The Recall Desk
HighFDA (Devices)·Z-2723-2017·Announced 2017-07-19

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

ICU Medical is recalling 1,100 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 involves a medical device with a potential leak risk where no injuries or illnesses have been reported, fitting the criteria for a risk-of-harm product without reported injury.

Plain-English summary

ICU Medical, Inc. is recalling 1,100 units of 10-inch Smallbore Extension Sets with 6-Port NanoClave Manifold, Check Valve, Clamp, and Rotating Luer. The recall is due to a potential leak that can develop at the connection between the Female Luer and the NanoClave manifold.

The affected 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 specific lots involved are 3182596, 3204086, 3246762, 3263682, and 3295482, under Item No. AM6109.

These products were distributed to Italy, France, and the following US states: Arizona, Ohio, Texas, and Washington. Healthcare facilities and consumers should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, 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 a patients vascular system through the a
Manufacturer
ICU Medical, Inc.
Category
Medical Device — IV Administration Sets
Hazard
Affected units
1,100

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 (5)

  • Lot No. 3182596
  • 3204086
  • 3246762
  • 3263682
  • 3295482. Item No. AM6109

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 →

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Same hazard · leak

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