Agency classClass IIOur severity:High FDA (Devices)·Z-0253-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of NanoClave Intravascular Administration Sets due to a manufacturing defect that may prevent 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 defect poses a risk of harm to patients by potentially compromising the sterile seal of the device, although no specific injuries are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of NanoClave Intravascular Administration Sets. The recall involves 304,735 units distributed worldwide, including in the United States and several international countries. The affected product is a single-use, sterile device used to administer fluids to a patient's vascular system.

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 agency has classified this as a Class II recall.

Healthcare providers and consumers should check their inventory for the specific lot number 4714442. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product: 60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Intravascular Administration Set
Hazard: seal-defect
contamination-risk

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:4714442.

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