Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1578-2021·Announced 2021-05-19

ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that 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, but the source text describes a 'potential' for 'small amounts of leakage' without reporting any specific injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling REF CH3011 30-inch administration sets with integrated ChemoClave drip chambers. The recall affects specific lots, including Lot Number 5125297, which were distributed nationwide in the United States and in several international countries including Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom.

The recall is being conducted due to a molding defect in certain lots of spinning and non-spinning Sprios male luers. This defect creates a potential for small amounts of leakage in the inactivated position of the device. The product is used to provide access for the administration of fluids from a container to a patient's vascular system.

Healthcare providers and facilities should stop using the affected lots immediately. Consumers and patients should check their medical records or consult their healthcare provider to determine if they received the affected product. No specific instructions for disposal or return are provided in the source text.

The recalled product

Product: REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion Pumps & Administration Sets
Hazard: leakage
manufacturing-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 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
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23

Same hazard · leakage