Agency classClass IIOur severity:High FDA (Devices)·Z-1582-2021·Announced 2021-05-19

ICU Medical Recalls Sprios Male Luer Administration Sets Due to Leakage

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 poses a risk of harm (leakage) to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of Sprios male luer administration sets, including both spinning and non-spinning variants. The recall is due to a molding defect that creates a potential for small amounts of leakage in the inactivated position. The affected product is identified by Reference 011-H2864-HSR and Lot Number 5142887.

These administration sets are used to provide access for the administration of fluids from a container to a patient's vascular system. The recall covers products distributed nationwide in the United States and internationally in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom.

Healthcare facilities and consumers should check their inventory for the specific reference and lot numbers listed in this notice. If the affected product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.

The recalled product

Product: REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - 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…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Administration Set
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 →

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Same hazard · leakage