Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2616-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets with Inaccurate DEHP Labeling

ICU Medical is recalling specific 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, and the hazard involves a labeling error regarding chemical composition (DEHP) 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 137" (348 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, and 1 Ext. The affected devices are sterile, single-use blood tubing accessories with CLAVE Connectors intended for use as an adjunct to blood tubing sets or venipuncture devices 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 description.

The affected units were distributed nationwide in the United States to specific states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. The specific lot numbers involved are 3328524, 3338394, 3356920, 3371073, 3373902, 3405269, 3408891, and 3423406, under Item Number B30031. Healthcare facilities and distributors should verify their inventory against these lot numbers and follow the recalling firm's instructions for handling the affected units.

The recalled product

Product: 137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext, 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…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Blood Administration
Hazard: mis-labeling
chemical-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 B30031
Lot Number 3328524
3338394
3356920
3371073
3373902
3405269
3408891
3423406

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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