Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1570-2021·Announced 2021-05-19

ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

ICU Medical is recalling specific lots of Sprios administration 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 hazard involves a potential leakage defect without reported 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 CL3011 30-inch administration sets with integrated ChemoLock drip chambers. The recall is due to a molding defect that may cause small amounts of leakage in the inactivated position of the Sprios male luers.

The affected product is distributed worldwide, including in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. The specific lot number identified in the recall is 5125298.

Healthcare providers and patients should stop using the affected administration sets and contact ICU Medical for instructions on how to return or replace the product.

The recalled product

Product: REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Administration Sets
Hazard: leakage
molding-defect

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 →

Same manufacturer · ICU Medical, Inc.

See all →

High
ICU Medical Recalls CADD Yellow Medication Cassette Reservoirs Due to Leakage
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23

Same hazard · leakage