Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2624-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

ICU Medical is recalling 85-inch Y-Type Blood Sets because some units are labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

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 source text describes a labeling error regarding DEHP content without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 85" (216 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, Clave, and Rotating Luer. The recall is due to a labeling error where some devices are marked as "Does not contain DEHP" despite the possibility that the product contains small amounts of DEHP.

The affected blood tubing accessories are single-use, sterile, non-pyrogenic devices intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood. The recall covers specific lot numbers: 3332396, 3338446, 3347144, 3371146, 3374292, 3405438, 3423451, and 3426308, under Item Number B9405.

The devices were distributed nationwide in the United States to 28 states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and consumers should stop using the affected lots and contact ICU Medical for further instructions.

The recalled product

Product: 85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 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…
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 (9)

Item Number B9405
Lot Number 3332396
3338446
3347144
3371146
3374292
3405438
3423451
3426308

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