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

Surplug Nano Connector recalled by ICU Medical

ICU Medical is recalling Surplug Nano Connector, 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 Number:4476418.

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-0280-2021
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
Device type: Heart & Vascular Devices

Timeline

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

SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case. UDI:(01)54987892069913(17)221201(30)100(10)4476418. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patient s vascular system through the administrations set needle or catheter, which is inserted into the 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 Alabama Arizona California Colorado Delaware Florida Georgia Idaho Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina Nebraska

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 Number:4476418.

Where was it sold?

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.

Reported	Class	Recall	Company	Reason	Where
28 Oct 2020	CLASS II	APPX, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	126", 15 Drop Primary Set w/2 MicroClave Clear recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	7" Appx, Smallbore Ext Set w/MicroClave Clear, NanoClave recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	112" 60 Drop Burette Set (Clave, Shut-Off) w/2 MicroClave recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Smallbore Ext Set, MicroClave, Clave T-Connector recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	83" Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Pentafuse Smallbore Set, NanoClave, 3 MicroClave Clear recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Smallbore Set, 4 MicroClave Clear, NanoClave T-Conn, Filter recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	7" Appx, Smallbore Ext Set w/Remv MicroClave¿ Clear recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	6.5" Appx, Smallbore Pressure Infusion recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	114" 60 Drop Burette Set (Clave, Shut Off recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Distale - (80") Bifuse Ext Set w/6 Gang 1o2 Manifold recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	6" Appx, Smallbore Ext Set w/Clamp, NanoClave T-Connector recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX EXT SET NanoClave, 6-Port NanoClave Manifold . recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Smallbore Ext w/3-Port NanoClave Manifold, Check Valve recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	6.5" Appx, Smallbore Pressure Infusion recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Clave Stopcock recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Ext Set,NanoClave T-connector recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	9.5", Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, MicroClave Clear, 1.2v Filter Nanoclave T-conn recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Smallbore, Clave Stopcock, MicroCLAVE Clear recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	7.5" Appx, Smallbore Trifuse Ext Set w/3 MicroClave Clear recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	9" Appx, Smallbore Bifuse Ext Set w/2 MicroClave Clear recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	NanoClave Connector recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, Ext w/6-Port NanoClave Manifold, Check Valve recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	78" Appx, Ext Set, MicroClave Clear recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	NanoClave Stopcock w/NanoClave recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	11" Appx, Ext Set w/6-Port NanoClave Manifold, Check Valve recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	5.5" Appx, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, Smallbore Set 6-Port NanoClave Manifold recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	8.5" Appx, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	10" Appx, Trifuse Ext Set w/3 MicroClave¿ Clear recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	22" Appx, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	9.5" Appx, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Trifuse, Clave Stopcock, 2 Clave, Filter recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	7" Appx, Smallbore Pressure Infusion recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	7" Appx, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Pur Ext Set, 3-Port, NanoClave Manifold, Bcv, NanoClave recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, 15 Drop Set, 3 Clave, Remv 3 Gang 4-Way Clave Stopcock 2 Ext recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	40 Appx Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx Ext Set, NanoClave T-connector, Clamp, Rotating Luer recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	NanoClave Connector recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	12" Appx, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Pur Ext Set, 3-Port NanoClave Manifold, Bcv, NanoClave recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, 10 Drop, 2 Clave Stopcock, NanoClave T-Connector recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	139" 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	9.5" Appx, Smallbore Pressure Infusion recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, EXT SET w/3-Port NanoClave Manifold, Check Valve recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx,Smallbore, 2 NanoClave, Filter recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	3-Port NanoClave Manifold w/Check Valve, Rotating Luer recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, MicroClave Clear, NanoClave T-conn, Filter recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx Smallbore Trifuse Set,3 MicroClave Clear, NanoClave recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	NanoClave Connector recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	(53") Ext Set w/Remv 5 Gang Stopcock recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	7" Appx, Smallbore Ext Set w/MicroClave Clear, NanoClave recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	8" Appx, Smallbore Ext Set w/MicroClave Clear recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	6" Appx, Smallbore Ext Set w/MicroClave Clear, Clamp recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Smallbore Hexafuse Set, 6 MicroClave Clear recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	5" Appx, Smallbore Bifuse Ext Set w/NanoClave T-Connector recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, 6-Port NanoClave Manifold, Check Valve recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	109" Appx, Transfer Set w/Check Valve recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx 15 Drop Set 2 MicroClave, Remv 3-Port NanoClave Manifold, Bcv recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, 60 Drop Set, 2 Clave, Remv 2 Clave Stopcocks recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX Ext Set w/6-Port NanoClave Manifold, Check Valve recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	60" Appx, Smallbore Trifuse Ext Set w/3 MicroClave Clear recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, Ext, Stopcock, 3-Port NanoClave Manifold, MicroClave Clear recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, 15 Drop Set 4 MicroClave Clear, Remv 3-Port NanoClave w/ Bcv recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	5.5" Appx, Smallbore Trifuse Ext Set w/3 MicroClave" Clear recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Proximale Appx, Ext Set, 6-Port NanoClave Manifold, NanoClave recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, Ext w/3-Port NanoClave Manifold, Check Valve recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, EXT SET w/ NanoClave 4-Way Stopcock recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	113" Appx, 10 Drop Admin Set w/MicroClave" Clear recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	107" Appx, Smallbore Ext Set w/2 Check Valves recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	8" Appx, Smallbore Ext Set w/MicroClave Clear recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, 10 Drop Set w/3 MicroClave, 3-Port NanoClave recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	124" 60 Drop Burette Set (w/Clave, Shut-Off) recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx, 15 Drop Set, 2 Clave, Remv 3 Gang Clave Stopcock recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX EXT SET w NanoClave 4-Way Stopcock recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	5.5" Appx, Smallbore Trifuse Ext Set w/3 MicroClave Clear recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	Appx,Smallbore Set,NanoClave,6-Port NanoClave Manifold,Bcv recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	7" Appx, Smallbore Pressure Infusion recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	APPX EXT w/6-Port NanoClave Manifold, Check Valve recalled	ICU Medical	Packaging Defects	Nationwide
28 Oct 2020	CLASS II	128" Appx, 15 Drop Primary Set w/2 MicroClave recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide

More recalls from ICU Medical

All 654

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	Hotline Fluid Warming Set, single use device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
17 Jun 2026Device	CLASS II	Plum Solo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Infusion Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide

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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide