Agency classClass IIOur severity:High FDA (Devices)·Z-2798-2018·Announced 2018-08-22

ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (leak/separation) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical de Mexico, S.A. de C.V. is expanding the scope of a previously initiated recall to include additional I.V. Administration Sets with NanoClave manifolds. The affected products are 165 cm (65") PUR Smallbore Extension Sets with 3-Port NanoClave Manifold, Check Valve, NanoClave, and Rotating Luer. These are single-use, sterile, non-pyrogenic devices used to provide access for the administration of fluids from a container to a patient's vascular system.

The recall is being conducted due to the potential for the device to develop a leak or for separation to occur between the female luer and the NanoClave manifold. The specific item number is 011-AM3003, with Lot Number 3297342 and an expiration date of 07/01/2021. The quantity involved is 50 pouches.

The affected products were distributed in the United States to Arizona, Massachusetts, North Carolina, Ohio, Texas, Virginia, and Washington. They were also distributed worldwide to Belgium, France, and Germany. Consumers and healthcare facilities should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product: 165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
Manufacturer: ICU Medical de Mexico, S.A. de C.V.
Category: Medical Device — I.V. Administration Sets
Hazard: leak
component-separation
Affected units: 50

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Item Number 011-AM3003. Lot Number 3297342
UDI Number (01) 1 0840619 09275 1 (17) 210700 (30) 50 (10) 3597342
Expiration Date 07/01/2021.

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 20 recalled by ICU Medical de Mexico, S.A. de C.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

Same manufacturer · ICU Medical de Mexico, S.A. de C.V.

See all →

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ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
FDA (Devices) · 2018-08-22
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ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk
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ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
FDA (Devices) · 2018-08-22
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ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
FDA (Devices) · 2018-08-22
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ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
FDA (Devices) · 2018-08-22

Same hazard · leak