Recall archive
55 recalls · page 2 of 3
Reported Mar 31, 2021
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical Inc.
Matched: Brand · Product · Product details — Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
FDA (openFDA drug enforcement)
Reported Feb 17, 2021
60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Due to the incorrect filter assembly.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 20, 2021
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Product · Product details — Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
FDA (openFDA device enforcement)
Reported Dec 30, 2020
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion,…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 9, 2020
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Product details — Incorrect filter assemblies in IV administration set.
FDA (openFDA device enforcement)
Reported Oct 28, 2020
NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit…
98 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2020
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Inability for the guidewire to pass through the needles included with the catheter kits.
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2020
REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — 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…
10 more products in this recall
FDA (openFDA device enforcement)
Reported May 6, 2020
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Product · Product details — Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate…
FDA (openFDA device enforcement)
Reported Apr 24, 2019
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical, Inc.
Matched: Brand · Product · Product details — There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2019
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Product · Product details — Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2019
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical, Inc.
Matched: Brand · Product · Product details — There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
FDA (openFDA device enforcement)
Reported Jan 2, 2019
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Potential for leakage due to defect in the thermoset check valve component.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 10, 2018
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported Aug 15, 2018
119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
52 more products in this recall
FDA (openFDA device enforcement)
Reported May 16, 2018
Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while…
FDA (openFDA device enforcement)
Reported Apr 18, 2018
6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Product details — The infusion sets were manufactured with an incorrect spin collar.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2017
SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Product details · Reason for recall — ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.
FDA (openFDA device enforcement)
Reported Jul 19, 2017
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand — The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 18, 2017
133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Reason for recall — 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.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2016
4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Reason for recall — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
161 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 21, 2016
Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Reason for recall — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
23 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2016
Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Reason for recall — ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 6, 2016
74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Reason for recall — ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock…
7 more products in this recall
FDA (openFDA device enforcement)
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