CLASS II Device recall · Reported 28 Oct 2020 · FDA Enforcement Report

3-Port NanoClave Manifold w/Check Valve, Rotating Luer recalled

ICU Medical is recalling 3-Port NanoClave Manifold w/Check Valve, Rotating Luer, distributed nationwide in the US. The recall was initiated on 6 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers:4556715, 4579939, 4592179, 4610925, 4547212, 4712946,4720392.
Quantity recalledTotal of all products (Listed #1 thru 101) = 304735 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0224-2021
FDA event ID
86054
Recalling firm
ICU Medical, San Clemente, CA
Classification
Class II
Status
Terminated
Recall initiated
6 Jul 2020
FDA classified
22 Oct 2020
Reported
28 Oct 2020
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Packaging Defects

Timeline

6 Jul 2020Recall initiated by company
22 Oct 2020Classified by FDA+108 days
28 Oct 2020Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50(10)4579939; (01)10887709087153(17)250101(30)50(10)4592179; (01)10887709087153(17)250101(30)50(10)4610925; (01)10887709087153(17)241201(30)50(10)4547212; (01)10887709087153(17)250101(30)50(10)4712946; (01)10887709087153(17)250201(30)50(10)4720392. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

Where it was distributed

Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

Nationwide AlabamaArizonaCaliforniaColoradoDelawareFloridaGeorgiaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNebraska

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lot Numbers:4556715, 4579939, 4592179, 4610925, 4547212, 4712946,4720392.

Where was it sold?

Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

98 other products · FDA event 86054

This product is part of a recall event; the main page for the event is APPX, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIAPPX, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple recalledICU MedicalPackaging DefectsNationwide
CLASS II126", 15 Drop Primary Set w/2 MicroClave Clear recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II7" Appx, Smallbore Ext Set w/MicroClave Clear, NanoClave recalledICU MedicalPackaging DefectsNationwide
CLASS II112" 60 Drop Burette Set (Clave, Shut-Off) w/2 MicroClave recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Smallbore Ext Set, MicroClave, Clave T-Connector recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer recalledICU MedicalPackaging DefectsNationwide
CLASS II83" Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Pentafuse Smallbore Set, NanoClave, 3 MicroClave Clear recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Smallbore Set, 4 MicroClave Clear, NanoClave T-Conn, Filter recalledICU MedicalPackaging DefectsNationwide
CLASS II7" Appx, Smallbore Ext Set w/Remv MicroClave¿ Clear recalledICU MedicalPackaging DefectsNationwide
CLASS II6.5" Appx, Smallbore Pressure Infusion recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II114" 60 Drop Burette Set (Clave, Shut Off recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave recalledICU MedicalPackaging DefectsNationwide
CLASS IIDistale - (80") Bifuse Ext Set w/6 Gang 1o2 Manifold recalledICU MedicalPackaging DefectsNationwide
CLASS II6" Appx, Smallbore Ext Set w/Clamp, NanoClave T-Connector recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX EXT SET NanoClave, 6-Port NanoClave Manifold . recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Smallbore Ext w/3-Port NanoClave Manifold, Check Valve recalledICU MedicalPackaging DefectsNationwide
CLASS II6.5" Appx, Smallbore Pressure Infusion recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIClave Stopcock recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Ext Set,NanoClave T-connector recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II9.5", Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, MicroClave Clear, 1.2v Filter Nanoclave T-conn recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Smallbore, Clave Stopcock, MicroCLAVE Clear recalledICU MedicalPackaging DefectsNationwide
CLASS II7.5" Appx, Smallbore Trifuse Ext Set w/3 MicroClave Clear recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks recalledICU MedicalPackaging DefectsNationwide
CLASS II9" Appx, Smallbore Bifuse Ext Set w/2 MicroClave Clear recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave recalledICU MedicalPackaging DefectsNationwide
CLASS IINanoClave Connector recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, Ext w/6-Port NanoClave Manifold, Check Valve recalledICU MedicalPackaging DefectsNationwide
CLASS II78" Appx, Ext Set, MicroClave Clear recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IINanoClave Stopcock w/NanoClave recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II11" Appx, Ext Set w/6-Port NanoClave Manifold, Check Valve recalledICU MedicalPackaging DefectsNationwide
CLASS II5.5" Appx, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, Smallbore Set 6-Port NanoClave Manifold recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIExt Set, MicroClave Clear, T-Connector, RLL, Approx PV recalledICU MedicalPackaging DefectsNationwide
CLASS II8.5" Appx, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter recalledICU MedicalPackaging DefectsNationwide
CLASS II10" Appx, Trifuse Ext Set w/3 MicroClave¿ Clear recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II22" Appx, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL recalledICU MedicalPackaging DefectsNationwide
CLASS II9.5" Appx, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Trifuse, Clave Stopcock, 2 Clave, Filter recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext recalledICU MedicalPackaging DefectsNationwide
CLASS II7" Appx, Smallbore Pressure Infusion recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II7" Appx, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Pur Ext Set, 3-Port, NanoClave Manifold, Bcv, NanoClave recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, 15 Drop Set, 3 Clave, Remv 3 Gang 4-Way Clave Stopcock 2 Ext recalledICU MedicalPackaging DefectsNationwide
CLASS II40 Appx Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx Ext Set, NanoClave T-connector, Clamp, Rotating Luer recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear recalledICU MedicalPackaging DefectsNationwide
CLASS IINanoClave Connector recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II12" Appx, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Pur Ext Set, 3-Port NanoClave Manifold, Bcv, NanoClave recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, 10 Drop, 2 Clave Stopcock, NanoClave T-Connector recalledICU MedicalPackaging DefectsNationwide
CLASS II139" 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock recalledICU MedicalPackaging DefectsNationwide
CLASS II9.5" Appx, Smallbore Pressure Infusion recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, EXT SET w/3-Port NanoClave Manifold, Check Valve recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx,Smallbore, 2 NanoClave, Filter recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIAppx, MicroClave Clear, NanoClave T-conn, Filter recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIAppx Smallbore Trifuse Set,3 MicroClave Clear, NanoClave recalledICU MedicalPackaging DefectsNationwide
CLASS II2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer recalledICU MedicalPackaging DefectsNationwide
CLASS IINanoClave Connector recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II(53") Ext Set w/Remv 5 Gang Stopcock recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II7" Appx, Smallbore Ext Set w/MicroClave Clear, NanoClave recalledICU MedicalPackaging DefectsNationwide
CLASS II8" Appx, Smallbore Ext Set w/MicroClave Clear recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIAppx, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer recalledICU MedicalPackaging DefectsNationwide
CLASS II6" Appx, Smallbore Ext Set w/MicroClave Clear, Clamp recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Smallbore Hexafuse Set, 6 MicroClave Clear recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II5" Appx, Smallbore Bifuse Ext Set w/NanoClave T-Connector recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, 6-Port NanoClave Manifold, Check Valve recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II109" Appx, Transfer Set w/Check Valve recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIAppx 15 Drop Set 2 MicroClave, Remv 3-Port NanoClave Manifold, Bcv recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, 60 Drop Set, 2 Clave, Remv 2 Clave Stopcocks recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX Ext Set w/6-Port NanoClave Manifold, Check Valve recalledICU MedicalPackaging DefectsNationwide
CLASS II60" Appx, Smallbore Trifuse Ext Set w/3 MicroClave Clear recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, Ext, Stopcock, 3-Port NanoClave Manifold, MicroClave Clear recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, 15 Drop Set 4 MicroClave Clear, Remv 3-Port NanoClave w/ Bcv recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap recalledICU MedicalPackaging DefectsNationwide
CLASS II5.5" Appx, Smallbore Trifuse Ext Set w/3 MicroClave" Clear recalledICU MedicalPackaging DefectsNationwide
CLASS IIProximale Appx, Ext Set, 6-Port NanoClave Manifold, NanoClave recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, Ext w/3-Port NanoClave Manifold, Check Valve recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, EXT SET w/ NanoClave 4-Way Stopcock recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II113" Appx, 10 Drop Admin Set w/MicroClave" Clear recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II107" Appx, Smallbore Ext Set w/2 Check Valves recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II8" Appx, Smallbore Ext Set w/MicroClave Clear recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx, 10 Drop Set w/3 MicroClave, 3-Port NanoClave recalledICU MedicalPackaging DefectsNationwide
CLASS IISurplug Nano Connector recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II124" 60 Drop Burette Set (w/Clave, Shut-Off) recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIAppx, 15 Drop Set, 2 Clave, Remv 3 Gang Clave Stopcock recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX EXT SET w NanoClave 4-Way Stopcock recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS II5.5" Appx, Smallbore Trifuse Ext Set w/3 MicroClave Clear recalledICU MedicalPackaging DefectsNationwide
CLASS IIAppx,Smallbore Set,NanoClave,6-Port NanoClave Manifold,Bcv recalledICU MedicalPackaging DefectsNationwide
CLASS IIAPPX, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV recalledICU MedicalPackaging DefectsNationwide
CLASS II7" Appx, Smallbore Pressure Infusion recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIAPPX EXT w/6-Port NanoClave Manifold, Check Valve recalledICU MedicalPackaging DefectsNationwide
CLASS II128" Appx, 15 Drop Primary Set w/2 MicroClave recalled by ICU MedicalICU MedicalPackaging DefectsNationwide

More recalls from ICU Medical

All 654
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIHotline Fluid Warming Set, single use device recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
DeviceCLASS IIPlum Solo Precision IV Pump, v1.0.3 recalled by ICU MedicalICU MedicalOtherNationwide
DeviceCLASS IIPlum Solo Precision IV Pump recalled by ICU MedicalICU MedicalDevice MalfunctionNationwide
DeviceCLASS IIPlum Duo Infusion Pump recalled by ICU MedicalICU MedicalDevice MalfunctionNationwide
DeviceCLASS IIPlum Duo Precision IV Pump recalled by ICU MedicalICU MedicalDevice MalfunctionNationwide

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DeviceCLASS IIGetinge PVC Thoracic Catheter, Soft PVC Right Angle recalledAtrium MedicalPotency & AssayNationwide
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