Agency classClass IIOur severity:High FDA (Devices)·Z-2722-2017·Announced 2017-07-19

ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk

ICU Medical is recalling 900 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

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 potential leak hazard that could compromise sterility or fluid delivery, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling 900 units of 10-inch Smallbore Extension Sets with 6-Port NanoClave Manifold. The recall involves specific lots (3040897, 3085194, 3100137, 3125469, 3136083, 3284928, 3288396, 3309182) and Item No. AM6100. These devices are single-use, sterile, non-pyrogenic products used to provide access for the administration of fluids from a container to a patient's vascular system.

The recall was initiated because the connection between the Female Luer and the NanoClave manifold has the potential for developing a leak. The affected products were distributed to Italy and France, as well as the following US states: Arizona, Ohio, Texas, and Washington.

Healthcare facilities and consumers should stop using the affected extension sets immediately. Users should contact ICU Medical, Inc. for further instructions on how to return or dispose of the recalled devices.

The recalled product

Product: 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, 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…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Administration Sets
Hazard: leak
contamination
Affected units: 900

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 (8)

Lot No. 3040897
3085194
3100137
3125469
3136083
3284928
3288396
3309182. Item No. AM6100

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 9 recalled by ICU Medical, Inc. 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 9 products in this recall →

Same manufacturer · ICU Medical, Inc.

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Same hazard · leak