Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1588-2021·Announced 2021-05-19

ICU Medical Recalls Spiros Administration Sets Due to Molding Defect

ICU Medical is recalling specific lots of Spiros administration sets because a molding defect may cause small amounts of 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 describes a potential for small amounts of leakage without reporting 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 CH3235 30-inch Spiros administration sets. These medical devices are used to provide access for the administration of fluids from a container to a patient's vascular system.

The recall is due to a molding defect that creates a potential for small amounts of leakage in the inactivated position of the spinning and non-spinning Spiros male luers. The affected product is identified by Reference CH3235 and Lot Number 5125276.

The affected units were distributed worldwide, including nationwide in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. Users should stop using the affected lots and contact the manufacturer for instructions.

The recalled product

Product: REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - 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 catheter (which is inserted into…
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.

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Same hazard · leakage