Agency classClass IIOur severity:Severe FDA (Devices)·Z-0679-2014·Announced 2014-01-15

ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving medical devices intended for intravascular use are classified as Severe (Score 4), particularly given the risk of fluid leakage in a sterile environment.

Plain-English summary

ICU Medical, Inc. is recalling certain lots of the NanoClave Needlefree Connector product line. The specific product involved is the 8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102. This device is a single-use, sterile, non-pyrogenic accessory intended for intravascular administration sets to deliver fluids to patients through a vein or artery.

The recall is being conducted because a small percentage of the devices in the affected lot may leak. The recall covers 50 units from Lot No. 2764741. These products were distributed worldwide, including in the United States (specifically UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY, HI, and NC) and internationally to Canada, Belgium, India, Kuwait, and Australia.

Healthcare facilities and consumers who have these specific devices should stop using them and contact ICU Medical for instructions on return or replacement. The FDA has classified this as a Class II recall.

The recalled product

Product: 8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Intravascular Administration
Hazard: leakage
contamination-risk
Affected units: 50

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. 2764741

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 · leakage