Agency classClass IIOur severity:High FDA (Devices)·Z-1579-2021·Announced 2021-05-19

ICU Medical Recalls Sprios Male Luer Administration Sets Due to Molding Defect

ICU Medical is recalling specific lots of Sprios male luer 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could lead to fluid leakage, posing a risk of harm to patients, but no injuries or illnesses have been reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger. The recall is due to a molding defect in certain lots of spinning and non-spinning Sprios male luer components. This defect creates a potential for small amounts of leakage in the inactivated position.

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 through a needle or catheter. The recall covers Lot Number 5125290 with an expiration date of January 1, 2026. The product was distributed nationwide in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom.

Healthcare facilities and consumers should stop using the affected lots immediately. Users should check their inventory for the specific lot number and reference number listed above. If the product is found, it should be quarantined and returned to ICU Medical, Inc. according to their instructions.

The recalled product

Product: REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", 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 catheter (which is inserted…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV 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 →

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Same hazard · leakage