The Recall Desk
HighFDA (Devices)·Z-0254-2021·Announced 2020-10-28

ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the stopcock from sealing properly.

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 product (intravascular device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 22-inch intravascular administration sets. The recall involves a potential manufacturing defect on the internal surface of the NanoClave stopcock, which may inhibit a proper seal with the NanoClave spike. The affected product is a single-use, sterile, non-pyrogenic device used to administer fluids from a container to a patient's vascular system.

The recall covers 304,735 units distributed worldwide, including the United States and countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. The specific lot numbers involved are 4605591 and 4727498.

Healthcare facilities and consumers should stop using the affected products and contact ICU Medical for further instructions or a replacement.

The recalled product

Product
22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10887709051967(17)250201(30)50(10)4727498. The Intravascular Administration Set is a single use, st
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard

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)

  • Lot Numbers:4605591
  • 4727498.

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 99 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 99 products in this recall →

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