The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1580-2021·Announced 2021-05-19

ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Leakage Defect

ICU Medical is recalling specific lots of Smallbore Trifuse Extension Sets because a molding defect may cause leakage in the inactivated position.

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 text describes a potential leakage defect without reporting any specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of REF CH3625 Smallbore Trifuse Extension Sets. The recall is due to a molding defect that may cause small amounts of leakage in the inactivated position of certain spinning and non-spinning Sprios male luers.

The affected product is a medical device used to provide access for the administration of fluids from a container to a patient's vascular system. The recall covers lots 5135756 and 5141854, which were distributed nationwide in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom.

Healthcare providers and consumers should stop using the affected lots and contact ICU Medical for further instructions.

The recalled product

Product
REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s…
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion Sets
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 26 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 26 products in this recall →

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