The Recall Desk
HighFDA (Devices)·Z-0244-2021·Announced 2020-10-28

ICU Medical Recalls 128-inch Primary Sets Due to Seal Defect

ICU Medical is recalling specific lots of 128-inch primary sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 128-inch (325 cm) primary sets. The recall involves a potential manufacturing defect on the internal surface of the NanoClave component. This defect may inhibit a proper seal with the NanoClave spike.

The affected products are sterile, non-pyrogenic intravascular administration sets used to provide access for the administration of fluids from a container to a patient's vascular system. The recall covers a total of 304,735 units across lots 4711125 and 4718711.

The products were distributed nationwide in the United States and in several countries including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare facilities should stop using the affected lots and contact ICU Medical for further instructions.

The recalled product

Product
128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709011691(17)250201(30)50(10)4711125;(01)10887709011691(17)250201(30)50(10)4718711. The Intravas
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard

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 (2)

  • Lot Numbers:4711125
  • 4718711.

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 99 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 99 products in this recall →

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