ICU Medical Recalls
657 recalls on record · August 8, 2012 to July 29, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Cla
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 m
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouche
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouche
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per p
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Conne
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Con
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Tri
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purpl
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connect
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multi
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector, NanoClave¿ T-Connector, 4 Clamps (Red, Wh
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 mul
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(1
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per p
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
October 28, 2020Medical DevicesFDA
ICU Medical, Inc. recalls NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051;
Hazard: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
May 27, 2020DrugsFDA
ICU Medical Inc recalls LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-795
Hazard: Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
May 20, 2020Medical DevicesFDA
ICU Medical, Inc. recalls Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,
Hazard: Inability for the guidewire to pass through the needles included with the catheter kits.
May 20, 2020Medical DevicesFDA
ICU Medical, Inc. recalls Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,
Hazard: Inability for the guidewire to pass through the needles included with the catheter kits.
May 20, 2020Medical DevicesFDA
ICU Medical, Inc. recalls Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,
Hazard: Inability for the guidewire to pass through the needles included with the catheter kits.
May 20, 2020Medical DevicesFDA
ICU Medical, Inc. recalls Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,
Hazard: Inability for the guidewire to pass through the needles included with the catheter kits.
May 20, 2020Medical DevicesFDA
ICU Medical, Inc. recalls Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,
Hazard: Inability for the guidewire to pass through the needles included with the catheter kits.
May 20, 2020Medical DevicesFDA
ICU Medical, Inc. recalls Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,
Hazard: Inability for the guidewire to pass through the needles included with the catheter kits.