The Recall Desk
HighFDA (Devices)·Z-0704-2014·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. The hazard involves a potential leak in a sterile intravascular device, which poses a risk of harm (such as infection or fluid loss) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling certain lots of the NanoClave Needlefree Connector product line. The recall is being conducted because a small percentage of the devices may leak.

The affected product is the 28-inch (71 cm) Smallbore Extension Set with Anti-Siphon Valve, MicroClave T-Connector, Clamp, and Rotating Luer, Item # B33071-T, Lot # 2791245. The ICU Needleless Connector is a single-use, sterile, non-pyrogenic device intended as an accessory to intravascular administration sets for administering fluids to patients through a cannula placed in a vein or artery.

The recall involves 50 units. Distribution was worldwide, including 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. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices.

The recalled product

Product
28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular adminis
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard
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 (2)

  • Item # B33071-T
  • Lot # 2791245.

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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