Agency classClass IIOur severity:High FDA (Devices)·Z-0246-2021·Announced 2020-10-28

ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect

ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike 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, 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 40-inch (102cm) intravascular administration sets. These are single-use, sterile, non-pyrogenic devices used to administer fluids from a container to a patient's vascular system. The recall involves a total of 304,735 units distributed worldwide, including across the United States and in countries such as 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 within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The affected product is identified by Lot Number 4603496.

Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for further instructions. Consumers should not use these devices if they have them in their possession.

The recalled product

Product: 40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709014531(17)250101(30)50(10)4603496. The Intravascular Administration Set is a single use, sterile, non-pyrogenic…
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 (1)

Lot Number:4603496.

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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