Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1577-2021·Announced 2021-05-19

ICU Medical Recalls Spinning Spiros Syringes Due to Leakage Defect

ICU Medical is recalling specific lots of 60mL Spinning Spiros syringes 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 defect involves a potential for leakage without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

ICU Medical, Inc. is recalling REF CH2060 60mL Syringes with Spinning Spiros, Red Cap. The recall is due to a molding defect that creates a potential for small amounts of leakage in the inactivated position of certain lots of spinning and non-spinning Sprios male luers.

The affected product is used to provide access for the administration of fluids from a container to a patient's vascular system through an administration set's needle or catheter. The specific lot number is 5125260, with an expiration date of 260101.

The product was 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 product and contact the manufacturer for further instructions.

The recalled product

Product: REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - 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 a vein).
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Syringes
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