Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2658-2018·Announced 2018-08-15

ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error

ICU Medical is recalling specific blood tubing accessories 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: This is a Class II recall involving a labeling error regarding DEHP content. The rubric classifies minor labeling errors and voluntary precautionary recalls as Moderate severity.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 120-inch 10 Drop Primary Sets with CLAVE Connectors. The affected devices are single-use, sterile, non-pyrogenic blood tubing accessories 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 is a labeling error regarding the chemical composition of the device.

The affected products are distributed nationwide in the United States and in Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. The specific item number is Z4089, and the affected lot numbers are 69-717-SJ, 70-260-SL, 73-197-HE, and 74-725-JW. Healthcare facilities and distributors should stop using these specific lots and contact the manufacturer for further instructions.

The recalled product

Product: 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 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…
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 (5)

Item Number Z4089
Lot Number 69-717-SJ
70-260-SL
73-197-HE
74-725-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