Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2626-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

ICU Medical is recalling 160,016 blood tubing sets because they were labeled as not containing DEHP, though they may contain small amounts.

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 due to a labeling error regarding DEHP content. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 99-inch Y-Type Blood Sets with 170 Micron Filters, Hand Pumps, and CLAVE Connectors. 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.

The affected products are identified by Item Number B9561 and Lot Numbers 3328073 and 3419595. These single-use, sterile, non-pyrogenic devices are intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

The devices were distributed nationwide in the United States to specific states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 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 (3)

Item Number B9561
Lot Number 3328073
3419595

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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