The Recall Desk
HighFDA (Devices)·Z-0233-2021·Announced 2020-10-28

ICU Medical Recalls 139-inch Admin Sets Due to Potential Seal Defect

ICU Medical is recalling specific lots of 139-inch intravascular administration 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 139-inch (353 cm) 15 Drop Admin Sets with 3 MicroClave Clear, 4-Way Stopcock, and 3-Port NanoClave Manifold. The recall involves a total of 304,735 units distributed worldwide, including nationwide in the United States and in countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. The affected lot numbers are 4556713, 4603383, and 4573356.

The recall was initiated due to the identification of a potential manufacturing defect on the internal surface of the NanoClave component. This defect may inhibit a proper seal with the NanoClave spike. The Intravascular Administration Set is a single-use, sterile, non-pyrogenic device used to provide access for the administration of fluids from a container to a patient's vascular system.

Healthcare providers and facilities should check their inventory for the specific lot numbers listed above. If the affected products are found, they should be removed from use and returned to ICU Medical, Inc. according to the company's instructions.

The recalled product

Product
139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121147(17)250101(30)25(10)4556713; (01)10887709121147(17)250101(30)25(10)4603383; (01)1088770912
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 (3)

  • Lot Numbers:4556713
  • 4603383
  • 4573356.

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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