The Recall Desk
HighFDA (Devices)·Z-0219-2021·Announced 2020-10-28

ICU Medical Recalls Intravascular Administration Sets Due to Potential Seal Defect

ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal with the NanoClave spike.

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 potential seal defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 113-inch (287 cm) intravascular administration sets. The recall involves 304,735 units of the product, which is a single-use, sterile, non-pyrogenic device used to administer fluids from a container to a patient's vascular system.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The affected product is identified by Lot Number 4734446.

The affected products were distributed worldwide, including nationwide in the United States and in several international countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare facilities and consumers should stop using the affected lots and contact the manufacturer for further instructions.

The recalled product

Product
113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709120171(17)250201(30)50(10)4734446. The Intr
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 (1)

  • Lot Number:4734446.

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 →

Related recalls

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Same hazard · seal defect

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