Agency classClass IIOur severity:High FDA (Devices)·Z-0689-2014·Announced 2014-01-15

ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may 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. The hazard involves a potential leak in a sterile medical device used for intravascular administration, which poses a risk of harm (such as infection or fluid loss) even though specific injuries are not reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling certain lots of the NanoClave Needlefree Connector product line. The specific product affected is the 6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001. The recall involves 4,000 units from Lot No. 2767365.

The recall is being conducted because a small percentage of the devices may leak. The NanoClave Needleless Connector is a single-use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration of fluids to a patient through a cannula placed in the vein or artery.

The affected products were distributed worldwide, including in the United States (UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY, HI, NC) and internationally to Canada, Belgium, India, Kuwait, and Australia. Healthcare facilities and consumers should stop using the affected lots and contact the manufacturer for further instructions.

The recalled product

Product: 6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Intravascular Administration Set
Hazard: leak
contamination
Affected units: 4,000

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. 2767365

Distribution

Distributed in 14 states:

Part of a larger recall action

This product is one of 50 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 50 products in this recall →

Same manufacturer · ICU Medical, Inc.

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Same hazard · leak