Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2636-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product 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, injuries, or specific health consequences, fitting the criteria for minor labeling errors.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 94-inch (239 cm) Y-Type Blood Sets with 170 Micron Filters, Hand Pumps, and MicroClave Clear Rotating Luer connectors. The recall involves Item Number MRSB-94 across eight specific lot numbers: 3254698, 3274464, 3281536, 3293649, 3306431, 3307309, 3310606, and 3338586. These devices are single-use, sterile, non-pyrogenic 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 is a labeling discrepancy regarding the presence of the chemical di(2-ethylhexyl) phthalate (DEHP).

The affected products were distributed nationwide in the United States to 29 states and in Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for instructions on return or replacement.

The recalled product

Product: 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Clear, Rotating Luer, Approx Priming Volume: 57.2 mL, 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 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 MRSB-94
Lot Number 3254698
3274464
3281536
3293649
3306431
3307309
3310606
3338586

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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