The Recall Desk
HighFDA (Devices)·Z-0701-2021·Announced 2020-12-30

ICU Medical Recalls Spiros and Clave IV Administration Sets

ICU Medical is recalling specific Spiros and Clave IV administration sets due to a molding defect that may cause leaks in spinning male luer components.

What this means for you

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, fitting the criteria for a High severity score.

Plain-English summary

ICU Medical, Inc. is recalling approximately 55,000 units of various Spiros and Clave IV administration sets, extension sets, and oncology kits. The recall affects specific lots distributed nationwide in the United States and in numerous countries worldwide, including Italy, Belgium, the United Kingdom, Canada, Germany, and Australia.

The recall is due to a potential molding defect in the spinning versions of male luer components. This defect may cause fluid leakage, which could potentially lead to delays in infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or air in the fluid path.

Healthcare facilities and consumers should stop using the affected products and contact ICU Medical for further instructions. The affected products include various reference numbers such as 20123-01, CH3035, CH3135, and others listed in the official recall documentation.

The recalled product

Product
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135;
Manufacturer
ICU Medical, Inc.
Category
Medical Device — IV Administration Sets
Hazard
Affected units
55,000

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 →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · fluid leakage

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