The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2638-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

ICU Medical is recalling 160,016 blood sets because some 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 due to a labeling error regarding DEHP content. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 162" Y-Type Blood Sets with 170 Micron Filters, Bulb Hand Pumps, and CLAVE Connectors. The recall is due to a labeling error where some devices were marked as "Does not contain DEHP" despite potentially containing small amounts of DEHP.

The affected devices are single-use, sterile, non-pyrogenic accessories intended for needle-free withdrawal of blood. The recall covers specific lot numbers including 70-577-SL, 70-753-SL, and others listed in the agency record. Distribution was worldwide, including nationwide distribution across 29 US states and sales to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa.

Healthcare facilities and consumers should stop using the affected blood sets and contact ICU Medical for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an…
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Blood Administration Sets
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 (19)

  • Item Number Z1278
  • Lot Number 70-577-SL
  • 70-753-SL
  • 71-103-Y1
  • 71-193-Y1
  • 71-536-Y1
  • 71-704-Y1
  • 71-989-Y1
  • 72-409-HE
  • 72-538-HE
  • 72-555-HE
  • 72-928-HE
  • 73-176-HE
  • 73-393-HE
  • 73-623-HE
  • 73-871-HE
  • 74-613-JW
  • 74-713-JW
  • 75-088-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 →

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