Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2608-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

ICU Medical is recalling 160,016 blood tubing sets labeled as DEHP-free because they may contain small amounts of DEHP.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level. The hazard involves a labeling error regarding DEHP content, which is a minor labeling issue rather than a direct structural defect or high-risk pathogen.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 108" 20 Drop Blood Sets with CLAVE Connectors. The affected devices are single-use, sterile, non-pyrogenic blood tubing accessories intended for needle-free withdrawal of blood. The recall is due to a labeling error where some devices were marked as "Does not contain DEHP" even though the product may contain small amounts of DEHP.

The affected products are Item Number 011-C6047, with Lot Numbers 3393617 and 3419260. Distribution was worldwide, including nationwide distribution in the United States to specific states and to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa.

Consumers and healthcare facilities should check their inventory for the specific item and lot numbers listed above. If the devices match the recalled description, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product: 108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Blood Administration
Hazard: mis-labeling
dehp-exposure
Affected units: 160,016

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 (3)

Item Number 011-C6047
Lot Number 3393617
3419260

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Part of a larger recall action

This product is one of 53 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 53 products in this recall →

Same manufacturer · ICU Medical, Inc.

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Same hazard · mis labeling