The Recall Desk
HighFDA (Devices)·Z-2721-2017·Announced 2017-07-19

ICU Medical Recalls MicroClave Extension Sets Due to Leak Risk

ICU Medical is recalling 100 units of MicroClave extension set kits 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 medical 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 100 units of the "Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear" (Lot No. 3320753, Item No. 011-AM6123). These 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 through a needle or catheter.

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 consumers who have these specific units should stop using them and contact ICU Medical for further instructions.

The recalled product

Product
Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. 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 system through the administration sets needle or catheter (wh
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. 3320753. Item No. 011-AM6123

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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