The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2629-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

ICU Medical is recalling 160,016 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 describes a labeling error regarding DEHP content without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 132" (335 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, CLAVE Connector, 4-Way Stopcock, Rotating Luer, and 1 Extension. The affected devices are single-use, sterile, non-pyrogenic blood tubing accessories intended for needle-free withdrawal of blood. The recall involves Item Number B9756 and specific lot numbers including 3352552, 3364782, 3371152, 3374346, 3384365, 3396189, 3402557, 3405457, 3408968, 3412099, 3423456, and 3426318.

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 a specific chemical component in the medical device.

The affected products were distributed worldwide, including nationwide distribution in the United States to states such as 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 consumers should check their inventory for the specific item and lot numbers listed and contact the manufacturer for further instructions.

The recalled product

Product
132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Stopcock, 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 sets or…
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Blood Administration
Hazard
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 (13)

  • Item Number B9756
  • Lot Number 3352552
  • 3364782
  • 3371152
  • 3374346
  • 3384365
  • 3396189
  • 3402557
  • 3405457
  • 3408968
  • 3412099
  • 3423456
  • 3426318

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 →

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