Agency classClass IIOur severity:High FDA (Devices)·Z-2720-2017·Announced 2017-07-19

ICU Medical Recalls Proximale Smallbore Extension Sets Due to Leak Risk

ICU Medical is recalling 70 units of Proximale 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 device used for vascular fluid administration, which poses a risk of harm to patients even though specific injuries are not reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling 70 units of the PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer. The device is a single-use, sterile, non-pyrogenic medical device used to provide access for the administration of fluids from a container to a patient's vascular system.

The recall is being issued 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 product is identified by Lot No. 3316827 and Item No. 011-AM6118. The units were distributed to Italy, France, and the following US states: Arizona, Ohio, Texas, and Washington. Healthcare providers and facilities should stop using the affected devices and contact ICU Medical for further instructions.

The recalled product

Product: 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…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion Sets
Hazard: leak
device-defect
Affected units: 70

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. 3316827. Item No. 011-AM6118

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