Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2625-2018·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, but the hazard is a minor labeling error regarding the presence of small amounts of DEHP, which fits the criteria for moderate severity involving minor labeling issues.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 99" (251 cm) 20 Drop Y-Type Blood Sets with 200 Micron Filter, Hand Pump, 2 Clave, and Rotating Luer. The affected devices are single-use, sterile, non-pyrogenic blood tubing accessories intended for needle-free withdrawal of blood.

The recall was initiated because some devices were labeled as "Does not contain DEHP" even though the product may contain small amounts of DEHP. This labeling discrepancy affects the accuracy of the product's chemical composition information.

The affected products were distributed nationwide in the United States to specific states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. The specific item number is B9449, and the affected lot numbers are 3310515, 3331699, 3331700, 3381369, 3393511, 3401836, and 3405441. Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected devices if found.

The recalled product

Product: 99" (251 cm) 20 Drop Y-Type Blood Set w/200 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…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Blood Administration Sets
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 (8)

Item Number B9449
Lot Number 3310515
3331699
3331700
3381369
3393511
3401836
3405441

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