Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0202-2021·Announced 2020-10-28

ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of smallbore intravascular administration sets because a manufacturing defect 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source describes a potential manufacturing defect that may inhibit a proper seal. No illnesses, injuries, or deaths are reported in the source text, and the hazard is described as potential rather than confirmed harm, fitting the criteria for a moderate severity score.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 8-inch smallbore intravascular administration sets. These single-use, sterile devices are used to administer fluids from a container to a patient's vascular system. The recall involves a total of 304,735 units distributed nationwide in the United States and in several international countries, including Canada, Mexico, and various nations in Europe and Asia.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within the sets. This defect may inhibit a proper seal with the NanoClave spike. The affected product is identified by Lot Number 4572784.

Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for further instructions. Patients who have received these specific sets should consult their healthcare provider if they have concerns regarding the administration of their fluids.

The recalled product

Product: 8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709075334(17)250101(30)50(10)4572784. The Intravascular Administration Set is a single…
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 (1)

Lot Number:4572784.

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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