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.
April 6, 2016Medical DevicesFDA
ICU Medical, Inc. recalls 31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL30
Hazard: ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
April 6, 2016Medical DevicesFDA
ICU Medical, Inc. recalls 30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Han
Hazard: ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
April 6, 2016Medical DevicesFDA
ICU Medical, Inc. recalls 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, I
Hazard: ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
April 6, 2016Medical DevicesFDA
ICU Medical, Inc. recalls 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item
Hazard: ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
April 6, 2016Medical DevicesFDA
ICU Medical, Inc. recalls 110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hange
Hazard: ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
April 6, 2016Medical DevicesFDA
ICU Medical, Inc. recalls 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hang
Hazard: ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
April 6, 2016Medical DevicesFDA
ICU Medical, Inc. recalls 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Bag Hanger, Item No. 01
Hazard: ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
April 6, 2016Medical DevicesFDA
ICU Medical, Inc. recalls 74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are inte
Hazard: ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
May 13, 2015Medical DevicesFDA
ICU Medical, Inc. recalls 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Produc
Hazard: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
May 13, 2015Medical DevicesFDA
ICU Medical, Inc. recalls 98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rota
Hazard: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
May 13, 2015Medical DevicesFDA
ICU Medical, Inc. recalls 127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, I
Hazard: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
May 13, 2015Medical DevicesFDA
ICU Medical, Inc. recalls 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing,
Hazard: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
May 13, 2015Medical DevicesFDA
ICU Medical, Inc. recalls 113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroCl
Hazard: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
May 13, 2015Medical DevicesFDA
ICU Medical, Inc. recalls 104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valv
Hazard: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
May 13, 2015Medical DevicesFDA
ICU Medical, Inc. recalls 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041
Hazard: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
May 13, 2015Medical DevicesFDA
ICU Medical, Inc. recalls 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Chec
Hazard: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
October 1, 2014Medical DevicesFDA
ICU Medical, Inc. recalls 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648.
Hazard: ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
October 1, 2014Medical DevicesFDA
ICU Medical, Inc. recalls 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897
Hazard: ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
October 1, 2014Medical DevicesFDA
ICU Medical, Inc. recalls STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer
Hazard: ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
October 1, 2014Medical DevicesFDA
ICU Medical, Inc. recalls STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer
Hazard: ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
August 27, 2014Medical DevicesFDA
ICU Medical, Inc. recalls Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit wit
Hazard: ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.
August 27, 2014Medical DevicesFDA
ICU Medical, Inc. recalls Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with
Hazard: ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.
August 27, 2014Medical DevicesFDA
ICU Medical, Inc. recalls CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices
Hazard: ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.
August 13, 2014Medical DevicesFDA
ICU Medical, Inc. recalls Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpa
Hazard: 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.
August 13, 2014Medical DevicesFDA
ICU Medical, Inc. recalls Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38
Hazard: 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.
August 13, 2014Medical DevicesFDA
ICU Medical, Inc. recalls Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitor
Hazard: 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.
August 13, 2014Medical DevicesFDA
ICU Medical, Inc. recalls Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac
Hazard: 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.
August 13, 2014Medical DevicesFDA
ICU Medical, Inc. recalls Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac T
Hazard: 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.
August 13, 2014Medical DevicesFDA
ICU Medical, Inc. recalls Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46
Hazard: 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.
August 13, 2014Medical DevicesFDA
ICU Medical, Inc. recalls Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-4
Hazard: 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.