Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2651-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that 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, which typically corresponds to a moderate severity score. The hazard is a labeling error regarding DEHP content, which is a minor labeling issue without reported injuries or illnesses.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 139" (353 cm) Y-Type Blood Sets with 170 Micron Filters, Hand Pumps, and BCVs. The recall involves specific lot numbers including 71-008-HE, 71-530-Y1, and 71-732-Y1. The devices are single-use, sterile, non-pyrogenic blood tubing accessories intended 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 constitutes a labeling error regarding the chemical composition of the medical device.

The affected products were distributed nationwide in the United States to states including AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, and WV. International distribution included Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for instructions.

The recalled product

Product: 139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pierced Port, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Blood Administration
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 (12)

Item Number Z3267
Lot Number 71-008-HE
71-530-Y1
71-732-Y1
72-621-HE
72-929-HE
73-008-JW
73-186-HE
74-459-JW
74-740-JW
75-174-JW
75-637-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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