The Recall Desk
HighFDA (Devices)·Z-0691-2014·Announced 2014-01-15

ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks

ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may 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 risk of harm (leaking) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling certain lots of the NanoClave Needlefree Connector product line. The recall involves 4,000 units of the 7" (18 cm) Smallbore Ext Set with 2 NanoClave, Clamp, and Rotating Luer (Part No. A1000, Item No. K7099-001, Lot No. 2767368). These single-use, sterile, non-pyrogenic devices are intended as accessories to intravascular administration sets for administering fluids to patients through a cannula placed in a vein or artery.

The recall was initiated because a small percentage of the devices may leak. The affected products were distributed worldwide, including in the United States (specifically UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY, and HI) and internationally to Canada, Belgium, India, Kuwait, and Australia.

Healthcare facilities and consumers should check their inventory for the specific lot number and part number listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to their instructions.

The recalled product

Product
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administr
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard
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. 2767368

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 →

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Same hazard · leak

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