Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2642-2018·Announced 2018-08-15

ICU Medical Recalls Blood Administration Sets Due to DEHP Labeling Error

ICU Medical is recalling 160,016 blood administration sets labeled as DEHP-free, though 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 is a minor labeling error regarding the presence of small amounts of DEHP, which fits the criteria for a moderate severity recall.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 100-inch 20 Drop Y-Type Blood Admin Sets with 200 Micron 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 products are single-use, sterile, non-pyrogenic devices intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood. The specific item number is Z1689, and the affected lot numbers are 69-352-SJ, 69-741-SJ, and 70-969-SJ.

Distribution was worldwide, including nationwide distribution in the United States to 29 states and to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Consumers and healthcare facilities should stop using the affected devices and contact ICU Medical for instructions on return or replacement.

The recalled product

Product: 100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, 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 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 (4)

Item Number Z1689
Lot Number 69-352-SJ
69-741-SJ
70-969-SJ

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