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 ...
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FDA Device Recall: 30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Ch
2016-04-06
Class II — 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 ...
View Source
FDA Device Recall: 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock
2016-04-06
Class II — 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 ...
View Source
FDA Device Recall: 31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Ch
2016-04-06
Class II — 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 ...
View Source
FDA Device Recall: 110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip
2016-04-06
Class II — 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 ...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20150513
ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. | Product: 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 C...
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FDA Recall: ICU Medical, Inc. — Class II
20150513
ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. | Product: 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Co...
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FDA Device Recall: 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, N
2015-05-13
Class II — ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
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FDA Device Recall: 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating
2015-05-13
Class II — ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
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FDA Device Recall: 113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Val
2015-05-13
Class II — ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
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FDA Device Recall: 104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trif
2015-05-13
Class II — ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
View Source
FDA Device Recall: 127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Val
2015-05-13
Class II — ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
View Source
FDA Device Recall: 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Va
2015-05-13
Class II — ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
View Source
FDA Device Recall: 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set
2015-05-13
Class II — ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
View Source
FDA Recall: ICU Medical, Inc. — Class II
20140813
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. | Product: Transpac IV Trifurcated Monitoring Kit w/84" Safeset R...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20140115
ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. | Product: 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20140115
ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. | Product: 5" Smallbore Ext Set w/MicroClave¿ T-Connect...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20140115
ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. | Product: 5" Smallbore Ext Set w/MicroClave¿ T-Connect...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20140115
ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. | Product: 78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Wa...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20140115
ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. | Product: 6" (15 cm) Appx 0.58 ml, Smallbore Trifuse E...
View Source
FDA Recall: ICU Medical, Inc. — Class II
20140115
ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. | Product: 103" (262 cm) Appx 3.9 ml, Smallbore Bifuse ...
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FDA Device Recall: STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clav
2014-10-01
Class I — ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
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FDA Device Recall: 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controll
2014-10-01
Class I — ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
View Source
FDA Device Recall: STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clav
2014-10-01
Class I — ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
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FDA Device Recall: Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled
2014-08-27
Class II — 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 steril...
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FDA Device Recall: Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled
2014-08-27
Class II — 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 steril...
View Source
FDA Device Recall: Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Fl
2014-08-13
Class II — 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.
View Source
FDA Device Recall: Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve a
2014-08-13
Class II — 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.
View Source
FDA Device Recall: Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blu
2014-08-13
Class II — 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.
View Source
FDA Device Recall: Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and
2014-08-13
Class II — 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.
View Source
FDA Device Recall: Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrod
2014-08-13
Class II — 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.
View Source
FDA Device Recall: Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm St
2014-08-13
Class II — 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.
View Source
FDA Device Recall: Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-
2014-08-13
Class II — 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.
View Source
FDA Device Recall: Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe
2014-08-13
Class II — 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.
View Source
FDA Device Recall: 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave"
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B3
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps, Ro
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon V
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, 2
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings), 4
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Lue
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Conne
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part N
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, An
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave¿
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-C
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender Ring
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Lue
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rota
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 78" Ext Set w/Check Valve, CLAVE¿ Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Lue
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Lue
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Lu
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Cla
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rota
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
View Source
FDA Device Recall: 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotatin
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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FDA Device Recall: 7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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FDA Device Recall: 8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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FDA Device Recall: 120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv CLAV
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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FDA Device Recall: NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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FDA Device Recall: 7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer,
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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FDA Device Recall: 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B3
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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FDA Device Recall: 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoClav
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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FDA Device Recall: 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, L
2014-01-15
Class II — ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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FDA Recall: ICU Medical, Inc. — Class II
20120808
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 occ | Product: Flush Kit w 3 Way Off Stopcock Prod...
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FDA Recall: ICU Medical, Inc. — Class II
20120808
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 occ | Product: 94" (239cm) 20 Drop Admin Set w/High P...
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FDA Device Recall: 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG
2012-10-17
Class II — 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.
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FDA Device Recall: Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
2012-08-08
Class II — 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.
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FDA Device Recall: 94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotatin
2012-08-08
Class II — 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.
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fda_adverse
2 records
FDA AE Manufacturer: ICU Medical, Inc.
Drug adverse event reporter — Product: SODIUM CHLORIDE
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FDA AE Manufacturer: ICU Medical Inc.
Drug adverse event reporter — Product: SODIUM CHLORIDE
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OSHA
1 records
OSHA Inspection (Referral) - Icu Medical Inc
2014-05-07
OSHA inspection at Icu Medical Inc, SALT LAKE CITY, UT. NAICS: 339112. SIC: 3841
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