ICU Medical Recalls
657 recalls on record · August 8, 2012 to July 29, 2026 · Drugs, Medical Devices
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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 18, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item
Hazard: The infusion sets were manufactured with an incorrect spin collar.
April 18, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile,
Hazard: The infusion sets were manufactured with an incorrect spin collar.
December 13, 2017Medical DevicesFDA
ICU Medical Inc recalls ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 160
Hazard: 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) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. Medication entries are built with the same displayed name and diluent amount AND; 2. The piggyback or interruptible settings differ from one CCA to another AND; 3. The drug library is exported then imported into the MedNet Meds program. The changed drug library may then be finalized and downloaded to infusers for use in clinical settings. The changes are made without any notice provided to either the MedNet Meds user (pharmacist) or to the clinician operating the infuser that the piggyback or interruptible settings have been altered. Issue 2: The MedNet Meds 6.1 program, under certain conditions different from those described above in Issue 1, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. The Master Drug Formulary contains medication entries built with the same displayed name and diluent amounts but one is a Limited rule set and the other is a Full rule set AND; 2. The medication entry built as the Full rule set has a blank medication amount with the medication units in mg AND; 3. Both medication entries have different piggyback options set AND; 4. The drug library is exported then imported into the MedNet Meds program. In this case, the piggyback options will be changed during an import of such drug library.
November 29, 2017Medical DevicesFDA
ICU Medical, Inc. recalls SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Lue
Hazard: ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.
November 22, 2017Medical DevicesFDA
ICU Medical Inc recalls Plum 360 Infusion System, List number 30010.
Hazard: (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.
August 23, 2017Medical DevicesFDA
ICU Medical Inc recalls Plum 360 Infusion System
Hazard: Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.
August 23, 2017DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA
Hazard: Presence of Particulate Matter; stainless steel
July 19, 2017Medical DevicesFDA
ICU Medical, Inc. recalls 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Fi
Hazard: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
July 19, 2017Medical DevicesFDA
ICU Medical, Inc. recalls 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is
Hazard: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
July 19, 2017Medical DevicesFDA
ICU Medical, Inc. recalls 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotati
Hazard: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
July 19, 2017Medical DevicesFDA
ICU Medical, Inc. recalls Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single use, sterile, non-pyrogenic devic
Hazard: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
July 19, 2017Medical DevicesFDA
ICU Medical, Inc. recalls PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Lu
Hazard: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
July 19, 2017Medical DevicesFDA
ICU Medical, Inc. recalls 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage
Hazard: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
July 19, 2017Medical DevicesFDA
ICU Medical, Inc. recalls 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage:
Hazard: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
July 19, 2017Medical DevicesFDA
ICU Medical, Inc. recalls 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotati
Hazard: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
July 19, 2017Medical DevicesFDA
ICU Medical, Inc. recalls 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage
Hazard: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
January 18, 2017Medical DevicesFDA
ICU Medical, Inc. recalls Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a v
Hazard: ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
January 18, 2017Medical DevicesFDA
ICU Medical, Inc. recalls 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Us
Hazard: 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.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pres
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls CATH LAB KIT W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-NS The Transpac Disposable Straight Pres
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 The Transpac Disposable Straight Pressure Transducer (DSP
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls 4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Tran
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac¿ IV, Waste Bag System and 10 cc Control Syringe, Ite
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac¿ IV, 2 Admin Sets and 8 cc Control Syringe, Item No. 46300-01 T
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way Stopcocks and Admin Set, Item No.
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Transpac¿ IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device, Macrodrip (Patien
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Transpac¿ IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device, Item No. 46113-91 The Transpac Disposa
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Transpac¿ IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe Tubing, Item No. 4
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Transpac¿ IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush Device, Needleless Valves, Red, Bl
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Transpac¿ IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 The Transpac Disposable Straight Pressure
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.