Agency classClass IIOur severity:High FDA (Devices)·Z-0276-2021·Announced 2020-10-28

ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect

ICU Medical is recalling specific lots of smallbore extension sets because a manufacturing defect may prevent the NanoClave from sealing properly.

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. The hazard involves a potential seal defect in a medical device used for intravascular administration, which poses a risk of harm, but the source text does not report any illnesses or injuries.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 8-inch smallbore extension sets with MicroClave Clear, NanoClave Clamp, and Rotating Luer. The recall involves a total of 304,735 units distributed nationwide in the United States and in several countries including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component. This defect may inhibit a proper seal with the NanoClave spike. The affected lots are identified by the following lot numbers: 4603254, 4630684, 4718516, 4514832, 4537159, 4558447, 4724820, and 4733554.

Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected products. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product: 8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062946(17)250101(30)50(10)4603254; (01)10887709062946(17)250201(30)50(10)4630684…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Intravascular Administration Set
Hazard: seal-defect
manufacturing-defect

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 (8)

Lot Numbers:4603254
4630684
4718516
4514832
4537159
4558447
4724820
4733554.

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 · seal defect