Agency classClass IIOur severity:High FDA (Devices)·Z-0231-2021·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 potential failure of a medical device seal which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 10-inch (25cm) intravascular administration sets equipped with a 3-Port NanoClave Manifold and Check Valve. 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 was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within the affected lots. This defect may inhibit a proper seal with the NanoClave spike. The affected product is a single-use, sterile, non-pyrogenic device used to provide access for the administration of fluids from a container to a patient's vascular system.

The affected lot numbers are 4536743, 4573956, 4589954, and 4711180. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected sets. Consumers and patients should contact their healthcare provider or the recalling firm for further instructions regarding the use or replacement of these devices.

The recalled product

Product: 10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709080796(17)241201(30)50(10)4536743…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Intravascular Administration Set
Hazard: manufacturing-defect
seal-failure

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 (4)

Lot Numbers:4536743
4573956
4589954
4711180.

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