Agency classClass IIOur severity:High FDA (Devices)·Z-2719-2017·Announced 2017-07-19

ICU Medical Recalls 28 cm Smallbore Extension Sets Due to Leak Risk

ICU Medical is recalling 6 units of 28 cm Smallbore Extension Sets because the connection between the Female Luer and 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 is classified as FDA Class II, and the hazard involves a potential leak in a medical device used for vascular fluid administration, which poses a risk of harm to patients even though no specific injuries are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling 6 units of 28 cm (11") PUR Smallbore Extension Sets with 6-Port NanoClave Manifold, Check Valve, NanoClave, and Rotating Luer. The affected product is identified by Lot No. 3296247 and Item No. 011-AM6117. These devices are single-use, sterile, non-pyrogenic medical devices 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. This defect could compromise the integrity of the fluid administration system.

The affected units were distributed to Italy and France, as well as the following US states: Arizona, Ohio, Texas, and Washington. Healthcare facilities and patients who may have used these specific units should contact ICU Medical or their local FDA office for further instructions on how to proceed.

The recalled product

Product: 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, 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…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Administration Sets
Hazard: leak
fluid-contamination
Affected units: 6

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 (1)

Lot No. 3296247. Item No. 011-AM6117

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