Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2645-2018·Announced 2018-08-15

ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error

ICU Medical is recalling specific blood tubing accessories because they were labeled as not containing DEHP, despite potentially containing 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, and the hazard involves a labeling error regarding the presence of DEHP, which aligns with the rubric for minor labeling errors or low-risk contamination.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 98" (249 cm) Y-Type Admin Sets with 170 Micron Blood Filters. The affected devices are single-use, sterile, non-pyrogenic blood tubing accessories intended for needle-free withdrawal of blood. The recall involves Item Number Z2449, specifically Lot Numbers 75-760-JW and 75-958-JW.

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 labeling discrepancy is the primary reason for the recall action.

The affected products were distributed nationwide in the United States to 29 states, including Alabama, Arkansas, California, and Texas. Additionally, the devices were distributed to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for further instructions.

The recalled product

Product: 98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, 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 Tubing
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 Z2449
Lot Number 75-760-JW
75-958-JW

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