Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2644-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

ICU Medical is recalling specific blood tubing sets because they were labeled as not containing DEHP, even though they may contain small amounts of the chemical.

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, but the source text identifies the issue as a labeling error regarding DEHP content without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 99-inch 20 Drop Y-Type Blood Sets with 200 Micron Filters, Hand Pumps, and Clave Connectors. The recall involves specific lot numbers including 70-412-SL, 71-175-Y1, 71-693-Y1, 73-163-HE, 73-842-HE, 74-718-JW, 74-991-JW, and 75-582-JW.

The reason for the recall is that some of these 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 sterile, non-pyrogenic 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. They were also distributed to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and consumers should check their inventory for the specific item number Z2001 and the listed lot numbers.

The recalled product

Product: 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, 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 venipuncture devices…
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 (9)

Item Number Z2001
Lot Number 70-412-SL
71-175-Y1
71-693-Y1
73-163-HE
73-842-HE
74-718-JW
74-991-JW
75-582-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