Agency classClass IIOur severity:High FDA (Devices)·Z-0187-2021·Announced 2020-10-28

ICU Medical Recalls Smallbore Extension Sets Due to Manufacturing Defect

ICU Medical is recalling specific lots of 7-inch smallbore extension sets because a manufacturing defect on the NanoClave surface may inhibit a proper seal.

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 3/5 (High).

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

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 7-inch (18cm) smallbore extension sets with removable MicroClave, NanoClave T-Connector, clamp, and rotating Luer. The recall involves a total of 304,735 units distributed worldwide, including nationwide in the United States and in countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

The recall is due to a potential manufacturing defect on the internal surface of the NanoClave within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The affected lot numbers are 4590834, 4557481, 4536601, 4724818, and 4733548.

The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of these devices. Users should check their inventory for the listed lot numbers and contact the manufacturer or their supplier for further guidance.

The recalled product

Product: 7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051055(17)250101(30)50(10)4590834; (01)10887709051055(17)250101(30)50(10)4557481…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Intravascular Administration Set
Hazard: manufacturing-defect
improper-seal

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 (5)

Lot Numbers:4590834
4557481
4536601
4724818
4733548.

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 →

Same manufacturer · ICU Medical, Inc.

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Same hazard · manufacturing defect