CLASS II Device recall · Reported 19 Jul 2017 · FDA Enforcement Report

Proximale - (11") Smallbore Ext Set w/6-Port NanoClave¿ recalled

ICU Medical is recalling Proximale - (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, distributed in Arizona, Ohio, Texas, Washington. The recall was initiated on 30 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 3316827. Item No. 011-AM6118

Quantity recalled70 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-2720-2017
FDA event ID: 77560
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 30 May 2017
FDA classified: 11 Jul 2017
Reported: 19 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

30 May 2017	Recall initiated by company
11 Jul 2017	Classified by FDA	+42 days
19 Jul 2017	Published in enforcement report	+8 days

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

Reason for recall

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

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

PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)..

Where it was distributed

Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.

Arizona Ohio Texas Washington

Questions about this recall

Why was it recalled?

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

Which lots are affected?

Lot No. 3316827. Item No. 011-AM6118

Where was it sold?

Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.

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

8 other products · FDA event 77560

This product is part of a recall event; the main page for the event is 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange recalled.

Reported	Class	Recall	Company	Reason	Where
19 Jul 2017	CLASS II	10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange recalled	ICU Medical	Packaging Defects	4 states
19 Jul 2017	CLASS II	10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold recalled	ICU Medical	Packaging Defects	4 states
19 Jul 2017	CLASS II	(66") Appx, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ recalled	ICU Medical	Packaging Defects	4 states
19 Jul 2017	CLASS II	(11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold recalled	ICU Medical	Packaging Defects	4 states
19 Jul 2017	CLASS II	(11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold recalled	ICU Medical	Packaging Defects	4 states
19 Jul 2017	CLASS II	(7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold recalled	ICU Medical	Packaging Defects	4 states
19 Jul 2017	CLASS II	10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange recalled	ICU Medical	Packaging Defects	4 states
19 Jul 2017	CLASS II	Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear recalled by ICU Medical	ICU Medical	Packaging Defects	4 states

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

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
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