The Recall Desk
HighFDA (Devices)·Z-2724-2017·Announced 2017-07-19

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

ICU Medical is recalling 100 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

What this means for you

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 sterile medical device used for vascular access, which poses a risk of harm (such as infection or fluid loss) even though no specific injuries are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling 100 units of 10-inch Smallbore Extension Sets with 6-Port NanoClave Manifold (Item No. AM6122, Lot No. 3321776). 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 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 products 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 received these specific units should contact ICU Medical for further instructions or replacement.

The recalled product

Product
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids
Manufacturer
ICU Medical, Inc.
Category
Medical Device — IV Administration Sets
Hazard
Affected units
100

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. 3321776. Item No. AM6122

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 →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · leak

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