Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2647-2018·Announced 2018-08-15

ICU Medical Recalls Blood Tubing Accessories Due to Mislabeling

ICU Medical is recalling 160,016 units of Y-Type Admin 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, which typically corresponds to a moderate severity score. The hazard is a labeling error regarding DEHP content, which is a minor labeling issue rather than a direct risk of serious injury or death.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 134-inch (340 cm) Y-Type Admin Sets with 170 Micron Blood Filters. The recall is due to a labeling error where the devices were marked as "Does not contain DEHP" even though the product may contain small amounts of DEHP.

The affected devices are single-use, sterile, non-pyrogenic blood tubing accessories intended for needle-free withdrawal of blood. The recall covers specific lot numbers: 72-895-HE, 73-182-HE, 73-874-HE, 74-010-JW, 75-762-JW, and 75-839-JW.

Distribution was worldwide, including nationwide distribution in the United States to 29 states and to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and consumers should stop using the affected devices and contact the manufacturer for instructions.

The recalled product

Product: 134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 2 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…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Blood Tubing
Hazard: mis-labeling
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 (7)

Item Number Z2717
Lot Number 72-895-HE
73-182-HE
73-874-HE
74-010-JW
75-762-JW
75-839-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