The Recall Desk
HighFDA (Devices)·Z-0245-2021·Announced 2020-10-28

ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave 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 defect poses a risk of harm to patients by potentially failing to seal properly, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 126-inch intravascular administration sets. The recall involves a total of 304,735 units distributed worldwide, including in the United States and various international countries.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within the sets. This defect may inhibit a proper seal with the NanoClave spike, which is used for the administration of fluids to a patient's vascular system.

Healthcare facilities and distributors should stop using the affected products and contact ICU Medical for further instructions. The affected lot number is 4630752.

The recalled product

Product
126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UDI:(01)10887709062365(17)250201(30)25(10)4630752. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access f
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 (1)

  • Lot Number:4630752.

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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