Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2611-2018·Announced 2018-08-15

ICU Medical Blood Set Recall for Incorrect DEHP Labeling

ICU Medical is recalling blood sets labeled as DEHP-free that may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.

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, but the hazard is a labeling error regarding DEHP content rather than a structural defect or reported injury, fitting the criteria for moderate severity.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 32-inch blood sets with CLAVE Connectors. The affected devices are single-use, sterile blood tubing accessories intended for needle-free blood withdrawal. The recall is due to a labeling error where the devices were marked as "Does not contain DEHP" even though the product may contain small amounts of DEHP.

The affected product is Item Number 061-C6028, Lot Number 3414382. Distribution was worldwide, including nationwide distribution in the United States to 28 states and specific countries including Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa.

This is a Class II recall. Consumers and healthcare facilities should stop using the affected lots and contact the manufacturer for instructions on return or replacement.

The recalled product

Product: 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, 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 venipuncture devices for needle-free…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Blood Collection
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 (2)

Item Number 061-C6028
Lot Number 3414382

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