Agency classClass IIOur severity:High FDA (Devices)·Z-0700-2021·Announced 2020-12-30

ICU Medical Recalls Spinning Spiros and ChemoAccess Infusion Components

ICU Medical is recalling specific infusion components due to a molding defect that may cause leaks, risking fluid 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 where injury has not yet been reported, consistent with the High severity criteria for potential exposure to hazardous medications or fluid path contamination.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of Spinning Spiros, SURPLUG ChemoAccess, and related administration sets. The recall involves 33,900 units distributed worldwide, including across the United States and numerous international countries.

The recall was initiated because a molding defect may cause the spinning versions of male luers to exhibit leaks. This fluid leakage 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 immediately. The specific lot numbers involved are 4605964, 4764534, 4903199, 4901115, 4849120, 4865839, 4895024, 4603209, and 4866030. Affected reference numbers include 060-CH2000S, 066-CH2000S, 066-CH3034, CH3762, and CH3763.

The recalled product

Product: Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male Luer, REF: 066-CH2000S; SURPLUG ChemoAccess 5" (13cm) Bag Spike Adaptor with Closed Male Luer, REF: 066-CH3034; 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, Clave…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion Components
Hazard: fluid-leakage
contamination
exposure-to-hazardous-medications
air-in-line
Affected units: 33,900

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 (9)

Lots: 4605964
4764534
4903199
4901115
4849120
4865839
4895024
4603209
4866030

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 · fluid leakage