Agency classClass IIOur severity:High FDA (Devices)·Z-0702-2021·Announced 2020-12-30

ICU Medical Recalls Spiros Male Luer Connectors Due to Molding Defect

ICU Medical is recalling Spiros male luer connectors and administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.

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 risk-of-harm product (medical device) where injury has not yet been reported, and the agency classification is Class II, which aligns with the 'High' severity criteria for potential harm without confirmed incidents.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of Spiros male luer connectors and administration sets. The recall is due to a molding defect that may cause the spinning versions of these male luers to exhibit leaks.

Fluid leakage from these defects may potentially cause a delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line. The affected products were distributed worldwide, including nationwide distribution in the United States and in numerous international countries.

Healthcare facilities and consumers should check their inventory for the specific reference numbers and lot numbers listed in the official recall notice. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product: 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Luer, REF: CH2000S; Spinning Spiros Closed Male Luer, 10 units, REF: CH2000S-10…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion Components
Hazard: leakage
contamination
exposure-to-hazardous-medication
air-in-line
Affected units: 1,856,578

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lots: 4749745
4764622
4790769
4806298
4865663
4712177
4749754
4757981
4764633
4793559
4903194
4726692
4756786
4800185
4895432
4726695
4749730
4757614
4761878
4784740

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

Same manufacturer · ICU Medical, Inc.

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Same hazard · leakage