Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2610-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling

ICU Medical is recalling specific blood set accessories because they were 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 hazard is limited to a labeling error regarding DEHP content without reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 32-inch blood set accessories with CLAVE Connectors. The specific item number is 061-C6003 and the lot number is 3426030. These single-use, sterile devices are intended for needle-free withdrawal of blood as an adjunct to blood tubing sets or venipuncture devices.

The recall was initiated because some of these devices were labeled as "Does not contain DEHP" even though the product may contain small amounts of DEHP. This constitutes a labeling error regarding the chemical composition of the medical device.

The affected products were distributed nationwide in the United States to specific states including Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, and West Virginia. The products were also distributed to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Users should check their inventory for the specific item and lot numbers listed and contact the manufacturer for further instructions.

The recalled product

Product: 32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/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 Accessories
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-C6003
Lot Number 3426030

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.

See all →

High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23

Same hazard · mis labeling